Search Results

The Vitality Hip stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

It is intended to be used with cement with acetabular components or with unipolar, bipolar and CoCrMo femoral heads.

The Vitality Hip Stem is rectangular in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal half of the body of the femoral stem is grit blasted to a surface of 4-6 um. This device is fabricated from forged CoCrMo alloy.

The Foundation Vitality Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 130° for sizes 1-2 and 132° for sizes 3-6.

This document, K962560, is a 510(k) Premarket Notification for a medical device (Vitality Hip Stem), not a study evaluating software performance or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/software device is not applicable to this document.

The document describes a mechanical implant and its physical characteristics, indications for use, and comparison to predicate devices. The "Test Results" section refers to laboratory testing of a mechanical component (Morse type taper) and theoretical stress comparison, not clinical performance or diagnostic accuracy.

Here's a breakdown of why most of the requested information cannot be provided from this document, and what limited relevant information can be extracted:

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

• Not Applicable in the AI/Software Context: This document does not describe acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software.
• Limited "Acceptance" Information (Mechanical): The implied acceptance is that the mechanical testing (Morse taper and theoretical stress) demonstrated comparable or acceptable characteristics for a hip stem, allowing it to be considered substantially equivalent to predicate devices. The document states: "Theoretical testing of the maximum stresses was compared to the Foundation® 9 mm Forged Stem." This suggests the "acceptance criteria" for the stress comparison was likely not exceeding the stress levels, or performing comparably to, the predicate device.
  • Acceptance Criteria (Implicit Mechanical): Performance of Morse type taper and maximum stresses are comparable to or within acceptable limits relative to predicate devices (e.g., Foundation® 9 mm Forged Stem).
  • Reported Device Performance (Implicit Mechanical): Laboratory testing of the Morse type taper was conducted. Theoretical testing of the maximum stresses was compared to the Foundation® 9 mm Forged Stem (implying the comparison was successful and met whatever internal criteria for substantial equivalence). No quantitative performance values are provided in this summary.

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 pertains to a mechanical device. There is no "test set" in the context of diagnostic data, nor is there data provenance for clinical data. The "testing" refers to laboratory bench testing of physical components.

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: No ground truth in the diagnostic sense is established in this document.

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

• Not Applicable: No diagnostic test set or adjudication is described.

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 a mechanical device, not an AI/software device that would involve human readers.

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

• Not Applicable: This is a mechanical device, not an algorithm.

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

• Not Applicable: No ground truth in the diagnostic sense is established. The "truth" for mechanical testing would be engineering specifications and material properties.

8. The sample size for the training set

• Not Applicable: No AI/software training set is involved.

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

• Not Applicable: No AI/software training set is involved.

In summary, K962560 is a premarket notification for a physical hip implant. The "test results" mentioned refer to mechanical engineering tests, not clinical studies or AI/software performance evaluations. Therefore, the detailed questions about acceptance criteria, study design, expert involvement, and ground truth for AI/software are not relevant to this specific document.

Ask a specific question about this device