(68 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, rolar Nrece components in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, computible intire and designed stabilized knee systems are designed for use in patients in or tolarwiso replacement. primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).
The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components which accommodate The Profix Flex Cruciate Relaining Antoclarines in Subscribers of Series flexion range. The greater lies on to those patiente with his and patellar components of the Profix Total Knee System cleared via K933958 (cemented use) and K030623 (uncemented use).
The provided text describes a medical device, the Profix Flex Cruciate Retaining Articular Insert, and its clearance process. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of human or AI-assisted diagnostic performance.
Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and a comparison of design features, operational principles, and material composition.
Therefore, many of the requested sections about acceptance criteria and studies are not applicable to the provided document.
Here's an analysis based on the information provided:
Acceptance Criteria and Study for Profix Flex Cruciate Retaining Articular Insert
The provided 510(k) summary does not contain information about acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) or a study evaluating such criteria. The document pertains to a medical implant and its mechanical and design equivalence, not a diagnostic or AI device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (N/A for this device type) | Reported Device Performance (N/A for this device type) |
|---|---|
| Diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) | No diagnostic performance metrics reported. |
| Clinical outcomes based on human or AI-assisted interpretation | No clinical outcomes based on human or AI-assisted interpretation reported. |
| Mechanical Test Data (General Statement) | "Mechanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is comparable to similar devices currently used clinically and is capable of withstanding expected in vivo loading without failure." |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. The document does not describe a clinical test set in the context of diagnostic performance or AI evaluation. The "mechanical test data" mentioned is not given with sample sizes or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No expert ground truth establishment for a diagnostic test set is mentioned.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method for a diagnostic test set is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This type of study is irrelevant to the device described (an orthopedic implant).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. The document does not describe any algorithm-only performance study. This is irrelevant to the described device.
7. Type of Ground Truth Used:
- Not applicable. No ground truth for diagnostic or AI performance is mentioned. The primary "truth" evaluated is substantial equivalence to predicate devices based on design, materials, and intended use, supported by mechanical testing results.
8. Sample Size for the Training Set:
- Not applicable. The document does not refer to a "training set" as it is not for an AI or diagnostic application.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI or diagnostic application, no ground truth establishment method is mentioned.
Summary of what the document does provide:
- Device Description: The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components for the Profix Total Knee System.
- Intended Use: For use in patients with rheumatoid arthritis, post-traumatic arthritis, failed osteotomies, unicompartmental replacement, or total knee replacement, especially where anterior and posterior cruciate ligaments are absent or incompetent, but collateral ligaments are intact.
- Substantial Equivalence: The device's equivalence is based on similarities in indications for use, design features, operational principles, and material composition to existing predicate devices (K933958, K030623, K041825).
- Mechanical Data: There's a general statement that "Mechanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is comparable to similar devices currently used clinically and is capable of withstanding expected in vivo loading without failure." No specific data, sample sizes, or acceptance criteria for this mechanical testing are detailed in the summary.
§ 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.