(175 days)
The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.
The Osteonics" Halifax " Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and 13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.
This document is a 510(k) summary for a medical device called the "Osteonics Halifax Plus Interlaminar Clamp System." It is a submission to the FDA to demonstrate substantial equivalence to a previously approved device. As such, it does not contain the information you requested regarding acceptance criteria and a study proving device performance as would be found in a clinical trial report or a performance validation study for an AI/CADe device.
Here's why the requested information cannot be extracted from this document:
- Type of Device: The Osteonics Halifax Plus Interlaminar Clamp System is a physical medical device (spinal fixation components), not a diagnostic algorithm or AI software.
- Regulatory Pathway: The 510(k) pathway for physical devices primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical performance studies against specific acceptance criteria for a novel algorithm.
- "Performance Data" Section: The document explicitly states: "As the components of the Osteonics Halifax Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME Halifax Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary." This means no new performance studies were conducted for this particular submission.
Therefore, I cannot provide a table of acceptance criteria, details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission does not contain that kind of data or evaluation.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "DEC" followed by the number 9 and the number 100. The text is in black and appears to be handwritten. The image is cropped closely around the text.
510(k) Notification Summary of Safety and Effectiveness for the Osteonics Halifax Plus Interlaminar Clamp System
Submission Information
| Name and Address of the Sponsorof the 510(k) Submission: | Osteonics Corporation59 Route 17Allendale, NJ 07401-1677 |
|---|---|
| Contact Person: | Chuck RyanRegulatory Affairs Team Leader |
Date of Summary Preparation:
June 10, 1996
Device Identification
| Proprietary Name: | Osteonics Halifax Plus Interlaminar ClampSystem |
|---|---|
| Common Name: | Spinal Fixation Components |
| Classification Name/Reference: | Spinal Interlaminal Fixation Orthosis21 CFR §888.3050 |
Predicate Device Identification:
The components of the Osteonics Halifax Plus Interlaminar Clamp System are identical and thus substantially equivalent to those of the AME* Halifax* Plus Interlaminar Clamp System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K850039. (Note: In K850039, the AME" Halifax " Plus Interlaminar Clamp System was identified as the Halifax Spinal Clamp System, manufactured by AME's predecessor, Levtech, Inc.)
Description of Devices:
The Osteonics" Halifax " Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and
{1}------------------------------------------------
13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.
Intended Use:
The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.
Statement of Technological Comparison:
The designs, materials, intended use, and general manufacturing processes characterizing the components of the Osteonics Halifax® Plus Interlaminar Clamp System are identical to those of the predicate AME Halifax Plus Interlaminar Clamp System.
Performance Data:
As the components of the Osteonics" Halifax Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME Halifax " Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.