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Hemi-Arthroplasty Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant incorporates an articular resurfacing component and a cancellous taper post component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The provided text describes a 510(k) summary for the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant. It details the device's intended use, description, materials, and claims of substantial equivalency to previously cleared devices.

Based on the provided information, the following points can be made regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific, quantifiable acceptance criteria in the traditional sense (e.g., a minimum accuracy, sensitivity, or specificity value). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it is found to be substantially equivalent.

Therefore, a table of acceptance criteria and reported device performance cannot be directly extracted from the provided text in the requested format. The document focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document states, "Clinical data was provided in support of the substantial equivalency. Data was obtained from over 100 patients with follow-up ranging out to 5 years." This "over 100 patients" represents the size of the clinical dataset used to support the substantial equivalency claim, which can be considered the "test set" in this context.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given that it refers to "follow-up ranging out to 5 years," it implies that the data collected over time rather than just at a single point, but the exact study design (retrospective or prospective) is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The text focuses on the device itself and its comparison to predicates, not on the methodology of expert review or ground truth establishment. Clinical outcomes from the "over 100 patients" likely formed the basis for evaluating the device's performance, but how these outcomes were assessed or validated by experts is not described.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

This type of study was not conducted for this device submission. The submission relies on demonstrating substantial equivalence to predicate devices based on clinical data from over 100 patients. There is no mention of human readers, AI assistance, or comparative effectiveness in the context of an MRMC study. This device is a physical implant, not a diagnostic or AI-powered tool that would typically undergo such a study.

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

This is not applicable as the device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the assessment of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant would be the clinical outcomes and performance observed in "over 100 patients with follow-up ranging out to 5 years." This would include measures of pain relief, stability, restoration of function, and absence of adverse events, assessed by medical professionals in a clinical setting related to the treatment of degenerative and post-traumatic arthritis in the metatarsal joint. The document does not specify if pathology or other objective measures were exclusively used.

8. The Sample Size for the Training Set:

This information is not applicable in this context. This device is a physical implant, and the submission is based on clinical data and substantial equivalence to predicates, not on a machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no "training set" for a machine learning model.

In summary, the core of this submission is demonstrating "substantial equivalency" to existing, legally marketed predicate devices, rather than meeting specific quantitative acceptance criteria through a de novo clinical trial with defined endpoints and ground truth adjudication by experts in the context of a new diagnostic or AI device. The "study" mentioned is the collection of clinical data from "over 100 patients" to support this claim of substantial equivalency.

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