Search Results

The Ovation Tribute and Ovation Narrow Hip Stems are intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

Indications for Use:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

The provided document is a 510(k) summary for the Ovation Tribute and Ovation Narrow Hip Stems. It describes the device, its intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

This document describes a hip stem prosthesis, which is a physical implant, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance (like accuracy, sensitivity, specificity, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "study" mentioned in the document is non-clinical performance testing conducted on the physical hip stems, not a study of an AI/ML algorithm's effectiveness.

Here's a breakdown of the relevant information from the document, recognizing that it's for a physical device:

K133386 - Ovation Tribute Hip Stem; Ovation Narrow Hip Stem

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document states that "Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis." The specific numerical acceptance criteria and detailed performance results are not provided in this summary, but are implicitly met by "in accordance with" and "underwent testing for".

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 submission is for a physical medical device (hip stem), not an AI/ML device that uses digital data for testing. The "test set" refers to physical samples of the hip stems subjected to mechanical testing. The sample size for these non-clinical mechanical tests is not specified in this summary.

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. Ground truth, in the context of AI/ML, refers to human-labeled data. For a physical device, testing against international standards does not involve expert adjudication of "ground truth" in the same way. The standards themselves define the criteria.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling for AI/ML ground truth. This is not pertinent to mechanical testing of a physical device.

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. MRMC studies are used to evaluate diagnostic imaging devices, often with AI assistance. This submission is for a hip stem implant.

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

• Not applicable. This question pertains to AI/ML algorithm performance.

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

• Not applicable. For this physical device, the "ground truth" for its performance is determined by established engineering principles and international standards (ISO standards for mechanical testing).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a physical hip stem being submitted under 510(k). This term is exclusive to machine learning.

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

• Not applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device