(131 days)
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:
| Characteristic | PMT Halo System Performance |
|---|---|
| Imaging Capability | Compatible with C-ray, CT and 3-Tesla MR Conditional |
| Performance | Halo ring and skull pins meet ASTM F1559:1994 |
| MR Conditional 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). |
| 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.
§ 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).