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The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:

• · Pain and weakness of the wrist joint not improved by non-operative treatment
• · Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radio ulnar joint
• · Failed ulnar head resection; e.g. Darrach resection
• · Primary replacement after fracture of the ulnar head or neck.
• · Revision following failed ulnar head arthroplasty.

This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for the Aptis Medical Distal Radio Ulnar Joint Implant. The key information provided relates to its substantial equivalence to a predicate device, regulatory classifications, and indications for use.

Specifically, Section VII, "Performance Data," states: "Evaluation in the MRI environment of the subject device was performed through computational modeling and simulation of radiofrequency induced heating. No clinical data was submitted to support substantial equivalence." This explicitly indicates that a study demonstrating device performance against acceptance criteria, particularly clinical performance, was not conducted or submitted for this specific premarket notification.

Therefore, I cannot extract the requested information from the provided text.

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The Aptis Medical Distal Radio Ulnar Joint implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

• Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
  • Pain and weakness of the wrist joint not improved by non-operative treatment
  • Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
  • Failed ulnar head resection; e.g. Darrach resection
• Primary replacement after fracture of the ulnar head or neck.
• Revision following failed ulnar head arthroplasty.

This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including; Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head. The device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna.

The provided document is a 510(k) premarket notification for the Aptis Medical Distal Radio Ulnar Joint Implant. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study that measures performance against those criteria.

Therefore, the document does not contain the information requested in categories 1-6 and 8-9 regarding acceptance criteria, study details, sample sizes, expert involvement, or multi-reader studies.

However, it does provide information partially relevant to category 7, which is about the type of ground truth used.

Here's a breakdown based on the categories provided, explaining why certain information is absent:

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

• Information not provided. The document describes a medical implant seeking substantial equivalence, not an AI/software device with performance metrics like sensitivity or specificity. The "performance" discussed is related to mechanical testing, not diagnostic or predictive accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Information not provided. No clinical test set or data provenance is mentioned. The "performance data" refers to mechanical testing of the implant itself, not a test set of patient data.

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)

• Information not provided. Since no clinical test set or diagnostic ground truth establishing is discussed, there is no mention of experts for this purpose.

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

• Information not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not applicable here as no clinical test set 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

• Information not provided. This device is a physical implant, not an AI or software component, so an MRMC study related to AI assistance is irrelevant.

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

• Information not provided. As mentioned, this is a physical medical device, not an algorithm.

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

• The document describes mechanical testing as the basis for performance evaluation. The "ground truth" in this context would be the physical properties and mechanical integrity of the implant when subjected to various forces (static compression, static tension, dynamic compression). The comparison is against the predicate device's mechanical performance, establishing "comparable loads under similar test conditions."

8. The sample size for the training set

• Information not provided. This concept is only applicable to machine learning models, not physical implants.

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

• Information not provided. This concept is only applicable to machine learning models, not physical implants.

In summary, the document concerns the regulatory approval of a physical medical implant based on substantial equivalence to a predicate device, primarily through mechanical performance data. It does not involve AI or software, and therefore lacks the detailed information on clinical study design, acceptance criteria, and ground truth establishment typically found in submissions for such devices.

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Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

• Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
  • Pain and weakness of the wrist joint not improved by non-operative treatment
  • Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
  • Failed ulnar head resection; eg. Darrach resection
• Primary replacement after fracture of the ulnar head or neck.
• Revision following failed ulnar head arthroplasty.

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

This 510(k) summary describes a medical device, the Aptis Medical Distal Radio-Ulnar Joint Implant, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be presented for an AI/ML powered device.

The provided text describes a "Predicate Device" submission, which is a regulatory pathway for demonstrating that a new device is as safe and effective as a legally marketed predicate device. In essence, the "study" is a comparison to the predicate device, not a trial demonstrating novel performance or specific acceptance criteria for an AI model.

Here's an analysis based on the information provided, framed to address your questions where applicable, and noting where the requested information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is a 510(k) Pre-Market Notification for a medical device (Distal Radio-Ulnar Joint Implant), not an AI/ML-powered device. Therefore, the concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" for algorithmic performance (e.g., accuracy, sensitivity, specificity) does not directly apply in the usual sense for this type of medical device submission.

Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously legally marketed device (the predicate device). The "study" in this context is the comparison of the new device's characteristics against the predicate device's characteristics. The goal is to show that the new device has the same intended use and similar technological characteristics to the predicate device, or that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a predicate device comparison, typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The "acceptance criteria" are based on demonstrating substantial equivalence, and "performance" is implicitly tied to matching the predicate device.

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

There is no "test set" in the context of an AI/ML algorithm evaluation mentioned in this document. The "study" for this submission is a comparative analysis of the device's design, materials, and intended use against a predicate device. This process does not involve a sample size of patient data or algorithm outputs.

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

Not applicable. This is not an AI/ML evaluation requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable.

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-assisted device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

For this type of device submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate device, as determined by its prior FDA clearance. The new device is compared against this established benchmark.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for the device design would be based on engineering principles and knowledge of orthopedic surgery.

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

Not applicable. As there's no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this submission.

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Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

• Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
• Pain and weakness of the wrist joint not improved by non-operative treatment .
• Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint
• Failed ulnar head resection; eg. Darrach resection .
• Primary replacement after fracture of the ulnar head or neck. .
• Revision following failed ulnar head arthroplasty. .

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

The provided document is a 510(k) summary for a medical device (Wrist joint ulnar (hemi-wrist) prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Here's a breakdown of why the requested information cannot be fully provided based solely on the input, and what can be inferred or stated about the nature of this submission:

This 510(k) submission is for an expanded product line (additional stem lengths and diameters) of an already existing, legally marketed predicate device (the Aptis Medical Distal Radio-Ulnar Joint Implant). The focus of such a submission is usually to demonstrate that the new sizes do not introduce new questions of safety or effectiveness compared to the predicate. This often relies on comparative analysis, materials testing, and mechanical testing, rather than clinical efficacy studies with ground truth.

Given this context, here's an attempt to address your points, explaining where information is absent:

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

This information is not present in the provided 510(k) summary. A 510(k) for a device like this, especially for additional sizes of an existing product, typically relies on comparison to a predicate device and engineering/bench testing rather than clinical performance criteria (like sensitivity/specificity or other metrics for diagnostic/AI devices). If any specific performance criteria were used (e.g., maximum stress, fatigue life), they are not disclosed in this summary document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of a 510(k) for an orthopedic implant and is not present in the document. There is no mention of a "test set" in the sense of patient data for evaluating performance against ground truth. The "test" in this context would likely refer to mechanical or materials testing, for which sample sizes are not provided in this summary.

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)

This is not applicable and not present. Ground truth, expert consensus, or clinical adjudication by experts are typically relevant for diagnostic devices or AI algorithms that interpret medical data. This document describes a surgical implant.

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

This is not applicable and not present for the same reasons as point 3.

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

This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or data, often in conjunction with AI. This document pertains to a medical implant.

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

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

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

This is not applicable for this type of device and submission. The "ground truth" for an orthopedic implant is generally its mechanical integrity, biocompatibility, and clinical outcomes over time, which are usually assessed through a combination of engineering tests, pre-clinical studies, and post-market surveillance for established devices. No specific "ground truth" data is detailed in this summary.

8. The sample size for the training set

This is not applicable and not present. There is no "training set" as this is not an AI/ML device.

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

This is not applicable and not present for the same reasons as point 8.

Summary of the Study (as described in the 510(k) summary):

The "study" or justification for substantial equivalence in this 510(k) involves a comparative analysis of the proposed device (Aptis Medical Distal Radio-Ulnar Joint Implant with additional stem lengths and diameters) to its legally marketed predicate device (the original Aptis Medical Distal Radio-Ulnar Joint Implant).

The document states:

• "The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant"
• "Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters."
• The comparison table highlights similarities in product name, use, fixation, constraint, material, and crucially, identical indications for use.
• The summary explicitly notes: "Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical indications for use."
• "The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device."

Conclusion:

This 510(k) summary provides a justification for substantial equivalence based on the similarity in design, materials, and intended use between the new device (additional sizes) and its existing predicate. It primarily relies on demonstrating that the changes are minor and do not alter the safety or effectiveness profile as established by the predicate device. It does not describe a clinical performance study with acceptance criteria, ground truth, or expert evaluation typically associated with diagnostic or AI-driven devices.

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Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

• Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
• Pain and weakness of the wrist joint not improved by non-operative treatment
• Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
• Failed ulnar head resection; eg. Darrach resection
• Primary replacement after fracture of the ulnar head or neck.
• Revision following failed ulnar head arthroplasty.

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

This 510(k) summary describes a medical device, the Aptis Medical Distal Radio-Ulnar Joint Implant, seeking substantial equivalence to a predicate device. As such, the documentation provided does not include acceptance criteria for standalone device performance, nor details of a study demonstrating such performance in the way a clinical trial for a novel AI device would.

Instead, the "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The study proving this involves a comparison of design characteristics and intended use.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) submission for a medical implant, not an AI/software device. Therefore, the concept of a "test set" in the context of machine learning (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here. The "test" is a comparison of the device's characteristics and intended use against a legally marketed predicate device.

• Test Set Sample Size: Not applicable in the context of an AI device's performance evaluation. The "sample" here refers to the characteristics of the device itself and its comparison to the predicate.
• Data Provenance: Not applicable for an AI device. The "data" are the specifications and indications for use of the proposed and predicate devices.

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

• Number of Experts: Not applicable. "Ground truth" in an AI/imaging context refers to definitive labels or diagnoses. For a device like this, the "ground truth" is established by regulatory standards, engineering specifications, and clinical consensus on indications for use.
• Qualifications of Experts: The review was conducted by the FDA, specifically the Division of General, Restorative and Neurological Devices at the Office of Device Evaluation, Center for Devices and Radiological Health. The Director at the time was Celia M. Witten, Ph.D., M.D. This implies review by medical and regulatory experts involved in orthopedic devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of an AI device's performance evaluation. The "adjudication" in this regulatory context is the FDA's decision-making process based on the submitted application and comparison to the predicate device.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical implant like a joint prosthesis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: No, a standalone study was not done. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the FDA's regulatory framework and the established safety and effectiveness of the legally marketed predicate device. This involves:
  • Predicate Device's Known Performance: The WMT Modular Ulnar Head, having been legally marketed, is accepted as safe and effective for its indicated uses.
  • Engineering Standards and Biocompatibility Data: Although not explicitly detailed in the summary, implantable devices are subject to rigorous testing against international and national standards for materials, mechanical properties, and biocompatibility. The "industry standard materials" and the comparison of fixation methods suggest adherence to these established engineering principles.
  • Clinical Consensus on Indications for Use: The listed indications are based on established medical practice for orthopedic surgery.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.

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