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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
  • osteoarthritis
  • traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• 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, PS Pro and HPS components are also indicated for:

• Absent or not-functioning posterior cruciate ligament;
• Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate varus, valgus, or flexion deformities.

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.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement.

Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Physica CR Porous Femoral components for total knee replacement, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information (acceptance criteria and study that proves the device meets the acceptance criteria), which is typically associated with the validation of AI/SaMD, is not directly applicable to this document. The document describes the device, its intended use, and indicates that substantial equivalence to predicate devices was demonstrated through non-clinical mechanical testing and comparisons.

Here's how I can describe the information requested if this were an AI/SaMD, and then explain what the provided document does say in terms of device performance:

As this document describes a physical medical device (knee implant) and not an AI/SaMD, the requested information regarding acceptance criteria and studies for AI/SaMD performance validation (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not present in the provided text.

However, I can interpret your request in the context of the provided document by outlining the performance evaluation conducted for this physical device as presented in the 510(k) summary.

Acceptance Criteria and Study for Physica CR Porous Femoral Components (Non-AI/SaMD Context)

The primary method to demonstrate "acceptance criteria" and "device performance" for this type of medical device in a 510(k) submission is through substantial equivalence to legally marketed predicate devices, supported by non-clinical (mechanical) testing and material characterization.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions "worst case components or constructs" were used for mechanical testing. It does not specify a numerical sample size for these tests.
• Data Provenance: The data comes from non-clinical mechanical testing conducted on physical components of the device, likely performed in a laboratory setting by the manufacturer (Limacorporate S.p.A. in Italy). It is not retrospective or prospective patient data.

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

• This question is not applicable as the ground truth for a physical medical device like a knee implant is established through objective engineering standards and mechanical test results, not through expert consensus on diagnostic images or clinical outcomes in the same way as an AI/SaMD. The "experts" involved would be engineering and material science professionals conducting and interpreting the tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments (e.g., image interpretation). Mechanical testing results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a physical knee implant, not an AI or a system that assists human readers. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical performance: The ground truth is defined by established engineering standards (e.g., ASTM F3210-22e1 for fatigue testing) and material specifications (e.g., ISO 5832-4 / ASTM F75 for CoCrMo, FDA Guidelines for PoroTi coating). The "ground truth" is that the device must meet these predetermined, objectively measurable criteria.
• For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design is based on established engineering principles and prior device designs.

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

• Not applicable. See point 8. The design and development process for a physical implant involves engineering principles, CAD, materials science, and testing against known biomechanical principles, rather than AI training data.

Ask a specific question about this device

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
  • o traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• 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, PS Pro and HPS components are also indicated for:
• Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate varus, valgus, or flexion deformities.

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 clinical judgment of 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 bone and are 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 Patellar component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.

The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E.

The PS PRO Femoral component is intended to be used with bone cement.

The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.

This document is an FDA 510(k) clearance letter for the Physica system, a knee replacement device. It primarily focuses on the device's substantial equivalence to previously cleared predicate devices through mechanical testing and a comparison of materials and intended use.

Therefore, the input does not contain information related to a study that proves a device meets acceptance criteria, especially not for an AI/software device. It lacks details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance (e.g., country, retrospective/prospective).
• Number of experts, their qualifications, and adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Training set sample sizes or how their ground truth was established.

In summary, this document is a 510(k) clearance for a physical medical device (knee prosthesis), not an AI/software device. It relies on non-clinical mechanical testing and comparison to predicates, not clinical studies or performance metrics typically seen with AI/ML device clearances.

Ask a specific question about this device

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.

Ask a specific question about this device

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

• · Non-inflammatory degenerative joint disease including
  • osteoarthritis
  • traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• · 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.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented tibial components.

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

Tibial liners and Patellar components made of conventional UHMWPE and cross-linked UHMWPE with Vitamin E are provided as part of the Physica system. The Tibial Plate is provided in cemented and uncemented versions.

The provided text describes a 510(k) premarket notification for the "Physica system," a total knee replacement system. It establishes substantial equivalence to predicate devices based on non-clinical testing and technological characteristics.

However, the document explicitly states that "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices."

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The submission relied on non-clinical testing and technological comparison for substantial equivalence.

Ask a specific question about this device