(360 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 882.5960 Skull tongs for traction.
(a)
Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.(b)
Classification. Class II (performance standards).