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The Align Radial Head System and accessories are designed specifically for:

• 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:
  • o Joint destruction and/or subluxation.
  • o Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.

The system is intended for press fit use.

The subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.

The provided text is a 510(k) summary for the ALIGN Radial Head System, which is a medical device for radial head replacement. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested sections related to AI/ML study components (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not applicable to this type of regulatory submission and are not present in the provided text.

The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.

Here’s the information based on the provided text, with "N/A" for sections not covered by this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

N/A. This document describes mechanical testing of a physical medical device, not a study involving a "test set" of data or patient provenance in the context of an AI/ML device. The testing would involve physical samples of the device components. The document does not specify the number of samples used for static and fatigue compression testing.

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)

N/A. Not applicable to mechanical testing of a physical implant.

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

N/A. Not applicable to mechanical testing of a physical implant.

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

N/A. Not applicable as this is not an AI/ML device.

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

N/A. Not applicable as this is not an AI/ML device.

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

For the mechanical testing, the "ground truth" would be established engineering standards and specifications for material strength, fatigue life, and structural integrity under simulated physiological loads, which are used to determine if the device performs equivalently to the predicate. This document does not elaborate on specific standards or the methodology of establishing "ground truth" beyond stating "mechanical testing" was performed.

8. The sample size for the training set

N/A. Not applicable as this is not an AI/ML device.

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

N/A. Not applicable as this is not an AI/ML device.

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The Align Radial Head System and accessories are designed specifically for
· 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:

• o Joint destruction and/or subluxation,
• o Resistance to conservative treatment.
• · Primary replacement after fracture of the radial head.
• · Symptomatic sequelae after radial head resection.
• · Revision following failed radial head arthroplasty.

The system is intended for press fit use.

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.

The Align Radial Head System is comprised of:

• · Multiple sized CoCr Radial Heads with Locking Screw
• Multiple sized titanium alloy Stems, titanium plasma spray coated
• · System specific instrumentation.

This document is a 510(k) premarket notification for the "Align Radial Head System," a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria with quantifiable metrics. Therefore, many of the requested categories for device performance studies cannot be directly extracted or are not applicable.

Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not directly relevant to the request as phrased for AI/software-centric device studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing." However, specific quantitative acceptance criteria (e.g., "shear strength must be > X MPa") and the exact numerical results are not provided.

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

This information is not provided in the document. The testing mentioned (mechanical and characterization) would involve physical samples of the device, not a "test set" of data in the context of an AI/software study. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of device testing described.

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

This information is not applicable/provided. The ground truth for this device (an implantable prosthesis) would be established through engineering specifications, material science, and pre-clinical mechanical testing, not by expert consensus on a test set in the way AI/software studies use "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for human review of data or images to establish ground truth, which is not the type of testing described for this physical medical 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

This information is not applicable. This document describes an orthopedic implant, not an AI or software device that assists human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through engineering specifications, material properties, and physical mechanical testing results (static, shear, and abrasion tests) designed to confirm the device's functional integrity and safety. It's not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable/provided. As above, this device does not use a "training set" in the computational sense.

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The Align Radial Head System and accessories are designed specifically for:

• 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.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.

The system is intended for press-fit use.

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit into the medullary canal of the radius. Combined with its unique instrumentation, the ALIGN Radial Head offers the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.

The Align Radial Head System is comprised of:

• Multiple sized CoCr Radial Heads with Locking Screw .
• Multiple sized titanium allov Stems, titanium plasma spray coated .
• Stainless Steel K-Wires for optimal prosthesis alignment (not to be implanted)
• System specific instrumentation

The provided document is a 510(k) summary for the Align Radial Head Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a comprehensive study to prove device performance against such criteria as one might see for a diagnostic AI device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable for this type of medical device submission (an orthopedic implant). The submission relies on non-clinical testing (mechanical fatigue and static tests, and cadaver studies) and material biocompatibility.

Here's an analysis based on the available information:

Device: Align Radial Head Arthroplasty System

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present specific quantitative acceptance criteria in the format typically seen for AI/diagnostic devices (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implied by the demonstration of:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of clinical trials or AI/diagnostic performance. The "tests" here refer to non-clinical mechanical and cadaveric studies.
• Data Provenance: Not applicable. The studies are laboratory-based (mechanical tests) and cadaveric. No patient data (retrospective or prospective) from specific countries is mentioned or required for this type of submission.

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

• Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by engineering specifications and material standards. For cadaver studies, the assessment of surgical repeatability would be performed by experienced surgeons, but specific numbers and their qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies primarily to image-based diagnostic studies involving multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers. The Align Radial Head Arthroplasty System is an implantable device, not a diagnostic tool.

6. Standalone Performance Study

• Standalone Performance Study: No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This concept is for AI algorithms. The "standalone performance" for this device would be its mechanical integrity and biocompatibility, as evaluated by the non-clinical tests described.

7. Type of Ground Truth Used

The "ground truth" for this device is established through:

• Engineering specifications and validated testing methods for mechanical properties (fatigue, static loads).
• Biocompatibility standards and historical safe use data for materials.
• Surgical expertise for assessing the repeatability of the implantation procedure in cadaveric models.
• Comparison to legally marketed predicate devices for substantial equivalence (e.g., indications for use, materials, basic shape).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

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