Search Results

Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head. The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 24 mm, with increases of 2 mm, for a total of 6 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available. The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw. which also has a small pin made of UHMWPE (ISO 5834-2. ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting: proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

This document is an FDA 510(k) clearance letter for a medical device (Revision Femoral Stem). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. Therefore, it does not contain information about the performance of a device that relies on AI/ML or require extensive clinical efficacy studies typically needed for new technologies or those without clear predicates.

Consequently, I cannot provide the detailed information requested in the prompt, as the document explicitly states:

• "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate devices."

This means there's no data in this document for acceptance criteria related to AI/ML performance, no test set, no ground truth establishment, no human expert involvement for adjudication, no MRMC study, and no standalone algorithm performance.

The document discusses non-clinical testing such as fatigue testing and fretting evaluation, but these are for the mechanical properties of the hip implant itself, not for an AI/ML algorithm's performance.

If you have a document about an AI/ML medical device, I would be happy to analyze it against your criteria.

Ask a specific question about this device

The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

Like its predicates, the ZMR® Hip System-XL prosthesis is a modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal "body," a distal stem, and a compression nut.

The provided text describes a Special 510(k) for a device modification of the ZMR® Hip System-XL. The information primarily focuses on the device's regulatory approval based on its substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the typical sense of clinical or technical performance metrics.

Therefore, many of the requested elements for a comprehensive description of acceptance criteria and a study proving device performance (like specific performance metrics, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and detailed ground truth establishment) are not present in this regulatory document.

However, I can extract the available information and indicate where details are missing based on the document.

Acceptance Criteria and Device Performance

Based on the provided document, the "acceptance criteria" appear to be related to demonstrating substantial equivalence to predicate devices under the 510(k) pathway, specifically concerning safety and effectiveness. The "device performance" is primarily assessed through non-clinical testing to show this equivalence.

Study Details

Given the nature of this document (a 510(k) Summary of Safety and Effectiveness for a device modification), explicit details about a detailed study with specific performance metrics, sample sizes, and expert ground truth are not provided. The term "Performance Data" in this context refers to the non-clinical testing supporting substantial equivalence.

Here's what can be inferred or explicitly stated:

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

   • Not provided. The document states "Non-clinical performance testing," but does not detail the nature of this testing, the number of samples, or the data provenance. This typically refers to bench testing (e.g., mechanical, fatigue, wear) in a lab setting, not human subject data.

2. 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):

   • Not applicable/Not provided. For non-clinical performance testing of a hip prosthesis, "ground truth" as established by medical experts for diagnostic purposes (like radiologists) is not relevant. Performance is typically measured against engineering standards or predicate device specifications.

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

   • Not applicable/Not provided. Adjudication methods are typically associated with clinical trials or diagnostic accuracy studies involving human interpretation. For non-clinical performance testing, test results are usually objective and compared directly to pre-defined specification limits or predicate device results.

4. 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 is not relevant here. This is a hip prosthesis, not a diagnostic imaging device involving human readers or AI assistance in interpretation.

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

   • Not applicable. This is a hardware device (hip prosthesis), not an algorithm or software.

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

   • Not applicable in the medical expert sense. For non-clinical performance testing, the "ground truth" would be established engineering specifications, mechanical test standards (e.g., ISO or ASTM for implants), or direct comparison to the physical properties/performance of the predicate device. The document does not specify these details, only that "Non-clinical performance testing demonstrated that the device is equivalent to the predicate."

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not a machine learning model, so there is no training set.

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

Ask a specific question about this device