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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.

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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
  • o traumatic arthritis, and
  • o 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.

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.

Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.

The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Physica LMC Knee System. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), or clinical/non-clinical testing data to prove the device meets acceptance criteria.

The document explicitly states:

• "Non-Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."
• "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."

Therefore, I cannot provide the requested information. The 510(k) summary only discusses changes to the indications for use and surgical technique, asserting substantial equivalence based on these changes to already cleared predicate devices, rather than presenting new performance data.

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

• · Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
• · 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.

In patients with preserved and well functioning collateral ligaments. Physica PS components are also 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 metaphysed fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The AMF Revision TT Cones are intended to be used as an optional accessory component in Total Knee Arthroplasty in combinations with the Physica tibial plate (K141934, K151266 and K152008) and Physica PS femoral component (K152008). The AMF Revision TT Cones are one-piece devices, conically shaped with cannulation all the way through the cone.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to LimaCorporate S.p.A. for a knee joint prosthesis component. It discusses:

• Device Name: AMF Revision TT Cones
• Regulation Number and Name: 21 CFR 888.3560, Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis
• Regulatory Class: Class II
• Product Codes: JWH, MBH
• Indications for Use: For use in knee arthroplasty for various conditions, including revision procedures, and specifically for patients with bone defects or poor bone quality requiring supplemental metaphyseal fixation.
• Predicate Devices: Zimmer Trabecular Metal Knee System Augments and Stryker Triathlon Tritanium Cone Augments.
• Summary of Technology Comparison: States substantial equivalence in intended use, principles of operation, design, materials, sterility, and fixation methods to predicate devices.
• Non-clinical testing: Mentions "Fatigue resistance of the Physica System with AMF Revision TT Tibial Cones" tested using an internal protocol derived from ASTM F1800.
• Clinical testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF Revision TT Cones to the predicate devices."

Therefore, there is no information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, without the need for clinical studies as described in your request.

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Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.

When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.

When used in partial hip arthroplasty, they are intended for use with bipolar heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;

• rheumatoid arthritis;

· revisions in cases of good remaining femoral bone stock;

· treatment of femoral head and neck fractures.

The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.

When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:

• . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
• Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.

When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.

The C2 femoral stem is made of Ti6Al4V conforming to the specifications ASTM F1472 - ISO 5832-3. The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.

The C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.

This document is a 510(k) premarket notification for a medical device called the "C2 femoral stem." It is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. Therefore, it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance, or a study to prove an AI/ML device meets acceptance criteria.

The document details the device's intended use, description, and comparison to predicate devices, and refers to non-clinical testing for fatigue resistance as part of demonstrating substantial equivalence.

Here's the information that is available in the document, which primarily focuses on the regulatory submission process for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
* Not Applicable. This document is for a traditional medical device (a femoral stem implant), not an AI/ML powered device. Therefore, no acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC) are presented.
* The document mentions fatigue resistance tests according to ISO 7206-4 and ISO 7206-6. It states, "The tests results demonstrated the device's ability to perform under expected clinical conditions." However, no specific quantitative acceptance criteria or reported performance values (e.g., cycles to failure, load limits) are provided in this summary.

2. Sample size used for the test set and the data provenance:
* Not Applicable for an AI/ML test set. For the non-clinical fatigue testing, the document states, "All mechanical tests were performed on worst case components or constructs." The specific number of samples (e.g., number of stems tested) for these mechanical tests is not disclosed in this summary. Data provenance is not relevant in the context of these physical component tests.

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 an AI/ML device requiring expert-established ground truth.

4. Adjudication method for the test set:
* Not Applicable. This is not an AI/ML device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not Applicable. This is not an AI/ML device and therefore no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:
* For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and ISO standards (ISO 7206-4, ISO 7206-6) for fatigue performance. Meeting these standards demonstrates the device's mechanical integrity.

8. The sample size for the training set:
* Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:
* Not Applicable. This is not an AI/ML device.

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Physica CR total knee 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, or avascular necrosis;
• · 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.
  Physica CR knee system is intended for cemented fixation.

The Physica CR Knee Replacement System is a total knee replacement system consisting of a femoral component, a UHMWPE tibial liner, a tibial plate, and an all polyethylene patellar component. Modular tibial stems are provide for optional use as needed. The Physica CR knee system devices are intended to be used with bone cement.
The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.
The tibial plates and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).
Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.

The provided text describes a 510(k) premarket notification for a medical device, the Physica CR Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, much of the information typically associated with acceptance criteria and standalone studies for AI/software devices is not present.

Based on the document, here's what can be extracted and what is explicitly stated as not applicable:

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

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

This information is not applicable as no clinical or "test set" data in the context of AI/software performance is described. The "test set" mentioned in the document refers to mechanical testing of physical components. "Mechanical testing was performed on worst case components or constructs." No specific sample size for these mechanical tests is given. Data provenance is not mentioned beyond the manufacturer's location in Italy.

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

This is not applicable. The device is a physical knee prosthesis, not an AI/software device requiring expert-established ground truth for its performance assessment.

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

This is not applicable for the same reasons as point 3.

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

There was no MRMC comparative effectiveness study done. This is not an AI-assisted device.

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

A standalone performance evaluation in the context of an algorithm or AI was not done. This is a physical knee replacement system.

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

For the mechanical testing, the "ground truth" (or reference standard) is the established engineering and biomechanical principles and standards (e.g., ISO, ASTM) that govern the performance of such medical implants, and the performance of the legally marketed predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI/software system.

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

This is not applicable for the same reasons as point 8.

Study Proving Device Meets Acceptance Criteria

The study referenced in the document to prove the device meets acceptance criteria is a series of non-clinical mechanical tests. The document states:

• "The following tests were performed on Physica CR knee system devices: Contact areas and pressures at tibio-femoral and patello-femoral interfaces; Wear testing; Constraint tests at tibio-femoral and patello-femoral interfaces."
• "Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling, test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system."
• "Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions."

The basis for acceptance is demonstrating substantial equivalence to predicate devices (Physica KR, Vanguard, Scorpio) through these mechanical tests and by establishing that the new device shares the same materials, intended use, and basic design features as the predicates. No clinical testing was deemed necessary for this 510(k) submission.

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