(59 days)
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
| Acceptance Criteria | Ceramic Tipped Skull Pin Performance | Titanium Skull Pin Performance (Predicate) |
|---|---|---|
| Mechanical Integrity (ASTM F 1831-97) | Meets requirements of ASTM F 1831-97, section 11 | Meets requirements of ASTM F 1831-97, section 11 |
| Electrical Safety | Non-conductive | Conductive |
| Imaging Compatibility | Compatible with X-ray, CT, MR | Compatible with X-ray, CT, MR |
| Sterility | EtO Sterilized | EtO Sterilized |
| Materials | Ti6AI4V Titanium, ZrO-ATP BIO-HIP Ceramic, Epoxy | Ti6A14V Titanium |
| Design | Threaded Skull Pin | Threaded Skull Pin |
| Size(s) | 1 size | 2 sizes |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.