Search Results

The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

Indications:

• Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
• Rheumatoid arthritis, .
• Correction of functional deformity, .
• Revision procedures where other treatments or devices have failed, .
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This Special 510(k) covers a modified Exeter Hip System which differs from the existing, predicate Exeter Hip System primarily in that it features a different trunnion known as the V40™ Taper. In addition to the change in Exeter Hip Stems and Heads from the predicate trunnion design to the newer V40™ Taper, this submission includes some additional stem and head sizes, the addition of an insertion dimple on the stems, reduction in stem neck diameter, and a new wingless version of the stem centralizer component.

The original document is a 510(k) Premarket Notification for a medical device: the Modified Exeter Hip System with V40™ Taper. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating novel clinical efficacy through extensive clinical trials. Therefore, much of the requested information regarding clinical study design (sample sizes, expert qualifications, adjudication, MRMC studies, training set details) is not applicable or available in this type of regulatory submission. The focus is on engineering and mechanical testing to ensure safety and function.

Here's the information extracted from the provided text, with clarifications where the requested detail is not present in a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified in the document. This typically refers to the number of devices or components tested, which would be governed by the specific ISO standards.
• Data Provenance: Not specified. This documentation relates to mechanical testing, not clinical data provenance. Given the nature of a 510(k) and the testing standards, this would be laboratory testing.

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. For mechanical testing of medical devices, "ground truth" as it pertains to expert interpretation of clinical data is not a concept. The "ground truth" is adherence to the mechanical performance specifications set by the ISO standards. The evaluation is against these predefined engineering criteria, not expert consensus on medical images or patient outcomes.

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

• Not Applicable. Adjudication methods are relevant for clinical trials where there's variability in interpretation (e.g., image reading). Mechanical testing relies on objective measurements against pre-defined engineering standards; therefore, an adjudication method for test data is not relevant here.

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. This is a mechanical device, not an AI-powered diagnostic tool. MRMC studies are not relevant for this type of device.

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

• Not Applicable. This is a mechanical hip implant, not an algorithm or software device.

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

• Mechanical Standards: The "ground truth" for this device's performance testing is adherence to the specifications and performance requirements outlined in the referenced ISO standards (ISO 7206-4 and 7206-6). For the Zirconia V40™ Femoral Heads, the 'ground truth' was their "suitability for use" with the subject hip stems, implying compatibility and performance within acceptable limits as determined by testing.

8. The sample size for the training set

• Not Applicable. This is a mechanical hip implant, not a machine learning model requiring a training set.

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

• Not Applicable. (See #8)

Ask a specific question about this device