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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 Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.

Indications For Use:

• I. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation. Non-coated (Interlok") femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.

• Where Available

The purpose of the submission is to update the locking mechanism cleared in K122160.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of El poly. Biomet® patellae can be used with the Vanguard XP Knee System. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.

The Vanguard™ XP Knee System is made up of multiple components. including: instrumentation, femoral components, several types of bearings and tibial trays.

The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, and K113550) in terms of design. material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of K122160 and subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Nonclinical) section.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Vanguard™ XP Knee System:

Device: Biomet Vanguard™ XP Knee System

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K132873) focuses on a modification to the locking mechanism of an already cleared knee system. As such, the acceptance criteria are not explicitly numerical performance targets in the sense of a new device's efficacy, but rather a demonstration that the modification does not adversely affect safety and maintains substantial equivalence to predicate devices. The "reported device performance" is essentially that all tests met or exceeded established acceptance criteria, confirming this non-adverse effect.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of components tested) for each non-clinical test. It only states that the tests were performed.
• Data Provenance: The data is from non-clinical testing (mechanical tests). The origin country is not explicitly stated, but given the submitter and FDA context, it is presumed to be conducted under standards relevant to the US market. The nature of the study is purely retrospective in the sense that it's testing a modified device against established standards and predicate data, not a de novo prospective clinical trial.

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

Not applicable. This submission relies on non-clinical mechanical testing, not expert-reviewed clinical data or images. The "ground truth" for these tests is the performance against pre-defined engineering and mechanical standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is non-clinical mechanical testing, not a clinical study involving human readers or adjudication. The results are quantitative measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document explicitly states: "No clinical testing was necessary for a determination of substantial equivalence." Therefore, no MRMC study was conducted. The nature of this submission is a modification to a previously cleared device, relying on non-clinical testing to demonstrate that the modification does not introduce new safety or effectiveness concerns.

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

No. This is a physical prosthetic device (a knee system), not an algorithm or AI-based device. "Standalone performance" in this context would refer to the mechanical performance of the device components themselves, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Pre-defined engineering standards and mechanical test protocols (e.g., for fatigue, stability, locking mechanism integrity).
• Performance data from legally marketed predicate devices (K122160, K113550, K904448), to which substantial equivalence is claimed.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing processes and design principles are based on established engineering practices and predicate devices.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set." The design and manufacturing of the device were established through conventional engineering and medical device development processes, drawing upon existing knowledge, materials science, and the performance characteristics of predicate devices.

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For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.

OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.

The provided text is a 510(k) summary for the OrthoSensor VERASENSE™ Knee System, which describes a modification to an existing device. It focuses on regulatory approval for labeling changes and physical modifications to allow compatibility with another knee system.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance or effectiveness in the way an AI/ML device would be evaluated (e.g., accuracy, sensitivity, specificity).

The document states:

"The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device."

This indicates that the modified device was tested against the same performance criteria as the original predicate device, not that a new study was conducted to establish new acceptance criteria or to prove clinical effectiveness of the device's intended use (reducing instability from flexion gap asymmetry). The changes are primarily related to mechanical compatibility and labeling.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert involvement, or MRMC studies for this specific submission, because that information is not present in the provided text.

The document discusses:

• Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.
• Device Description: An instrumented trial tibial insert with load sensors and angular positional information.
• Changes: Modification to package label to reflect use with Biomet Vanguard Knee System, changes to device surface contours and dimensions specific to the Biomet Vanguard Knee System, and addition of a new color of Polycarbonate.
• Design Control Activities: The modifications were evaluated under design controls and "met the same performance criteria as the predicate device."
• Substantial Equivalence: The submission claims substantial equivalence to the predicate device, stating it has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness.

In summary, the provided text does not contain the specific information required to answer the prompt regarding acceptance criteria and performance study details for an AI/ML device.

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