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The Ascension® HRA® System TPS/HA is intended for resurfacing of the humeral head due to:

• Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis).
• Mild or moderate humeral head deformity and / or limited motion.
• Post-traumatic arthritis.
• Patients with an intact or reparable rotator cuff.

The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for noncemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium or HA plasma spray undersurface and stem coating for osseointegration. No new materials are introduced with this device. Ascension® HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.

The provided document is a 510(k) summary for the Ascension® HRA® System TPS/HA, a medical device for humeral head resurfacing. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies in the way a diagnostic AI device might.

Therefore, many of the requested categories related to AI device evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract the information that is relevant to the "acceptance criteria" (which in this context refers to the characteristics that demonstrate substantial equivalence) and the "study" (which is the comparison to predicate devices) as presented in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission, "acceptance criteria" are the features and characteristics that the new device must meet to be considered substantially equivalent to the predicate devices. The "reported device performance" is how the new device measures up against these criteria, often shown by direct comparison to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size used for the test set: Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the context of AI or diagnostic device evaluation. The "test set" here would refer to the characteristics and materials of the device itself and its comparison to legally marketed predicate devices.
• Data provenance: Not applicable in the traditional sense of patient data. The "data" here comes from a comparison of design specifications, materials, and intended use as documented for the submitted device and previously cleared predicate devices (Biomet Coneland Humeral Resurfacing Head K010664, K010827 and K051843; DePuy Global C.A.P. K031971 and K033516; Ascension® Humeral Resurfacing Arthroplasty (HRA) System K062861). The study is a retrospective comparison of existing device specifications and regulatory clearances. The origin is the specifications of the devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no "ground truth" established by experts for a test set in the context of this 510(k) submission. The ground truth, in a sense, is the regulatory acceptance of the predicate devices and the documented specifications of all devices.

4. Adjudication method for the test set

• Not applicable. No adjudication method was used, as there was no test set or expert assessment of outcomes.

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 not an AI or diagnostic imaging device, so MRMC studies are not relevant.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• The "ground truth" for this 510(k) is the established regulatory acceptance and performance specifications of the predicate devices. The new device demonstrates "substantial equivalence" to these established benchmarks.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning device and therefore does not have a training set.

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

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

In summary, this 510(k) submission demonstrates that the Ascension® HRA® System TPS/HA is substantially equivalent to legally marketed predicate devices by comparing its design, materials, and intended use. The "study" is a feature-by-feature comparison, and the "acceptance criteria" are derived from the characteristics of the predicate devices. It is crucial to understand that this type of submission follows a different regulatory pathway than, for instance, an AI-powered diagnostic device, and thus many of the questions are not applicable to the information provided.

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