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The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

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U2 Total Knee System - PF+ is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.

USTAR II Total 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.

The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).

The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.

However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).

Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.

The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.

Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:

Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):

Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:

• Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
• Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.

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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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MOTO Medial, MOTO Lateral and MOTO Sphere Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The MOTO Partial Knee System Extension is a Medacta partial knee prosthesis portfolio extension including implantable devices, provided individually packed, sterile and single-use. Specifically, the purpose of this submission is to gain the clearance for: MOTO Sphere femoral components, made of Co-Cr-Mo according to ISO 5832-4 and available in 5 sizes with or without TiNbN coating. They are intended to replace the medial or lateral femoral compartment of the natural knee joint and must be implanted in combination with the tibial component of MOTO Medial or MOTO Lateral (K162084, K183029 and K213071); 7mm thick MOTO Medial and MOTO Lateral inserts fixed made of E-cross, available in 8 sizes and intended to be coupled with the subject MOTO Sphere femoral components as well as MOTO Medial or MOTO Lateral tibial components (K162084, K183029 and K213071).

The provided document is a 510(k) Clearance Letter from the FDA for the MOTO Partial Knee System Extension. This document grants clearance for a medical device (knee implant components) and describes its intended use and comparison to predicate devices, but it does not contain the detailed acceptance criteria and study results you are asking for regarding a software or AI-based device.

The prompt specifically asks for details about a study that proves the device meets acceptance criteria, including information on "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth," "training set," etc. These are all concepts related to the validation of Artificial Intelligence (AI) / Machine Learning (ML) enabled software as a medical device (SaMD), often used in diagnostics or image analysis.

The MOTO Partial Knee System Extension is an implantable medical device (hardware). The document explicitly states:

• "No clinical studies were conducted." This is a key indicator that a comparative effectiveness study involving human readers or standalone algorithm performance was not performed or required for this type of device clearance.
• The "Performance Data" section lists "Non-Clinical Studies" focusing on mechanical properties and biocompatibility (e.g., fatigue endurance, contact pressures, wear behavior, pyrogenicity, shelf-life). These are standard tests for orthopedic implants, not AI/ML software.

Therefore, because the provided text is for a hardware implant and not an AI/ML software device, I cannot extract the detailed acceptance criteria and study information related to AI/ML performance from this document.

To answer your request, I would need a 510(k) clearance letter or summary for an AI/ML-enabled medical device.

If you were to provide a document for an AI/ML device, the table and information would be structured as follows (but cannot be populated from the current input):

Acceptance Criteria and Study Proof for an AI/ML Device (Hypothetical, based on expected content)

Since the provided document is for a hardware implant (MOTO Partial Knee System Extension) and not an AI/ML-enabled software device, it does not contain the specific performance evaluation metrics, study designs (e.g., MRMC, standalone), or ground truth establishment methods typically associated with AI/ML device validation.

If this were an AI/ML device, the information requested would be typically found in a "Performance Data" or "Clinical Performance" section of the 510(k) Summary, detailing studies conducted to demonstrate the algorithm's accuracy, sensitivity, specificity, or impact on human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

• Absence or loss of both cruciate ligaments
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.

The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.

This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.

The document discusses the following non-clinical performance data:

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

   • This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.

   Acceptance Criteria (Implied)	Reported Device Performance (Implied)
   Sterilization Efficacy	Validated for VHP
   Shelf-Life Stability	Demonstrated stability
   Packaging Integrity	Demonstrated integrity
   Biocompatibility (Cytotoxicity)	Met biocompatibility requirements
   Material Properties	Maintained material characteristics
   Wear Resistance	Comparable to predicate (Pin-on-disk)
   Fatigue Strength (Lock Detail)	Met strength requirements
   Fatigue Strength (Tibial Post)	Met strength requirements

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

   • Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
   • Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.

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

   • Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.

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. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.

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

   • No. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable. This is not an AI/machine learning device requiring a training set.

In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.

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Intended Use:

The EMPOWR Revision Knee™ Symmetric TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The EMPOWR Revision Knee™ Symmetric TT (Trabecular Titanium) Cones are an optional accessory in primary or revision Total Knee Arthroplasty. The EMPOWR Symmetric TT Cones are sterile, single-use devices that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR Symmetric TT Cones are composed of Ti6Al4V alloy (per ASTM F1472 and ISO 5832-3) and feature a porous Trabecular Titanium (TT) structure on the external surface of the implant. The EMPOWR Symmetric TT Cones are additively manufactured via Electron Beam Melting in the same manner as the reference AMF TT Cones device.

This document is an FDA 510(k) clearance letter for a medical device: the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones).

It is crucial to understand that this document DOES NOT contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) clearance process for this orthopedic implant relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through bench testing (mechanical performance) and, in some cases, clinical data if significant differences exist. This is a very different type of clearance than for AI/ML devices, which require performance data related to algorithmic accuracy or clinical utility.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) because it is not present in this document.

The document states:

• "No animal data submitted."
• "No clinical data submitted."
• "All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate."

The performance testing listed focuses on mechanical properties (Dynamic Fatigue Testing, MR Conditional Labeling), which are relevant for an orthopedic implant but entirely different from the performance metrics and study designs expected for an AI/ML diagnostic or assistive device.

In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance data for an AI/ML device.

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The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:

• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.

The iBalance BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

These components are single use only and are intended for implantation with bone cement.

The Arthrex iBalance Partial Knee System encompass the following FDA cleared devices:

• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System

These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis.

The provided FDA 510(k) clearance letter for the Arthrex iBalance Partial Knee System does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

This document is a clearance letter for a physical medical device (a knee replacement system), not an AI-powered diagnostic or treatment algorithm. The "performance data" mentioned refers to non-clinical and in-vivo electromagnetic simulation related to the device's "MR Conditional" status, which is about its safety in an MRI environment, not its diagnostic or therapeutic accuracy as an AI would have.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, expert consensus, MRMC studies, etc.) from this document because it is not relevant to an AI/algorithm-based device study.

To provide the information you're looking for, I would need a 510(k) clearance letter or a clinical study report specifically detailing the performance evaluation of an AI/algorithm-based medical device.

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The Freedom® Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).

The Freedom® Total Knee System – Titanium Tibial Base Plate is intended for cemented and single use only.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785 and K200912 respectively.

The primary purpose of this special 510(k) Device Modification to the Freedom® Metal Backed Tibial Component (K090411) is to notify the FDA of the change in materials used to manufacture the tibial base plate from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) as an alternative material option for the tibial base plate.

The Titanium Tibial Base Plate is fabricated from Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique.

The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

This 510(k) clearance letter pertains to a Class II medical device, specifically the Freedom® Total Knee System - Titanium Tibial Base Plate (K251717). The submission is a special 510(k) Device Modification, indicating that the changes made to the device are well-defined and do not significantly alter the indications for use or raise new questions of safety and effectiveness.

The core change is the material of construction for the tibial base plate, shifting from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti-6Al-4V ELI). The design, geometry, surfaces, and locking features remain identical to the previously cleared predicate device (K090411).

Therefore, the acceptance criteria and the study proving the device meets these criteria primarily focus on mechanical performance and biocompatibility related to this material change, rather than extensive clinical efficacy studies or comparative effectiveness studies involving human readers, as would be typical for AI/software devices.

Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a material change for an orthopedic implant with identical design), the acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity, but rather involve demonstrating mechanical equivalence to the predicate device and biocompatibility of the new material.

Here's a table summarizing the implicit acceptance criteria based on standard regulatory requirements for such a device modification, and how the document indicates they were met:

Study Details (Relevant to Orthopedic Implants, Not AI)

The provided text describes a submission for an orthopedic implant and does not involve an AI/software component, nor does it detail a clinical study with human patients for AI performance evaluation. Therefore, many of the requested points regarding sample sizes for test/training sets, expert readers, ground truth for AI, MRMC studies, etc., are not applicable to this type of device clearance and are consequently not found in the document.

However, based on the information provided, here's what can be inferred/stated:

1. Sample size used for the test set and data provenance:

   • Test Set: Not applicable in the context of clinical AI performance data. For mechanical testing (ASTM F1800), standard test methods specify the number of samples required (e.g., minimum of 6 samples for fatigue per ASTM F1800-97), but the exact number used in this specific submission is not reported in the summary.
   • Data Provenance: Not applicable for AI performance data. For material and design, the device is manufactured by Maxx Orthopedics Inc. (Norristown, PA, USA) and Meril Healthcare Pvt. Ltd. (Vapi, Gujarat, India).

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

   • Not applicable as this is a mechanical and material modification, not an AI diagnostic device requiring expert interpretation of images for ground truth.

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

   • Not applicable for the type of device/study described.

4. 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. This type of study (MRMC, AI assistance) is not relevant or performed for this device. The submission is for a physical orthopedic implant with a material change.

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

   • Not applicable, as there is no algorithm or AI component in this device.

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

   • For the mechanical testing, the "ground truth" would be the engineering specifications and performance of the predicate device, alongside adherence to international standards (e.g., ASTM F1800).
   • For biocompatibility, the "ground truth" is established long-term clinical use data, compliance with ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications), and prior FDA clearances of devices using this material.

7. The sample size for the training set:

   • Not applicable (no AI training set).

8. How the ground truth for the training set was established:

   • Not applicable (no AI training set).

In summary, the FDA clearance for K251717 as a special 510(k) is based on demonstrating that the new Titanium Tibial Base Plate is mechanically equivalent to its predicate and that the new material is biocompatible and has a well-established history of safe use in similar orthopedic applications. The regulatory review focuses on engineering performance criteria and material biocompatibility rather than clinical performance data from patient studies or AI algorithm validation.

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The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.

This document is a 510(k) clearance letter for the Synicem Hip, Knee, and Shoulder Spacers. These are medical devices, specifically temporary implants used in two-stage revision arthroplasties following joint infections.

The information provided outlines the substantial equivalence of the Synicem Spacers to previously cleared predicate devices. It describes the device, its intended use, technological characteristics, material composition, sizes, and various performance tests conducted.

However, a critical point to understand is that this document DOES NOT describe an AI/ML-based device. It is a clearance for a traditional medical device (joint spacers). Therefore, many of the requested criteria related to AI/ML systems (such as test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document focuses on demonstrating that the new Synicem Spacers are "substantially equivalent" to existing, legally marketed predicate devices in terms of safety and effectiveness, based on non-clinical performance testing (mechanical, antibiotic elution), biocompatibility, and MRI safety.

Here's an analysis based on the provided document, addressing the applicable criteria and explicitly stating where information is not available due to the nature of the device:

Device: Synicem Hip Spacer, Synicem Knee Spacer, Synicem Shoulder Spacer
Type of Device: Traditional Medical Device (Non-AI/ML)

Acceptance Criteria and Reported Device Performance

Given that this is a traditional medical device (joint spacer) and not an AI/ML algorithm, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to relevant standards. There isn't a "performance metric" in the sense of accuracy, sensitivity, or specificity as one would expect for a diagnostic AI.

The acceptance criteria are implicitly met by demonstrating that the Synicem Spacers "met performance requirements and is substantially equivalent to the predicate device" across several categories.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Knee Spacers: Fatigue performance and wear testing performed. Results showed equivalence to predicate.
• Shoulder Spacers: Static and dynamic fatigue testing performed. Results showed equivalence to predicate. |
  | Antibiotic Elution Profile | Elution kinetics of gentamicin are equivalent to predicate devices. | Antibiotic Elution Kinetics testing conducted. Results demonstrated elution kinetics equivalent to predicate spacers. |
  | Biocompatibility | Biological safety suitable for intended use, in accordance with ISO 10993 standards and FDA guidance. | - Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Irritation (ISO 10993-23)
• Acute systemic toxicity (ISO 10993-11)
• Material mediated pyrogenicity (ISO 10993-11)
• Genotoxicity (ISO 10993-3)
• Intramuscular implantation (ISO 10993-6)
• Local Effects after Bone Implantation / Subchronic Systemic Toxicity (ISO 10993-6 and ISO 10993-11)
• Chemical characterization (ISO 10993-18)
• Toxicological risk assessment (ISO 10993-17)
  Conclusion: Materials are biologically safe and suitable for intended use. |
  | MRI Safety | Meet MR safety classifications as "MR Safe" or "MR Conditional" as determined by testing. | - Synicem Knee Spacer: "MR Safe"
• Synicem Hip and Shoulder Spacers: "MR Conditional"
  (Testing conducted according to FDA guidance) |
  | Sterilization & Shelf Life | Sterilization methods validated according to international standards and FDA guidance; packaging maintains functionality and safety. | Sterilized using well-established methods; validations performed following international standards and FDA guidance. Compatibility between packaging and sterilization ensured; packaging preserves functionality and safety throughout declared shelf-life. |

Study Details (Applicability to AI/ML context)

Since this is a non-AI/ML device submission, most of the requested study details pertinent to AI/ML performance validation are not applicable (N/A). The "study" here refers to the non-clinical performance testing done to establish substantial equivalence.

1. Sample size used for the test set and the data provenance:

   • N/A. This is not an AI/ML device. The "test set" would refer to the physical samples of the spacers used for mechanical, biocompatibility, and elution testing. The provenance would be the manufacturing site (United Kingdom).

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

   • N/A. This is not an AI/ML device requiring expert-labeled ground truth data. Performance for this device is based on objective measurements from mechanical and chemical tests, and biological assays.

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

   • N/A. Not applicable for objective non-clinical performance testing of a physical device.

4. 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. This is a physical medical device (joint spacer), not an AI system designed to assist human readers. MRMC studies are not relevant.

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

   • N/A. There is no "algorithm" in this device. Its performance is inherent in its physical and chemical properties.

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

   • N/A. The "ground truth" for this device's performance is established by validated engineering and scientific test methods (e.g., ASTM standards for material properties, ISO standards for biocompatibility, gravimetric analysis for elution profiles). It's based on physical measurements and biological reactions, not subjective interpretation requiring "expert consensus" in the diagnostic sense.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set."

8. How the ground truth for the training set was established:

   • N/A. Not an AI/ML device; no "training set" or "ground truth for training."

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