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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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The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.

The First Choice Partial Ulnar Head implant is intended for press-fit use.

The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.

Here's an analysis of the provided text regarding the "First Choice Partial Ulnar Head Implant" and how it addresses the requested information about acceptance criteria and supporting studies:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting new acceptance criteria through a clinical study. Therefore, many of the requested categories related to independent clinical studies with specific performance metrics will not be directly applicable or present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

• Ulnar Head Biomechanics testing.
• DRUJ Stem Bend Strength testing.
  (Specific quantitative acceptance thresholds for these tests are not provided in this summary, but the implicit acceptance criterion is that the results fall within limits demonstrating equivalence to the predicate.) |
  | Clinical Performance: | Clinical Performance: |
  | Not necessary to support substantial equivalence. | Clinical performance data were not necessary to support substantial equivalence. |

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

• Sample Size for Test Set: Not applicable. No clinical test set. The non-clinical tests were conducted on prototypes of the new device and, by inference, compared to design specifications or performance characteristics of the predicate device. The document does not specify the number of units tested.
• Data Provenance: Not applicable. The testing described is non-clinical (biomechanical), likely conducted in a lab setting by the manufacturer, Ascension Orthopedics.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established engineering and biomechanical principles and potentially the performance data of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

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 physical orthopedic implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-assisted reading are irrelevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Non-Clinical: The implicit "ground truth" for the non-clinical performance data (Ulnar Head Biomechanics and DRUJ Stem Bend Strength) is the established engineering and biomechanical performance characteristics considered acceptable for the device's function, and, critically, the performance of the predicate device (Ascension® Modular Ulnar Head, K052137). The goal was to prove substantial equivalence, meaning the new device performs at least as well as the legally marketed predicate.
• Clinical: Not applicable, as clinical data was deemed unnecessary for this 510(k) submission.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device that requires a training set.

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

• Not applicable. As noted above, this is not an AI or machine learning device.

Explanation of the Study and Why it Meets "Acceptance Criteria"

The "study" in this context is the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, not an efficacy or safety study to meet specific, pre-defined acceptance criteria for a novel device.

• Device: First Choice Partial Ulnar Head Implant
• Purpose of the "Study" (Non-Clinical Testing): To demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (Ascension® Modular Ulnar Head, K052137) in terms of intended use, technological characteristics, and performance (strength and function).
• Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is that the First Choice Partial Ulnar Head Implant's performance, as measured by the non-clinical tests, is comparable to, or as safe and effective as, the predicate device. This ensures the new device does not raise new questions of safety or effectiveness.
• Tests Performed:
  • Ulnar Head Biomechanics: Likely assessed mechanical properties related to joint articulation and stress distribution.
  • DRUJ Stem Bend Strength: Assessed the structural integrity and resistance to bending of the stem portion of the implant, which is fixed into the ulna.
• Outcome: The document states, "Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function." This statement is the conclusion that the device has met the implicit acceptance criterion for substantial equivalence based on the non-clinical testing.
• Why Clinical Data Wasn't Needed: For many 510(k) submissions, if the new device is sufficiently similar to a predicate, and non-clinical data can bridge any differences, clinical data is not required by the FDA. This was the case here, as noted: "Clinical performance data were not necessary to support substantial equivalence."

In summary, for medical devices cleared through the 510(k) pathway, the "acceptance criteria" are usually tied to demonstrating substantial equivalence to an already legally marketed device, often through non-clinical testing, rather than through a new clinical trial establishing standalone efficacy and safety metrics.

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The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications

• -Rheumatoid arthritis with or without tendon ruptures
• -Degenerative arthritis or post traumatic arthritis
  • 1. Arthrofibrosis of the DRUJ o
  • 2. Reconstruction of the distal ulna post tumor resection o
  • 3. Failed Ulnar Head Resection 0
  • 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
  • 5. Revision following failed ulnar head arthroplasty O
• Ulna stems are intended for uncemented use -

The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.

This document is a 510(k) summary for a medical device (IsoelasticU™ wrist joint ulnar prosthesis). It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SBI Uhead Implant). This is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device or AI/software.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Reported Device Performance Table: The document explicitly states that the device is "substantially equivalent" to the SBI Uhead Implant. The table provided compares features and indications for use between the IsoelasticU and the predicate device, not performance metrics against acceptance criteria.
2. No Study Described: There is no description of a clinical study, algorithm performance study, or any kind of test set evaluation to demonstrate the IsoelasticU™ meets specific performance metrics.
3. No AI Mentioned: The device is a physical prosthesis, not an AI or software device. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," or "standalone algorithm performance" are not applicable to this document.
4. Regulatory Approach: The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed predicate device, not on proving new performance against predefined quantitative criteria through a performance study.

In summary, the provided text does not contain the information required to answer your prompt because it is a 510(k) summary for a physical medical device (a prosthesis) that demonstrates substantial equivalence, not a performance study for an AI/software device or a novel device proving specific acceptance criteria.

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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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The SBI 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 disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.

This 510(k) summary for the SBI Ulnar Head Implant primarily focuses on establishing substantial equivalence to previously marketed devices. It does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on a specific study conducted for this 510(k) submission to demonstrate performance against acceptance criteria. Instead, it refers to documentation showing substantial equivalence.
• Details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The provided text is a regulatory submission for premarket notification (510(k)) for a medical device. A 510(k) typically demonstrates substantial equivalence to existing devices rather than requiring an extensive de novo clinical trial with defined acceptance criteria for performance in the same way a PMA submission might.

Therefore, many of your requested points cannot be answered from the provided text.

Here's what can be extracted from the document:

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

• Not Available. The document does not provide specific performance acceptance criteria or a "reported device performance" table as if from a study designed to meet specific metrics. It states, "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

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

• Not Available. There is no mention of a "test set" or a study in this context that would involve a sample size for performance evaluation. The substantial equivalence argument likely relies on design, material, and intended use comparison to predicate devices, rather than a new performance study.

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 / Not Available. This information is not relevant to a 510(k) substantial equivalence submission for this type of device. There is no mention of a "ground truth" establishment process within this document.

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

• Not Applicable / Not Available. No test set or adjudication method 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

• No. This is a physical implant device, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are not applicable.

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

• No. This is a physical implant device.

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

• Not Applicable / Not Available. The concept of "ground truth" as typically applied to diagnostic algorithms or imaging interpretation is not relevant for this device's 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Available. This is a physical implant device, not an AI algorithm. Therefore, there is no "training set."

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

• Not Applicable / Not Available. As above, no training set exists for this device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

This indicates that the "study" proving the device meets acceptance criteria (which, in a 510(k), are generally met by demonstrating equivalence to a predicate device) is a comparison against legally marketed predicate devices. The specific details of that "documentation" are not elaborated on in this summary but would typically include:

• Comparison of Intended Use: Showing the new device has the same intended use as predicate devices. (The document explicitly lists the intended use).
• Comparison of Technological Characteristics: Demonstrating that the new device has substantially similar technological characteristics (e.g., materials, design principles, operating principles) to predicate devices. (The document mentions material: "implantable grades of cobalt chrome (ASTM 1537-94), with CpTi coating.").
• Performance Data (if necessary): For an implant, this would primarily involve non-clinical testing (e.g., mechanical testing, biocompatibility testing) to ensure it performs safely and effectively in a similar manner to the predicate, or that any differences do not raise new questions of safety and effectiveness. This summary does not detail these non-clinical tests, but they would be part of the "documentation."

In summary, the provided text is a high-level summary for a 510(k) premarket notification. It asserts substantial equivalence to predicate devices as the basis for marketing clearance, rather than detailing a specific clinical performance study against pre-defined acceptance criteria.

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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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The Ascension® MUH is intended for replacement of the distal radioulnar joint:

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

• Pain and weakness of the wrist joint not improved by conservative treatment .
• Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
• Failed ulnar head resection .

The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.

The provided text is a 510(k) Summary for the Ascension® MUH ulnar head prosthesis, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria through clinical or analytical trials.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, as typically understood for a novel device. The "study" here is a comparison to a legally marketed predicate device.

Here's an analysis of why the requested information is absent based on the provided text:

• Acceptance Criteria and Reported Device Performance: These are not provided because the submission is for substantial equivalence to a predicate device, not for demonstrating performance against defined metrics for a novel technology. The "performance" being assessed is the equivalent design, materials, and intended use to the predicate.
• Sample size and data provenance: No test set or data provenance is mentioned because this is a medical device comparison submission, not a study involving patient data or a test set in the conventional sense of a clinical trial or algorithm validation.
• Number of experts and qualifications: Not applicable. Ground truth establishment is not relevant for this type of submission focused on device comparison rather than diagnostic accuracy or clinical outcomes.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers, not for a prosthetic device submission based on substantial equivalence.
• Standalone (algorithm-only) performance: Not applicable, as this is a physical prosthetic device, not an algorithm.
• Type of ground truth used: Not applicable, as there's no diagnostic or predictive component being evaluated.
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Comparison (used as the "study" for substantial equivalence):

The "study" presented is a comparison of features between the Ascension® MUH implant and the predicate device, Avanta Orthopaedics, Inc., Ulnar Head Implant (K010786).

Acceptance Criteria (Implicit for Substantial Equivalence):
The implicit acceptance criteria for substantial equivalence, as demonstrated by the comparison table, are that the subject device (Ascension® MUH) must have:

• Same Indications For Use: Confirmed, as stated in the text.
• Same/Similar Design: Confirmed (two-piece modular implant, taper connection, stem in medullary canal, hemi articulation).
• Same/Similar Materials: Confirmed (cobalt chromium for head, titanium for stem – a different grade of titanium for the stem, but considered acceptable for substantial equivalence to CpTi).
• Same/Similar Performance Characteristics: Implied by the above similarities and the lack of new questions of safety or effectiveness.
• No new questions of safety or effectiveness: Implied by the FDA's determination of substantial equivalence.

Reported Device "Performance" (Comparison to Predicate):

Below is a table summarizing the comparison, which serves as the "proof" for substantial equivalence.

Conclusion from the "Study":

The 510(k) summary explicitly states: "The Ascension® MUH is functionally identical, comparably sized, and has a similar design as compared to the Avanta Ulnar Head Implant. Individual components for the subject and predicate device are provided sterile in individual packages. The Ascension® MUH shares identical indications for use with the predicate device, and is fabricated from the same material as the predicate device. Therefore, the Ascension® MUH is substantially equivalent to the predicate device."

In summary, the provided document does not describe a performance study with acceptance criteria in the typical sense of evaluating a novel device's efficacy or safety against specific metrics. Instead, it presents a comparison to a predicate device to establish substantial equivalence based on design, materials, and intended use.

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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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The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.

The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.

The provided text describes a 510(k) premarket notification for the "Herbert Ulnar Head Prosthesis System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance in the context of AI/software device evaluation is not directly applicable to this document.

However, I can extract the relevant information from the document to address as many of your points as possible within the context of a 510(k) submission for a physical medical device.

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

For a 510(k) for a physical implant, "acceptance criteria" are typically related to meeting recognized standards and demonstrating equivalence to a predicate device in terms of design, materials, and intended use. Performance is demonstrated through comparison with the predicate and compliance with these standards.

• ISO 5832-2:1999 (Unalloyed Titanium)
• ISO 5832-3:1996 (Wrought titanium 6-aluminium 4-vanadium alloy)
• ISO 5832-12:1996 (Wrought cobalt-chromium-molybdenum alloy)
• ISO 7153-1:1991/Amd. 1:1999 (Surgical instruments Metallic materials - Stainless steel)
• ASTM F899 95 (Stainless Steel Billet, Bar and Wire for Surgical Instruments)
• ASTM F138 97 (Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants) |
  | Sterilization Process Compliance: Ensure the sterilization method meets recognized standards. | The device complies with:
• AAMI/ANSI/ ISO 11134:1993 (Sterilization of health care products - industrial moist heat sterilization)
• AAMI/ANSI ST46:2002 (Steam Sterilization and Sterility Assurance in Health Care Facilities) |
  | Technological Equivalence to Predicate Device: Demonstrate that the design and features are substantially equivalent to a legally marketed predicate device. | An "8-point comparison of technological characteristics" was performed between the Herbert Ulnar Head Prosthesis System and the predicate device (uHead Ulnar Implant System, K010786). The devices were found to be substantially equivalent based on this comparison. |
  | Intended Use Equivalence: Ensure the indications for use are the same or subset of the predicate device. | The indications for use match the predicate: for ulnar head and stem replacement necessitated by: 1) Failed operative procedures (Darrach, Bowers, Sauve-Kapandji), 2) Primary osteoarthritis, 3) Post-traumatic osteoarthritis, 4) Rheumatoid arthritis, and 5) Tumors. |
  | Manufacturing Standards: Adherence to good manufacturing practices. | The device "will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use." |

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 to this 510(k) submission. A test set in the context of device performance studies (like for AI/software) was not used. The clearance is based on comparison to a predicate device and adherence to recognized standards for materials and manufacturing.

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. There was no "test set" and thus no ground truth established by experts in the sense of a clinical performance study for this type of device submission.

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

Not applicable. No test set requiring adjudication was used.

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 for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. For this 510(k), the "ground truth" for clearance is the established performance and safety of the legally marketed predicate device and the recognized standards for materials and manufacturing, not a clinical ground truth established for a test set.

8. The sample size for the training set

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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