Search Results

VerSys Cemented Revision/Calcar is indicated for total hip arthroplasty in 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. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

The VerSys CRC Hip System includes femoral stems and build-up blocks that are permanent hip implants and provided sterile via gamma irradiation. The VerSys CRC Hip System include femoral stems in a variety of body sizes and lengths and build-up blocks in heights of 10mm, 20mm, and 30mm. The block is attached to the femoral stem by inserting two Tivanium® Ti-6Al-4V alloy screws into the holes provided. Only one build-up block can be attached to a femoral stem The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding bore of a femoral head.

This is a medical device 510(k) premarket notification and does not contain information on the acceptance criteria and study design for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence of a hip prosthesis (VerSys Cemented Revision/Calcar Hip System) to a legally marketed predicate device through non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

Ask a specific question about this device

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. An oblong insertion hole replaces the predicate round insertion hole in order to provide the surgeon with more control during insertion. For the new lateralized style, the difference in the two series lies in the horizontal offsets and neck angle. The offset is increased and therefore the distance from the center of the modular head to the center of the stem is also increased. The taper trunion or post is angled at 130° on the modified device whereas the post of the predicate device is at 135°.

This document describes a 510(k) premarket notification for the "X-Series Bi-Metric® Hip Femoral Components." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on performance studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or available in this document.

Here's an analysis based on the provided text:

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

This document does not provide a table of acceptance criteria as it would be understood for a new AI/medical device performance study. Instead, the "acceptance" in this context refers to the FDA's acceptance of the substantial equivalence claim. The performance relies on the device being "identical to or similar to" the predicate device.

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

Not applicable. This is a submission for a hip femoral component, not an AI or diagnostic device that would typically involve a test set of data. The "test" here refers to mechanical testing of the physical device.

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)

Not applicable. This document is about a physical medical device (hip implant), not a diagnostic algorithm. Therefore, there's no "ground truth" establishment in the context of image interpretation or diagnostic accuracy.

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

Not applicable. As there's no test set in the conventional sense for an AI/diagnostic device, no adjudication method was used.

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 a study involving human readers or AI assistance.

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

Not applicable. This device is a physical hip implant, not an algorithm.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is largely based on the established safety and performance of its predicate device, as well as mechanical testing.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable.

Summary derived from the document regarding "acceptance" for this device:

The "acceptance criteria" for the X-Series Bi-Metric® Hip Femoral Components, as evidenced in this 510(k) submission, revolved around demonstrating substantial equivalence to a legally marketed predicate device (Bi-Metric® Hip Femoral Component, K921224).

The "study" or evidence to prove this substantial equivalence included:

• Comparison of Device Description: The X-Series components are described as "identical to the predicate Bi-Metric® femoral components in overall geometry." Both are made from the same titanium alloy (Ti-6Al-4V). Stem diameters and lengths are identical.
• Minor Design Changes Justification: The only noted design changes are an "oblong insertion hole replaces the predicate round insertion hole" (to provide more surgeon control) and for the new lateralized style, differences in horizontal offsets and neck angle (130° vs. 135° taper trunion). The document argues these changes do not affect safety or effectiveness.
• Summary of Technologies: Stating that "The technological characteristics (materials, design, sizing and indications) of the X-Series Bi-Metric femoral components are similar to or identical to the predicate device."
• Non-Clinical Testing (Mechanical Testing): Mechanical testing was conducted "to insure the design changes would not effect the safety of the device." No specific results or acceptance criteria for this testing are provided in the summary, but its completion is noted as part of the submission package to FDA.
• Clinical Testing: "None provided" – indicating that clinical trials were not deemed necessary to demonstrate substantial equivalence for this device under the 510(k) pathway.

The FDA's letter (K020580) confirms that based on this information, the device was found substantially equivalent for its intended use, allowing it to proceed to market.

Ask a specific question about this device