Search Results

The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteonics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Head. The devices continue to be compatible with the predicate distal ring centralizers. The femoral stem is intended for cemented fixation.

Indications:

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

The subject Accolade™ C Femoral Stems are forged from cobalt chromium alloy. They are straight, neutral stems with medial collars. They come in 127° and 132° neck angles. Crescent shaped indentations on the anterior and posterior surfaces provide rotational stability and enhanced mechanical interlock of the cement. The lateral shoulder features a non-threaded hole for connection to an insertion tool. The distal tip of the stems features a recess for optional use with a cement spacer.

The subject Accolade™ C Femoral Stems differ from the predicate Accolade™ C Femoral Stems only in that they feature a recess in the distal tip to allow use with the predicate Howmedica Osteonics Universal Distal Spacers or Universal Distal Hole Plugs. All other design features, materials, and intended uses are the same as for the predicate Accolade™ C Femoral Stems.

The provided text describes a Special 510(k) submission for a modification to an existing medical device, the Accolade™ C Femoral Stems. This process focuses on demonstrating that the modified device is substantially equivalent to the predicate device, not on proving de novo performance against acceptance criteria for a new, unproven technology.

Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating the performance of new or significantly changed devices, is largely not applicable in the context of this Special 510(k) submission.

Here's an explanation based on the provided document:

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

• Not Applicable in the traditional sense. For a Special 510(k), the primary "acceptance criterion" is proving substantial equivalence to the predicate device, especially regarding safety and effectiveness.
• Reported Device Performance: The primary "performance" reported is the outcome of a stress analysis.
  • Acceptance Criteria (Implied): The incorporation of a distal recess "does not adversely affect the integrity of the subject devices."
  • Reported Device Performance: "Analysis of stresses in the subject hip stems was performed to ensure that the incorporation of a distal recess does not adversely affect the integrity of the subject devices." This statement implies that the analysis confirmed that the integrity was not adversely affected, thereby meeting the implied criterion.

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. The study involved a "stress analysis," which typically refers to engineering simulations (e.g., Finite Element Analysis) or mechanical testing on physical prototypes, not clinical trials with human subjects. Therefore, concepts like "sample size for a test set" or "data provenance" in the clinical sense do not apply.

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 stress analysis, "ground truth" is established through engineering principles, material science, and possibly recognized testing standards. It doesn't involve clinical expert consensus. The "experts" would be engineers or biomechanical specialists conducting the analysis.

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

• Not Applicable. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions on outcomes or diagnoses. This was a technical stress analysis.

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 device is a femoral stem, not an AI-assisted diagnostic tool. MRMC studies are completely irrelevant to this submission.

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

• Not Applicable. As mentioned, this is not an AI algorithm.

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

• For the stress analysis, the "ground truth" would be the physical and mechanical properties of the cobalt chromium alloy and the design's structural integrity under simulated physiological loads, as determined by engineering principles, material testing standards (e.g., ASTM, ISO), and potentially computational modeling results validated against known biomechanical data.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of mechanical stress analysis for a medical implant modification.

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

• Not Applicable. (See point 8)

In summary: The provided document is for a medical device (hip implant) modification that underwent a Special 510(k) pathway. The primary evidence presented is a stress analysis to ensure the modified design's integrity. Concepts related to AI, clinical trials, and general acceptance criteria for novel devices are not relevant to this specific submission.

Ask a specific question about this device