(65 days)
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.
Additional indications for Physica LMC component are:
- · Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:
· Iigamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);
· absent or not-functioning posterior cruciate ligament.
Physica LMC knee system is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can optionally be used with the Physica LMC knee system. The Physica LMC knee system components are intended to be used with bone cement.
The provided text describes a 510(k) premarket notification for the "Physica LMC Knee System." This document is a regulatory submission for a medical device and does not detail an AI/ML study with acceptance criteria, human reader performance, or ground truth establishment in the way typically associated with diagnostic algorithms.
The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and non-clinical mechanical testing.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and AI/ML specific metrics cannot be found in this document.
Here's what can be extracted based on the provided text, with clarifications where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Testing | Substantially equivalent to predicate devices in: | "Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices" |
| - Contact area / pressure at the femoral component and tibial liner coupling (FDA guideline, ASTM F2083) | (Specific quantitative results not provided, only statement of equivalence) | |
| - Wear of the articulating surfaces (ISO 14243) | (Specific quantitative results not provided, only statement of equivalence) | |
| - Constraint of the femoral component and tibial liner coupling (FDA guideline, ASTM F1223) | (Specific quantitative results not provided, only statement of equivalence) | |
| Clinical Performance | (Not applicable; clinical testing was not deemed necessary for this 510(k) submission to demonstrate substantial equivalence.) | "Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica LMC knee system to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document describes mechanical testing, not a diagnostic algorithm's performance on a test set of data. The "test set" in this context refers to the physical devices undergoing mechanical tests, not medical imaging or clinical data.
- Data Provenance: Not applicable in the context of an AI/ML diagnostic study. The testing described is mechanical, involving physical components of the knee system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for diagnostic AI/ML (e.g., expert consensus on image interpretation, pathology reports) is not relevant to the mechanical testing described. The "ground truth" for mechanical testing would be defined by engineering standards and measurement techniques applied by qualified engineers or technicians, but the document does not specify their number or qualifications.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in diagnostic studies. This document discusses mechanical engineering tests, where results are typically objective measurements against standards.
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. An MRMC study was not done. This submission is for a knee implant, not a diagnostic AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone algorithm performance study was not done. This submission is for a knee implant, not a diagnostic AI/ML device.
7. The type of ground truth used
- The "ground truth" for the mechanical testing would be established by validated engineering methodologies and standards (e.g., ASTM F2083, ISO 14243, ASTM F1223) that define acceptable performance parameters for knee implants. This is distinct from ground truth in diagnostic AI/ML, which typically refers to clinical outcomes, pathology, or expert consensus on interpretations.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this document does not describe the development or evaluation of an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set or its ground truth.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.