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The ExploR™ Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
   a) Joint destruction and/or subluxation visible on x-ray
   b) Resistance to conservative treatment
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
   The device is intended for single use with or without bone cement.

The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

This looks like a 510(k) premarket notification document for a medical device. Based on the provided text, the device is the ExploR™ Modular Radial Head Replacement Device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

1. Degenerative/post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction/subluxation on X-ray, resistance to conservative treatment)
2. Primary replacement after radial head fracture
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty |
   | Safety and Effectiveness | Demonstrated through substantial equivalence to predicate devices (K040611, K984290, K002644, K991915) based on technological characteristics (materials, design, sizing, indications) and non-clinical testing. |
   | Biocompatibility | Implied to be acceptable as it uses materials similar to legally marketed predicate devices. |
   | Mechanical Integrity | Engineering analysis and mechanical testing were provided. |

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "Clinical Testing: None provided as a basis of substantial equivalence."

This indicates that clinical studies were not performed to demonstrate the device meets acceptance criteria in the traditional sense of a clinical trial proving safety and efficacy. Instead, the basis for market clearance (substantial equivalence) relies on non-clinical data and comparison to predicate devices.

Given the lack of clinical testing, the following information points related to clinical studies (test sets, ground truth, expert involvement, MRMC, standalone performance, training sets) are not applicable in this case.

Therefore, for the specific questions you asked about a study proving the device meets acceptance criteria:

1. A table of acceptance criteria and the reported device performance: (Provided above) The acceptance criteria are largely implied by the description and intended use of the device, and its similarity to predicate devices. The reported performance refers to its physical characteristics and functionality as designed.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for substantial equivalence.

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 device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. No machine learning training set was used.

9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission successfully achieved market clearance based on non-clinical testing (engineering analysis and mechanical testing) and the demonstration of substantial equivalence to existing, legally marketed predicate devices. "Substantial equivalence" here means that the new device has the same intended use and technological characteristics as the predicate devices, or if there are differences, those differences do not raise new questions of safety or effectiveness. No clinical studies were required or provided.

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The Acumed Anatomic Radial Head System is indicated for use in:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection.
4. Revision following failed radial head arthroplasty

The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.

This document is a 510(k) summary for the Acumed Anatomic Radial Head System, a medical device for elbow replacement. It is important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through detailed studies in the way an AI/ML device submission would.

Therefore, many of the requested elements for an AI/ML device performance study are not applicable or not explicitly detailed in this type of submission.

Here's the breakdown based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. For a 510(k) submission like this, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing similar intended use, technological characteristics, and safety and effectiveness profiles.
• Reported Device Performance: No specific quantitative performance metrics are reported. The submission states, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that the substantial equivalence was primarily based on design and material similarities to the predicates, rather than new performance testing data detailed in this summary.

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

• Not Applicable. This submission does not describe a "test set" for performance evaluation in the context of an AI/ML device. It focuses on the substantial equivalence of the physical implant itself to existing devices.

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 is no "test set" or ground truth establishment in this context.

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

• Not Applicable. No test set for performance evaluation 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

• Not Applicable. This is a physical prosthetic device, not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This is a physical prosthetic device.

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

• Not Applicable. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, supported by its design, materials, and intended use aligning with those already found safe and effective.

8. The sample size for the training set

• Not Applicable. There is no training set for an AI/ML model in this submission.

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

• Not Applicable. There is no training set for an AI/ML model in this submission.

Summary of the document's approach to demonstrating safety and effectiveness:

The submission for the Acumed Anatomic Radial Head System demonstrates substantial equivalence to predicate devices (Avanta Radial Head Implant K002644 and Wright Medical Inc. Modular Radial Head K991915). The key arguments for substantial equivalence are:

• Intended Use: The indications for use are similar to the predicate devices.
• Technological Characteristics: The device uses similar materials (cobalt alloy head, titanium alloy stem) that have been successfully used in numerous implant prostheses, and its elliptical shape is aligned with anatomical replacement principles. The submission explicitly states, "There are no technological characteristics that raise new issues of safety or effectiveness."
• Performance Data/Testing: The submitter explicitly states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This is typical for a 510(k) where substantial equivalence is established through design, materials, and intended use comparison, implying that the safety and effectiveness are established by the long-standing use and prior approval of the predicate devices with similar characteristics.

In essence, for this type of medical device (a mechanical implant), the "acceptance criteria" and "proof" primarily revolve around demonstrating that it is fundamentally the same as or very similar to devices already on the market and has no new safety or effectiveness concerns.

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