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1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

5. Joint instability resulting from excessive bone resection

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and PSC and intended for cementless use only.

"United" USTAR II System is used for patients who present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, tumor resection, or trauma and may require a further operation or reconstruction. The USTAR II System includes implanted arthroplasty components of both the USTAR II Knee System and USTAR II Hip System.

For the subject device, it's an extension line of 510(K) cleared device USTAR II System (K190100), which introduces two new variations:

1. Cemented curved stem, RHS, non-coated: diameter 17×200 mm
2. Tibial stem: stem length from 30mm to 150 mm by stem diameter from diameter 9 to diameter 24

The compatibility of cemented curved stem, RHS, non-coated and tibial stem is same as that of the 510(k) cleared USTAR II system (K190100).

Cemented Curved Stem, RHS, non-coated is an extension in terms of sizes to 510 (k) cleared device USTAR II system (K190100). Its design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Cemented Curved Stem, RHS, non-coated.

Tibial stem's design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Tibial Stem while the only difference lies in its specification

Please note: The provided FDA 510(k) clearance letter and summary describe a medical device (Stem Extension Line for the USTAR II System), which is an orthopedic implant. This document does not describe an AI/Software as a Medical Device (SaMD).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable to this type of device submission.

The provided text focuses on the mechanical and design equivalence of the new implant variations to a previously cleared predicate device. The "study" mentioned refers to non-clinical mechanical analyses.

Below is an interpretation of the requested points adapted to the context of this orthopedic implant:

Acceptance Criteria and Study for the Stem Extension Line (USTAR II System)

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the acceptance criteria are based on established international standards for the mechanical performance of prosthetic components and demonstrate equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of physical implants or test articles in the provided summary. For mechanical testing, typically a defined number of test samples are used per standard, but the specific quantity is not given here.
• Data Provenance: The studies are non-clinical mechanical analyses performed to international standards (ISO, ASTM). The origin of the "data" itself would be the laboratory where these mechanical tests were conducted. It's a prospective design verification process, not a retrospective or prospective clinical study with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a non-clinical, mechanical device clearance. "Ground truth" in the context of clinical interpretation or diagnosis by experts (e.g., radiologists) is not relevant here. Ground truth is established by standardized material properties, engineering specifications, and mechanical test results per the referenced ISO and ASTM standards. Experts involved would be engineers and material scientists responsible for the design, testing, and analysis, ensuring compliance with manufacturing and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to consensus readings or evaluations by multiple human experts in studies involving subjective interpretation (e.g., imaging, clinical outcomes). For mechanical testing, the results are quantitative and objective, measured against predefined acceptance criteria from engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic aids, particularly those involving human interpretation, and are commonly used for AI/ML in medical imaging. This submission concerns the mechanical safety and functionality of an orthopedic implant. No human reader involvement or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device is based on engineering standards and specifications. This includes:
  • Material properties: Verifying components meet specified material strengths and compositions.
  • Geometric tolerances: Ensuring dimensions align with design specifications.
  • Mechanical performance: Demonstrating the implant can withstand anticipated loads and stresses as defined by the ISO and ASTM test standards (e.g., fatigue life, static strength).
  • Equivalence to Predicate Device: The primary "ground truth" is that the new variations perform equivalently to or better than the already cleared predicate device under the same test conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. The "design" and "manufacturing process" are based on established engineering principles and prior validated designs (the predicate device).

9. How the ground truth for the training set was established

• Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this physical device, there is no method for establishing its "ground truth." The design and manufacturing processes are validated through engineering analyses and quality control processes to meet the required specifications and standards.

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Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

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The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:

1. Severe instability, gross deformity and/or bone loss
2. Failure of a previous knee reconstruction procedure.
3. Trauma or tumor resection
4. Absent or markedly insufficient collateral ligaments

The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.

This document is a 510(k) Premarket Notification from the FDA for the "ATTUNE™ Revision Hinge Knee" device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of an AI/software device.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable to this particular document as it is for a mechanical implant and not an AI/software product. The information provided relates to the non-clinical testing of the physical implant's mechanical and material properties.

However, I can extract the relevant information regarding the tests performed for the determination of substantial equivalence (analogous to proving the device meets certain performance standards for a mechanical device).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria with reported performance values in a direct side-by-side comparison. Instead, it states that "The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices." This implies that the device performed equivalently to the predicate devices in these tests, satisfying the FDA's requirement for substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on specific sample sizes for these tests (e.g., how many specimens were shear-tested or fatigue-tested). It also does not mention data provenance as these are mechanical/materials tests, not human data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for a mechanical medical device, not an AI/Software device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the established engineering and material science standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a mechanical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical tests listed (Shear, Fatigue, Wear, Stability, Contact Pressure, Biocompatibility, MRI Safety Evaluation), the "ground truth" would be established engineering standards, material science specifications, and regulatory requirements relevant to orthopedic implants.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable.

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The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Hinge Knee System implants are for cemented use only.

GUARDIAN™ Limb Salvage Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The GUARDIANTM Limb Salvage Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment: 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The DCW Modular Distal Femoral System is primarily indicated for procedures in which a variable resection length prosthesis is necessary to accommodate the condition of the femur, e.g. bone loss/removal in disease-related knee arthroplasty or a distally fractured femur. It is also indicated for revious total knee replacement where the femoral prosthesis has loosened, broken, or requires surgical removal for another medical reason. These indications are intended to provide relief of pain and restoration of knee function in skeletally mature patients.

Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions: 1. patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications. 3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The EVOLUTION® MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity: 4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Total Knee System nonporous components are for cemented use only. The EVOLUTION® Total Knee System porous components are for use without bone cement.

The ADVANCE® Total Knee System components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Total Knee System is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

The Whiteside Condylar II™ Total Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis or traumatic arthritis, with or without moderate valgus, varus, or flexion deformities. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. The prosthesis is also indicated for revision of a failed prosthesis where the cruciate ligaments are absent ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC® M.A. Total Knee System is indicated for use in conjunction with the metal tibial base of the Whiteside ORTHOLOC® II Total Knee System for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental or tricompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The AXIOM ACL Retaining Tibial Tray and Tibial Insert are used in total knee arthroplasty for replacement of the tibial plateau of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. AXIOM ACL Retaining Tibial Tray and Tibial Insert are for cemented use only.

The A/P Curved Tibial Insert is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The A/P Curved Tibial Insert is intended for cemented application only.

The Second Generation Knee System is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The Second Generation Knee System is intended for cemented application only.

The Whiteside ORTHOLOC® Modular Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis. where the cruciate ligaments are absent. This device is intended for cemented use only.

The Modular Femoral Component and Constrained Tibial insert are used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. Additional indications specific to the Modular Femoral Component and Constrained Tibial Insert include use in patients with anterior/posterior, varus/valgus, and rotational joint instability resulting from inadequate or absent cruciate and collateral ligaments, or who's knee can not be stabilized by usual soft tissue management. This device is intended for single use in a cemented application only.

The ORTHOLOC® Tibial Plastic Insert, as part the ORTHOLOC® Total Knee System, is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The system is also indicated for revision of failed prosthesis where the posterior cruciate and collateral ligaments are intended for cemented use only.

Total knee arthroplasty has been proved effective in reducing pain and in restoring functional knee motion. Such surgical procedures have been used in the management of: painful disabling bicompartmental joint disease secondary to osteoarthritis, theumatic arthritis; posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. The device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cemented use only.

The ORTHOLOC® ADVANTIM™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis, where the cruciate ligaments are absent.

The ULTRACK™ Total Knee System is intended for bicompartmental replacement of the knee joint for reduction of pain or increased function for the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity: 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. This device is intended for cemented use only.

The subject devices include the following affected components: Tibial spacers manufactured from UHMWPE; Tibial hinge base with stop pins manufactured from UHMWPE, titanium alloy, and cobalt chromium alloys; Hinge bushings manufactured from UHMWPE; Tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy, cobalt chromium tungsten allov, and cobalt chromium molybdenum alloy; Femoral axial pins manufactured from combination UHMWPE and cobalt chromium molybdenum alloy and combination high density polyethylene (HDPE) and cobalt chromium alloy; Yoke extension stops manufactured from UHMWPE; Patellae manufactured from UHMWPE and cobalt chromium tungsten alloy. The subject materials conform to the following standards: GUR 1050 UHMWPE conforming to ASTM F648; GUR 1020 UHMWPE conforming to ASTM F648; High-density polyethylene; Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy conforming to ASTM F136; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F75; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F799; GUR 1020 5 MRad Cross-linked Polyethylene conforming to ASTM F648; Cobalt-20Chromium-15Tungsten-10Nickel Alloy conforming to ASTM F90.

The provided text is a compilation of FDA 510(k) clearance letters and summaries for various knee and limb salvage systems manufactured by MicroPort Orthopedics Inc. These documents primarily address administrative changes related to sterilization suppliers and parameters and assert substantial equivalence to previously cleared devices.

Crucially, the documents explicitly state that "No bench testing, animal testing, or clinical testing was performed to support this submission" ([28]D, [37]D) and "Clinical data were not submitted or relied on for a determination of substantial equivalence" ([29]E, [37]E).

Therefore, based solely on the provided text, it's not possible to describe acceptance criteria or a study that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a newly designed medical device.

The "study" referenced in these documents is limited to:

• Validation of sterilization parameters (Ethylene Oxide Sterilization Validation Report) according to ISO standards (ISO 11135:2014, ISO/TS 21387, and ISO 10993-7:2008) to demonstrate the new supplier can achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility assessment of the materials, concluding no impact on biological safety due to the change in sterilization supplier/parameters.

The acceptance criteria here are related to the maintenance of sterility and biocompatibility following a change in the manufacturing process (specifically, the sterilization supplier and parameters) for devices that have already established substantial equivalence through previous 510(k) submissions.

Given this context, I will address the questions to the best of my ability based on the information provided, explicitly stating where information is "Not Applicable" or "Not Provided" due to the nature of this particular 510(k) submission (change in sterilization process for already cleared devices, not a new device performance study).

Acceptance Criteria and Study for Sterilization Process Change (based on the provided document)

The core "study" described in the provided text is the validation of a change in Ethylene Oxide (EO) sterilization supplier and parameters for a range of existing knee and limb salvage system implants. The device performance being "proven" here is the continued sterility and biocompatibility of these devices after this change, asserting they remain as safe and effective as their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for the sterilization validation or biocompatibility assessment. It states that the "subject sterilization process underwent sterilization" and that "biocompatibility assessment... was assessed" ([28]D, [37]D). Regulatory requirements for sterilization validation (e.g., ISO 11135) dictate specific sample sizes for sterility testing (e.g., bioburden, sterility tests). However, these specific numbers are not provided in this summary.
• Data Provenance: The data comes from internal validation studies conducted by MicroPort Orthopedics Inc. (or their contracted sterilization supplier) to support the change. The country of origin for the data is not explicitly stated, but MicroPort Orthopedics Inc. is based in Arlington, Tennessee, USA ([24] Submitted by, [30] Submitted by). The studies are prospective in the sense that they were conducted specifically to validate the new sterilization process before seeking 510(k) clearance for the change.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable in this context. This 510(k) submission is about validating a manufacturing process change (sterilization), not evaluating clinical performance or diagnostic accuracy. Therefore, there is no "ground truth" established by clinical experts for a test set in the sense of image interpretation or medical diagnosis. The "ground truth" for sterilization is defined by established international standards (ISO series) for achieving a specific SAL, and for biocompatibility, by biological safety assessments.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical or diagnostic test set requiring expert interpretation or consensus was performed, no adjudication method was used. The assessment relied on adherence to scientific and engineering standards for sterilization and material biocompatibility.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. The device type (knee and limb salvage system implants) is a physical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. The devices are physical implants, not algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for this submission revolves around compliance with established international standards for sterilization and biocompatibility:
  • Sterilization: The ground truth is the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ as defined by ISO 11135:2014 and ISO/TS 21387.
  • Biocompatibility: The ground truth is the absence of adverse biological reactions as demonstrated by assessment against ISO 10993-7:2008 and other relevant biocompatibility standards, ensuring material properties and device characteristics are unaffected.

8. The Sample Size for the Training Set

• Not Applicable. This submission is not for a new device development involving a "training set" for an algorithm. The "training" in this context refers to manufacturing process validation.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As above, no training set for an algorithm exists here. The "ground truth" for the overall device's safety and effectiveness was previously established by the predicate devices which had undergone their own respective regulatory clearances, covering aspects like design, materials, and clinical performance (if applicable). This 510(k) only addresses the impact of a change in sterilization supplier on these already established devices.

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ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

LPS TM Limb Preservation System Indications for Use
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• · malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.
  The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
  The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
  The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

This document (K233980) is a 510(k) premarket notification for several DePuy knee systems. It primarily focuses on adding updated MRI compatibility information and standardizing language in the Instructions for Use (IFU) and labels. The core claim for substantial equivalence relies on non-clinical performance data related to MRI safety and bacterial endotoxin testing, rather than a clinical study of device performance in a human-in-the-loop or standalone AI context.

Therefore, the requested information regarding acceptance criteria, study design for device performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from this document as it pertains to a different type of device (knee implants) and regulatory submission (510(k) for labeling changes related to MRI safety, not an AI/software as a medical device performance study).

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted, and the reported performance as implied by the conclusion of substantial equivalence.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

For MRI safety, the acceptance criteria are implicit in meeting the standards listed. The reported "performance" is that the devices meet these standards, thus proving MRI safety.

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here would refer to the physical devices tested for MRI compatibility and bacterial endotoxin. The document does not specify the number of individual devices subjected to these non-clinical tests.
• Data Provenance: Not applicable for a typical AI/software study. The "data" here are the results from physical and chemical testing of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as there is no "ground truth" established by experts in the context of an AI or diagnostic device study. The ground truth for these tests is defined by the physical properties measured according to established ASTM and ANSI standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable as this is not an image-based or diagnostic AI study requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." (pages 6, 9, 12, 15)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable as the device is a knee implant, not an algorithm or software. The "performance" assessment is of the physical and material properties of the implant itself in relation to MRI safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests is established by the physical and chemical properties measured according to the specified ASTM and ANSI international standards for MRI compatibility and bacterial endotoxin levels.

8. The sample size for the training set

• Not applicable. There is no AI model or training set involved in this regulatory submission.

9. How the ground truth for the training set was established

• Not applicable. There is no AI model or training set involved in this regulatory submission.

In summary: This FDA 510(k) submission for DePuy knee systems is related to changes in labeling for MRI compatibility, not an AI/software/diagnostic device. The "study" described focuses on non-clinical bench testing to demonstrate MRI safety and bacterial endotoxin compliance, adhering to recognized industry standards, rather than clinical performance or AI algorithm validation.

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The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:

2. inflammatory degenerative joint disease including rheumatoid arthritis;

3. correction of functional deformity:

4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Hinge Knee System implants are for cemented use only.

The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:

• a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
• a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
• a yoke extension stop offered in 3 options (0°, 5°, 10°)
• a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
• a tibial base offered in two variants:
  • modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
  • monolithic (3 sizes, 1-3) with fixed small keel o
• . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
• Universal femoral augments
  • distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
  • posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
• Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses

Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.

The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.

The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a knee system, primarily discussing its substantial equivalence to previously marketed devices based on non-clinical testing, design features, and materials.

It explicitly states:

• "Clinical data were not provided for the subject device." (Page 7, Section E. Clinical Testing)

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on mechanical and material testing, and substantial equivalence, not a clinical study involving an AI or diagnostic device with acceptance criteria for performance metrics like sensitivity or specificity.

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Triathlon® Hinge Knee System:
Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• · There is destruction of the joint surfaces, with or without significant bone deformity.
• · The cruciate and/or collateral ligaments do not stabilize the knee joint.
• · The ligaments are inadequate and/or the musculature is weak. And/or
• · Revision is required of a failed prosthesis where has been gross instability, with or without bone loss or inadequate soft tissue.
• · And/or where segmental resection and replacement of the distal femur is required.

Triathlon® Revision Insert X3®:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques. Additional Indications for Total Stabilizer (TS) Components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.
• · Severe instability of the knee secondary to compromised collateral ligament integrity or function.

The previously cleared Triathlon® Hinge Knee (THK) System (K223528) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of Modular Rotating Hinge (MRH) bushings and MRH axle (K222056, K002552, K994207). A bumper locks this assembly. This assembly provides motion through the MRH axle/bushing combination in the flexion/extension plane. The articulation between bearing surfaces on the underside of a tibial bearing component and a hinge tibial insert provide motion in the rotating plane. A hinge tibial insert is assembled to a revision tibial baseplate which incorporates a longitudinal bore to accept a Triathlon® tibial sleeve or an MRH tibial sleeve. Optional distal femoral and tibial augments are available to fill bone defect. The Instructions for Use and package labels for the THK components are being updated to bear the MR Conditional symbol and MR Conditional parameters.

The subject Triathlon® Bushing and Axle (Standard Assembly Pack) contains sterile, singleuse devices that are being added to the previously cleared THK System (K223528) as an alternate option to MRH bushings and MRH axle to connect a stemmed femoral component and a stemmed tibial bearing component and provide motion through the flexion/extension plane.

This premarket notification also introduces the subject Triathlon® Revision Insert X3®, which is a sterile, single-use device that is intended for use in a total knee arthroplasty with the previously cleared Triathlon® Revision Tibial Baseplate (K223528) and Triathlon® TS Femoral Component (K172326, K141056, K070095) as part of the Triathlon® Total Knee System. The subject insert is available in seven sizes, and each size is available in seven different thicknesses. The subject insert is packaged together with Cobalt-Chrome (CoCr) stabilizer pin and filler bushing subcomponents that are assembled intraoperatively. The subject insert is assembled to the previously cleared Triathlon® Revision Baseplate (K223528), which incorporates a longitudinal bore to accept the filler bushing subcomponent. The stabilizer pin is inserted through the subject Triathlon® Revision Insert X3® and extends into filler bushing assembled within the Triathlon® Revision Tibial Baseplate to provide additional stability in the insert post.

This FDA K-number document (K230416) is for a medical device, specifically orthopaedic implants (knee systems), and thus does not involve acceptance criteria or studies related to AI/ML device performance. The document only lists pre-clinical (non-clinical) testing performed on the device components, such as materials characterization, wear analysis, fatigue testing, and biocompatibility, to demonstrate substantial equivalence to predicate devices. There is no mention of an algorithm or AI model, nor any associated acceptance criteria, study designs, or ground truth establishment relevant to AI/ML performance.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on the provided document. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

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The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

• · There is destruction of the joint surfaces, with or without significant bone deformity
• · The cruciate and/or collateral ligaments do not stabilize the knee joint
• · The ligaments are inadequate and/or the musculature is weak and/or
  · Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

• · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed;
• · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
• · irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

• 2. Rheumatoid arthritis;

3. Correction of functional deformity:
4. Revision procedures where other treatments or devices have failed;
5. Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
6. Irreparable fracture of the knee
   When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
   The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
7. There is destruction of the joint surfaces, with or without significant bone deformity.
8. The cruciate and/or collateral ligaments do not stabilize the knee joint.
9. The ligaments are inadequate and/or the musculature is weak and/or,
10. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

• Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
• Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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This Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• · There is destruction of the joint surfaces, with or without significant bone deformity.
• · The cruciate and/or collateral ligaments do not stabilize the knee joint.
• · The ligaments are inadequate and/or the musculature is weak. And/or
• · Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or madequate soft tissue.
• · And/or where segmental resection and replacement of the distal femur is required.

The subject THK System is a line extension to the existing Triathlon® Knee System and will be a modified version of the predicate Modular Rotating Hinge (MRH) Knee System and Triathlon® Total Knee System. The THK System is a tricompartmental knee system consisting of a new hinge femoral component and a new tibial bearing component connected by a set of previously cleared MRH bushings and an MRH axle (K994207, K002552). A new bumper locks this assembly. This assembly provides motion through the MRH axle/bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of the new tibial bearing component and a new hinge tibial insert provides motion in the rotating plane. The hinge tibial insert is assembled to a new revision tibial baseplate which incorporates a longitudinal bore to accept a new tibial sleeve or previously cleared MRH tibial sleeve (K994207, K002552). Optional new distal femoral and tibial augments are available to fill bone defects.

The THK System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constraint by the bearing surface radius on the tibial bearing component, and an extensive range of size, modularity, and resection options. The subject THK System consists of:

• Hinge Femoral Components in six sizes and in left and right configurations o
• Revision Tibial Baseplates in seven sizes O
• Hinge Inserts in seven sizes and five thicknesses each hinge insert is packaged with a O standard sleeve subcomponent
• Tibial Bearing Components in three sizes O
• Bumper inserts in neutral and three degree flexion options O
• Revision Tibial Augments in eight sizes, two thicknesses and in right medial/left lateral and O right lateral/left medial options
• o Femoral Distal Augments in six sizes and two thicknesses.

The components of the subject THK System are sterile, single-use devices intended for cemented use only. They can be used with previously cleared Modular Rotating Hinge (MRH) Knee components (K994207, K002552), the Global Modular Replacement System (GMRS) (K023087), and Triathlon® Knee System components (K172634, K172326, K190991, K143396, K141056. K132624. K070095. K061521. K053514. K052917. K051948. K051146. K040267).

This document is a 510(k) Premarket Notification from the FDA regarding the "Triathlon® Hinge Knee System". It describes a medical device, specifically a knee replacement system, and outlines the non-clinical testing performed to establish its substantial equivalence to previously cleared predicate devices.

Crucially, this document states: "Clinical testing was not required as a basis for substantial equivalence."

This means that a study proving the device meets acceptance criteria involving human performance or clinical outcomes was not conducted or submitted for this 510(k) clearance due to the nature of the device (a modification/line extension of existing, cleared devices) and the regulatory pathway followed.

Therefore, I cannot provide the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance (in a clinical context)
• Sample sizes for a test set (clinical)
• Number of experts for ground truth establishment (clinical)
• Adjudication method (clinical)
• MRMC comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used (clinical)
• Sample size for a training set (clinical)
• How ground truth for a training set was established (clinical)

All the testing described in the document under "Non-Clinical Testing" (pages 6-7) relates to engineering analysis, materials characterization, mechanical fatigue testing, wear analysis, biocompatibility, and shelf-life validation. These are physical and mechanical performance tests comparing the new device to the established performance characteristics of predicate devices, not studies involving human subjects or AI performance.

The document's conclusion reinforces this: "Based upon a comparison of the intended use, indications for use, design, materials and sterilization method, performance characteristics, and operational principles, the components of the subject THK System are substantially equivalent to those of the predicate devices identified in this premarket notification." The substantial equivalence is based on non-clinical data.

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General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or os- teosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: - · Primary and secondary osteoarthritis. - Rheumatoid arthritis. - · Revision after primary or revision total knee replacement. - · Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis. - · Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers. The LINK Endo-Model EVO Pure Hinge is additionally indicated for: · Extreme cases of varus/valgus deformities (20-30°), theumatoid arthritis, muscular deficiency and any kind of genu laxum. · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO -W and the Megasystem-C) The LINK Endo-Model EVO Rotating Hinge is additionally indicated for: · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO - W and the Megasystem-C) General Indications Link OptiStems: The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL. LINK Endo-Model EVO-M. and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only. Indications: · Revision arthroplasty due to juxta-articular bone defects. - · Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. - · Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects. · Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M/ - W).

The LINK Endo-Model EVO Knee System is available in multiple versions with different applications, characteristics, and materials. The LINK Endo-Model EVO is a constrained total knee prosthesis, which is based on the previously cleared LINK Endo-Model Knee System (K143179, K152431, K212742), and is considered an evolution ('EVO') of the previous designs. The Knee System is available in two different hinge designs - Rotating Hinge and Non- rotating (Pure) Hinge. Also like the previously cleared system, the subject LINK Endo- Model EVO is available in two versions - LINK Endo-Model EVO Standard and LINK Endo-Model EVO - Modular. The femoral and tibial components of the standard version have fixed stems while the femoral and tibial components of the modular system are available with stems having a taper connection. The modular system includes femoral components with either a male taper or a female taper, and are designated as LINK Endo-Model EVO-M (male taper) and Endo-Model EVO-W ("weiblich" = female taper). The LINK Endo-Model EVO - Standard consists of a cemented monoblock femoral component made from CoCrMo and cPE and a cemented monoblock tibial component made from CoCrMo and an articulating surface made from cPE. The Standard System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – M consists of a cemented modular femoral component made from CoCrMo, Ti6A14V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – W intracondylar and condylar replacements consists of a cemented modular femoral component made from CoCrMo, Ti6Al4V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The femoral components can be used with distal and femoral (straight and L-shaped) segments made from Ti6A14V (Tilastan). The modular tibial components can be used with tibial spacers made from Ti6Al4V (Tilastan). The femoral and tibial components Rotating Hinge versions are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LINK Endo-Model EVO Knee System. It is made from cPE. The LINK Endo-Model EVO Knee System femoral and tibial components are compatible with the previously cleared LINK Endo-Model Knee System (K143179, K152431 and K212742). The femoral components of the LINK Endo-Model EVO – W are compatible with the previously cleared LINK MEGASYSTEM-C (K151008). The LINK Endo-Model EVO Knee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364). The Link OptiStems are an expansion of the modular stem portfolio. The Link OptiStems consist of a modular stem, adapter and fixation screw. The Link OptiStems come in cemented and cementless version. The Link OptiStems have to be joined and implanted in combination with the Femoral Components of LINK Endo-Model SL (K151008) or LINK Endo-Model EVO – M / -W.

The provided text is a 510(k) summary for the LINK Endo-Model EVO Knee System. It details the device description, indications for use, and a comparison to predicate devices, along with performance testing.

However, this document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-enabled medical device.

The document states:

• "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This explicitly indicates that a clinical study, which would typically involve human subjects and the type of performance evaluation (e.g., accuracy, sensitivity, specificity) relevant to AI/ML devices, was not performed.
• The "Performance Testing" section lists non-clinical tests such as "Range of Motion analysis," "Wear analysis," "Particle analysis," "Tibial baseplate component fatigue testing," "Contact area/stress analysis," and "Fretting / Corrosion." These are mechanical and material performance tests typically done for orthopedic implants, not software or AI algorithm performance.

Therefore, I cannot provide the requested information based on the given text. The details about acceptance criteria, test set size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set, and ground truth establishment are not present in this regulatory submission for a knee implant.

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