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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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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

The Contoured Articular Prosthetic (CAP) consists of two components, a taper post component and an articular 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 taper post component is manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The taper post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore. The taper post is available in a 25mm and 30mm length to provide for variation in humeral head size.

The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

Utilizing the drill guide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the taper post is driven into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the taper post. With these offset measurements, the surgeon is able to select the articular component from a range of sizes that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage.

A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.

The provided text describes a 510(k) summary for a medical device called the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and study results for device performance in the way that would typically be seen for a new AI/software device.

Therefore, the requested information elements related to AI device evaluation (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of medical device submission.

Here's an attempt to answer the prompt based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" or report detailed "device performance" metrics as would be typically expected for a diagnostic or AI device. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, materials, and application. The "performance" is implicitly tied to meeting the functional requirements of a humeral head resurfacing prosthesis and being similar to legally marketed devices.

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

Not applicable. This is a physical orthopedic implant. There is no "test set" in the context of an AI algorithm or diagnostic device. The evaluation is based on engineering design, material properties, and comparison to predicate devices, not data analysis of a test set.

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

Not applicable. There is no "ground truth" establishment in the context of a diagnostic test set for this physical implant. The design and manufacturing process adhere to recognized standards and are reviewed for substantial equivalence by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" for which adjudication would be required.

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 physical medical implant, not an AI or diagnostic tool 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 physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic dataset. The "ground truth" for the device's safety and effectiveness relies on:

• Adherence to established material standards (e.g., ASTM F136, F799, F1537).
• Predicate device history of safe and effective use.
• Engineering principles and mechanical testing (though specific results are not detailed in this summary, they would be part of the full submission).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical implant.

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

Not applicable. There is no "training set" for this physical implant.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented in this 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices. The core argument is that the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System has:

• Identical Intended Use: Reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis, with similar requirements for bone stock and rotator cuff integrity.
• Similar Materials: The components are made from Ti-6Al-4V ELI alloy and Cobalt-Chromium-Molybdenum alloy, with a CP Titanium coating – materials commonly used and accepted for orthopedic implants.
• Similar Application/Technology: The device's design, including a taper interlock system, drill guide for axis definition, and selection of articular components for optimal fit, is presented as technically similar to predicates. The claims of "minimal bone resection" and flexibility in sizing and fitting are implied to be performance characteristics that align with or improve upon predicate devices.
• Established Safety Profile: The potential associated risks are explicitly stated to be the same as those associated with other joint prosthetic devices, implying no new or elevated risks compared to the predicates.

The FDA's letter (K023096) confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This determination signifies that the device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance metrics against specific acceptance thresholds as would be done for novel technologies or AI.

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