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The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull immobilized following surgery or injury.

This document describes a 510(k) premarket notification for the "ReSOLVE Open Back Halo Ring." The submission aims to demonstrate substantial equivalence to a predicate device, the "ReSOLVE Closed Back Halo Ring (K023959)," and also references the "V1 Halo Ring (K930153)".

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the 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)

The document mentions "Non-clinical Tests" and "Laboratory tests confirm," but does not explicitly state the sample size used for the testing of the ReSOLVE Open Back Halo Ring or the ReSOLVE Closed Back Halo Ring. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 information is not provided. The study is a non-clinical, mechanical integrity test, so expert ground truth establishment in a medical diagnostic context is not applicable.

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

This is not applicable as the study involves non-clinical mechanical testing, not a human reader assessment.

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, an MRMC comparative effectiveness study was not done. This device is a medical hardware device (Halo Ring for cervical immobilization), not an AI-assisted diagnostic tool.

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

Yes, a standalone performance test was done, but it's a mechanical performance test, not an algorithm's performance. The "laboratory tests" confirmed that the "new open back design meets the standard for mechanical integrity as the previously approved ReSOLVE Closed Back Ring." This refers to the device's physical properties.

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

The "ground truth" for this non-clinical test is the standard of ASTM F 1831-97, Section 11. This is a recognized industry standard for the mechanical integrity of Halo Rings. The testing determines if the device meets or exceeds the specified requirements of this standard.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.

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

This information is not applicable, as there is no "training set" for this type of device and study. The "ground truth" for the performance evaluation is the ASTM standard.

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The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury.

The provided document describes a 510(k) premarket notification for the Jerome Glass Ring, demonstrating its substantial equivalence to a predicate device. This type of submission does not typically include clinical efficacy studies as would be seen for novel or high-risk devices. Instead, it relies on comparative technical performance to established standards.

Here's an analysis of the acceptance criteria and the "study" 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

• Test Set Sample Size: Not explicitly stated. The document refers to meeting a standard (ASTM F 1831 - 97), which would dictate the number of test samples required. However, the specific number of Jerome Glass Rings tested to demonstrate conformance is not provided.
• Data Provenance: The device performance is based on mechanical testing conducted to meet an ASTM standard. This implies a laboratory or engineering testing environment. The document does not provide information on the country of origin of this testing data or whether it was retrospective or prospective in a clinical sense. It's a materials and mechanical performance test, not a clinical trial.

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

• This type of information is not applicable to this submission. The "ground truth" for mechanical integrity is established by the ASTM F 1831 - 97 standard itself, which defines the test methods and acceptance limits. It would be an engineering determination based on empirical data from the tests, not an expert panel reviewing clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" refers to mechanical performance testing, there is no adjudication process in the sense of clinical review or consensus between experts. The results are compared directly to the specifications of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This is a medical device for mechanical support and immobilization, not a diagnostic imaging device utilizing AI. Therefore, the concept of human reader improvement with AI assistance is not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This device does not incorporate an algorithm or AI component.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance is adherence to the mechanical specifications and testing methodology outlined in the ASTM F 1831 - 97 standard. This standard serves as the benchmark for demonstrating that the device is fit for its intended mechanical purpose.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a mechanical medical device, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth to establish in this context.

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