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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  • o osteoarthritis
  • traumatic arthritis, and o
  • avascular necrosis (not applicable to Physica TT Tibial Plate); o
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• . Moderate varus, valgus, or flexion deformities.
  In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
• · Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

AMF Revision 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 metaphyseal fixation in the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.

The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Physica system," a knee replacement system. This document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device, which typically involves performance metrics like sensitivity, specificity, accuracy, or other relevant statistically derived performance measures against a defined ground truth.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The "Physica system" is a physical knee replacement prosthesis, not an AI or software-as-a-medical-device (SaMD). Therefore, the concept of "device performance" in this context refers to biomechanical properties, material compatibility, and overall safety and efficacy in a surgical setting, not diagnostic or predictive performance.
• No "Acceptance Criteria" for AI Performance: The document discusses conformity to FDA guidelines and referenced standards for mechanical safety and materials, which are the "acceptance criteria" for a physical implant. It does not define statistical performance thresholds for an AI algorithm.
• No "Study Proving Device Meets Acceptance Criteria" for AI: The "non-clinical testing" mentioned primarily involves mechanical comparisons and material testing, not studies comparing algorithmic output to ground truth. The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence."
• No Ground Truth for AI: Since there's no AI component, there's no need for an "expert consensus," "pathology," or "outcomes data" to establish ground truth for algorithm training or testing.
• No Training or Test Set: Again, as there's no AI, there are no training or test datasets in the traditional sense.

Therefore, it is not possible to provide the requested table and information based on the provided PDF content.

The document's conclusion of "substantial equivalence" is based on:

• Comparison of intended use.
• Comparison of materials.
• Summary of technological characteristics.
• Preclinical (non-clinical) testing which primarily involved mechanical safety confirmation and material conformity.

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The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 1990's.

The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability.

The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting.

The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

Acceptance Criteria and Device Performance for Consensus® Knee System (K102927)

This submission (K102927) is primarily to expand the indications for the already cleared Consensus® Knee System (CKS) porous-coated components to allow for uncemented use. The non-clinical performance data provided specifically addresses the porous coating's mechanical and chemical properties, demonstrating its suitability for this expanded use.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a clear table outlining the specifications, acceptance criteria, and verification results for the modified surface (porous CoCr bead with Ti coating).

Note: For microstructure and abrasion, the "Acceptance Criteria" are listed as "N/A" in the table, indicating these are descriptive measurements rather than pass/fail thresholds in this summary. However, the reported values are provided as verification results. For corrosion, the results for both CoCr beads and Ti Coated CoCr Beads demonstrate a comparable or improved resistance against the breakdown potential.

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

The document describes non-clinical performance data which typically involves laboratory testing of materials and components, not clinical data from patients. Therefore, terms like "test set" in the context of patient data, "country of origin of the data," or "retrospective/prospective" studies are not applicable here.

The sample sizes for the mechanical and corrosion tests are not explicitly stated in this summary. It's common in such submissions for the detailed test reports (which would include sample sizes, testing methodologies, and raw data) to be referenced but not fully reproduced in the 510(k) summary. These tests are performed on material coupons or device components in a laboratory setting.

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

This question is not applicable to this submission. The "test set" here refers to material samples or device components tested in a lab. The "ground truth" is established by direct physical and chemical measurements (e.g., measuring dimensions, applying forces, assessing corrosion) using standardized test methods (like ASTM standards mentioned). Therefore, human expert consensus on image interpretation or clinical outcomes is not relevant for this type of non-clinical data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth, typically in clinical studies or image review. Since this involves non-clinical laboratory testing, there is no human adjudication process of this nature.

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

No MRMC study was done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is irrelevant for a submission concerning the material properties and expanded uncemented use of a knee implant.

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

No standalone algorithm performance study was done. This typically refers to the performance of an AI algorithm on its own. The Consensus® Knee System is a medical device (a knee implant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this non-clinical performance data is direct physical and chemical measurement against predefined specifications and ASTM standards. This includes:

• Physical dimensions and morphology (e.g., bead neck diameter, pore size, coating thickness).
• Electrochemical properties (e.g., critical potential, breakdown potential for corrosion resistance).
• Mechanical properties (e.g., static tensile strength, static shear strength, shear fatigue strength, rotating beam fatigue strength, mass and thickness loss from abrasion).

8. Sample Size for the Training Set

This question is not applicable. There is no AI model or algorithm being trained within the scope of this 510(k) submission. The data presented are for validating the material properties of the porous coating.

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

This question is not applicable, as there is no training set mentioned or implied in the context of this device submission.

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The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   The device is a single use implant.

The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.

The provided 510(k) summary for the Biomet Vanguard™ PS Open Box Porous Femoral Components explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, based on the provided document, the device did not undergo clinical testing to demonstrate its performance against specific acceptance criteria. Instead, it relied on an engineering justification including a Finite Element Comparison to show it was "functional within its intended use" and claimed substantial equivalence to legally marketed predicate devices (Maxim® Accel Knee System K023546 and Non-Cemented Porous Coated Knees K033489).

As such, I cannot provide information on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods, as these elements are typically part of a clinical study.

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The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis, where one or more compartments are involved.
2. Correction of varus, valgus or posttraumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.

The provided text is a 510(k) summary for the Ascent™ Porous Open Box PS Femoral Component. It describes the device, its intended use, indications for use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:

"Clinical and Non-Clinical Testing: None provided"

Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

In summary, the document does not contain the information requested in your prompt.

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