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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 Stryker Global Modular Replacement System, Modular Replacement System and Modular Rotating Hinge Knee Component are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below.

Indications for the MRS Stems and Intercalary Stems (presented in K952970):

• This device is intended for use in patients requiring extensive reconstruction of the femur . and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
• The Intercalary System is intended for use in situations arising from femoral mid-shaft tumor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

• Femoral and/or proximal tibial replacement and total femoral replacement 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.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581):

• Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
Proximal femoral reconstruction secondary to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Replacement System Cemented Stems (presented in K040749):
Femoral and/or proximal tibial replacement due to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Rotating Hinge Knee System (presented in K002552):

• The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where 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 revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System (GMRS) is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System (MRS) or the Modular Rotating Hinge Knee System (MRH). The Modular Rotating Hinge Knee System is a tricompartmental knee system. The system consists of a stemmed femoral component and a stemmed tibial bearing component connected by a set of bushings and an axle. The MRH Tibial Rotating component is a part of the MRH system and mates with the GMRS Standard Proximal Tibia. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

The provided FDA 510(k) clearance letter and summary for the Stryker Orthopaedics Global Modular Replacement System, Modular Replacement System, and Modular Rotating Hinge Knee Component does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This document is a clearance letter indicating a determination of "substantial equivalence" to previously marketed predicate devices. It does not present novel performance data or studies against pre-defined acceptance criteria.

The key statements from the document that confirm this are:

• "Non-Clinical Testing: Non-Clinical testing was not required as a basis for substantial equivalence." (Page 8)
• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." (Page 8)

The submission focuses on adding a contraindication to the labeling, updating MRI Safety information, and making clerical updates to the Instructions for Use (IFUs). These changes do not necessitate new performance studies for substantial equivalence.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies because the provided document explicitly states that such testing was not required for this particular 510(k) submission.

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Indications for the MRS Stems and Intercalary Stems (presented in K952970):

· This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.

· The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection. or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

· Femoral and/or proximal tibial replacement and total femoral replacement 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.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)

· Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Modular Replacement System Cemented Stems (cleared in K040749):

· Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis. The subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

This document is entirely focused on a 510(k) premarket notification for a medical device called the "Global Modular Replacement System." It is a request for approval to market the device, and the content details its intended use, a comparison to legally marketed predicate devices, and a summary of its technological characteristics.

Crucially, this document does not contain any information about acceptance criteria, device performance testing results, ground truth establishment, sample sizes for training or test sets, expert qualifications, or MRMC studies for an AI/software device. The request is specifically for a physical medical device (hip and knee prostheses) and its purpose is to update labeling, including adding a contraindication and updating MRI safety information.

The sections you've requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC studies) are typically relevant for AI/Software as a Medical Device (SaMD) submissions where software algorithms are being evaluated for diagnostic or prognostic purposes.

Therefore, I cannot fulfill your request as the provided text does not contain the information you are asking for. It explicitly states:

"No additional testing was conducted for this submission, as the only changes being made are to modify the labeling to add a contraindication and an update to the MRI safety information to align with an FDA guidance document. Testing performed in the previously cleared premarket notifications is applicable to this submission." (Page 10)

This confirms that no new performance studies, as would be required for an AI/Software component, were performed or are detailed in this 510(k) submission.

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USTAR II Knee System

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 intended for cementless use only.

USTAR II Knee System, Stem

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma 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. Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
5. Joint instability resulting from excessive bone resection.

Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.

USTAR II Hip System

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.

This device is a single use implant and intended for cementless use only.

"United" USTAR II System is used for patients who need a special prosthesis for their particular indication, which may present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, one tumors resection, or trauma and may require a further operation or reconstruction.

USTAR II System includes two sub-systems, which is "USTAR II Knee System" and "USTAR II Hip System". USTAR II Knee System is designed as modular combinations. It offers a variety of component options for treatment of patients that require femoral component, tibial baseplate and tibial insert. The tibial augment, segment part and stem are provided for patient with more bone resection. USTAR II Hip System is designed as a modular system which is composed Proximal femoral component, Trochanteric claw, and Press-fit, RHS straight/curved stem.

This document is a 510(k) premarket notification for the "USTAR II System" by United Orthopedic Corporation. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of an AI/ML device.

Therefore, the requested information for an AI/ML device (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not applicable to this document.

The document describes a medical device (a knee and hip prosthesis system) and its non-clinical performance testing. It states that "Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices."

Here's what can be extracted regarding the device performance and testing for this non-AI/ML medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The document does not explicitly state quantitative acceptance criteria in a table format for diagnostic performance, as it's not a diagnostic AI/ML device. Instead, it lists non-clinical performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. The reported performance is that the device "met" or "demonstrates" parity with predicate devices.

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

• Not applicable. This pertains to a physical medical device (prosthesis), not an AI/ML diagnostic algorithm that uses a "test set" of data in the common sense. The testing performed involves mechanical and material properties.

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

• Not applicable. Ground truth establishment by experts is relevant for diagnostic AI/ML systems where human interpretation is the gold standard. For a physical device, performance is evaluated against engineering standards and validated test methods.

4. Adjudication method for the test set

• Not applicable. This concept belongs to the evaluation of human judgment in diagnostic AI/ML studies.

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 for evaluating how AI assistance impacts human reader performance in diagnostic tasks.

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

• Not applicable. This refers to a diagnostic algorithm's performance in isolation. The USTAR II System is a physical implant.

7. The type of ground truth used

• For the non-clinical tests (e.g., fatigue, wear, endotoxin), the "ground truth" is defined by established engineering and biological standards (e.g., ISO standards, USP pharmacopeial limits). The device is tested against these predefined performance benchmarks.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system that requires a "training set."

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

• Not applicable.

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Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)

I am sorry, but the provided text describes a medical device, the METS® MODULAR PROXIMAL FEMUR, which is a hip joint metal/polymer semi-constrained cemented prosthesis. The information focuses on its classification, intended use, indications for use, and a declaration of substantial equivalence to predicate devices based on non-clinical performance testing and clinical evaluation through published papers and post-market surveillance.

This document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for AI/algorithm-based performance. The document refers to "non-clinical performance testing" for the device's physical attributes (disassembly force testing) and "clinical evaluation... based upon published papers and post market surveillance" to support its substantial equivalence. These are not performance metrics for an AI system.
2. Sample size used for the test set or data provenance related to AI validation.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.) for AI models.
8. Sample size for the training set (for an AI model).
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device's performance, as the provided text pertains to a traditional medical implant and its regulatory submission, not an AI or algorithm-based device.

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The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only

The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

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