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The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.

The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points.

This document describes the Ceramic Tipped Skull Pin, a medical device intended for use in Halo Traction Systems. The primary study presented is a laboratory test comparing the Ceramic Tipped Skull Pin to a predicate Titanium Skull Pin based on mechanical integrity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices. The document mentions "Both the Ceramic Tipped Skull Pins and Generation 80 (Titanium) Skull Pins were tested." This implies at least one of each type, but the exact sample size for the mechanical tests is not detailed.
• Data Provenance: Laboratory tests. The country of origin is not specified, but the manufacturer, Jerome Medical, is based in Moorestown, New Jersey, USA. The data is prospective as it involves new laboratory testing of the devices.

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

• Not Applicable. This study is a laboratory performance test against a recognized standard (ASTM F 1831-97) for mechanical integrity. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense of clinical or image-based studies. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standard.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a laboratory test against a standard, there is no need for expert adjudication. The test results are objective measurements compared against the standard's requirements.

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 study is not an MRMC study. It does not involve human readers, AI, or clinical cases to assess diagnostic effectiveness or improvement with AI assistance. It focuses solely on the mechanical performance of a physical device.

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

• No. This is a hardware device. There is no algorithm or software involved to have a standalone performance.

7. The Type of Ground Truth Used

• Objective Standard Compliance: The "ground truth" is defined by the requirements of the ASTM F 1831-97 standard, section 11, for mechanical integrity of Halo Rings. The devices were tested to see if they met these predefined, objective criteria.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study was a laboratory comparison designed to demonstrate the mechanical integrity of the Ceramic Tipped Skull Pin against the predicate Titanium Skull Pin. Both devices were tested in accordance with ASTM F 1831-97, section 11. The key findings were that both the new Ceramic Tipped Skull Pin and the predicate Titanium Skull Pin met the requirements of this standard. The primary differences highlighted for the new device were the use of non-conductive materials for improved image quality and patient safety, and a thicker material for offset load strength, which were confirmed not to adversely affect product performance through these tests.

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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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