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The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

• Static magnetic field of 1.5T and 3T only .
• Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
• Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities.

To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.

The provided text describes the PMT Halo System, a device for cervical immobilization. It details the device's components, materials, and its MRI compatibility. However, the document does not contain information about acceptance criteria, specifics of a study proving device performance against such criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use, particularly its MR Conditional designation.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted or inferred:

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

The document does not explicitly state "acceptance criteria" or a study proving performance against them. It states:

• Maximum spatial gradient magnetic field of 720 Gauss/cm or less
• Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence). |
  | Sterility | Skull pins, rings, and positioning pins ETO Sterilized to ANSIAAMI/ISO 11135:2007 and EN556:2001 |

Comment: The "acceptance criteria" appear to be compliance with specific ASTM and ISO standards, and safe operation under defined MRI conditions. The "reported device performance" is that the device meets these standards and conditions.

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 provided in the document. The document refers to meeting standards (ASTM F1559:1994, ANSIAAMI/ISO 11135:2007, EN556:2001) for performance and sterility, which implies testing was performed, but details of the test sets (sample size, provenance) are absent.

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 in the document.

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

This information is not provided in the document.

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 as the device described (PMT Halo System) is a physical medical device (halo system for cervical immobilization), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers with/without AI assistance would be relevant or performed.

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

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

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

The "ground truth" for this type of device would likely be adherence to engineering specifications, material properties, and functionality under test conditions. The document states that the "Halo ring and skull pins meet ASTM F1559:1994" and sterility meets specific ISO standards. These standards themselves define the "ground truth" for performance.

8. The sample size for the training set

This is not applicable for a physical medical device. There is no "training set" in the context of machine learning.

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

This is not applicable for a physical medical device.

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The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

1. Acceptance Criteria and Device Performance:

2. Sample size and data provenance:

No human or patient data was used in this evaluation. The "sample size" refers to the tested tongs. The description indicates "Laboratory tests" without specifying the number of tongs tested. The provenance is likely from the manufacturer's internal testing facilities.

3. Number of experts and their qualifications:

Not applicable. This device is a mechanical tool, and its performance was evaluated through a non-clinical, objective standard (ASTM F 1831-97), not by expert interpretation.

4. Adjudication method:

Not applicable. The evaluation was based on meeting a pre-defined objective standard (ASTM F 1831-97), not on subjective assessment requiring adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

Not applicable. This is a mechanical device, not an AI or imaging diagnostic tool that would involve human readers.

6. Standalone (algorithm only without human-in-the-loop) performance:

The device's performance was evaluated in a standalone manner against the ASTM F 1831-97 standard. This is akin to a "standalone" evaluation for a mechanical device.

7. Type of ground truth used:

The ground truth was established by the ASTM F 1831-97 standard for Mechanical Integrity of Cranial Traction Tongs. This is an objective, standardized test method defining acceptable mechanical performance.

8. Sample size for the training set:

Not applicable. This is a mechanical device, not an AI model that requires a training set.

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

Not applicable. There was no training set for this mechanical device.

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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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This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.

The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.

The provided text is a 510(k) summary for the Friddle Halo System™, a medical device for cervical spine immobilization and traction. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than providing a study proving its performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth for a performance study is not available in the provided document.

Here's why and what the document does provide:

• Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or that any differences do not raise new questions of safety and effectiveness. It does not typically require a full clinical performance study with acceptance criteria in the same way a Premarket Approval (PMA) would.
• Performance Standards: The document explicitly states "Performance standards: None." This further indicates that there wasn't a formal set of acceptance criteria that the device's performance was measured against in a clinical study for this submission. The titanium alloy meeting ASTM specifications is a material characteristic, not a performance metric of the device in use.

Information that can be extracted from the document related to the request:

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

   • Not applicable (N/A). The document does not define specific performance acceptance criteria for a study demonstrating efficacy or safety of the device itself beyond material specifications.
   • Reported Device Performance: The primary claim is "substantial equivalence" to other halo systems.

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. No formal test set or clinical study to assess performance beyond comparison to predicate devices is described.

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. As no formal test set or clinical study is described, there's no mention of experts establishing ground truth for such a study.

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

   • N/A. No adjudication method is mentioned as there is no described test set or performance study.

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. This device is a mechanical medical device (halo system), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.

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

   • N/A. This device is a mechanical device, not an algorithm.

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

   • N/A. For this 510(k) submission, the "ground truth" for demonstrating equivalence largely relies on comparing the design, materials, and intended use of the Friddle Halo System to predicate devices that have already been cleared by the FDA.

8. The sample size for the training set:

   • N/A. There is no mention of a training set as this is not an AI/algorithm device.

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

   • N/A. There is no mention of a training set or its ground truth.

In summary, the provided document is a 510(k) premarket notification, which establishes substantial equivalence rather than presenting data from a clinical performance study against pre-defined acceptance criteria.

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