(146 days)
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
The provided text describes the Spectrum Spine Laminoplasty Plating System and its performance data for a 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance in those terms (apart from passing certain ASTM standards), or details about a study that would address most of the requested information.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing according to established ASTM standards. It does not describe a clinical study or a study comparing the device's performance against specific, quantifiable acceptance criteria in a clinical context.
Therefore, for many of your requested points, the information is not available in the provided text.
Here is the information that can be extracted or deduced from the provided text, and where the information is not available, it is stated as such:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Axial Pullout (screws per ASTM F543-07) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Static Four-Point Bend (system per ASTM F2193-02) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Dynamic Four-Point Bend (system per ASTM F2193-02) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Material Composition: | |
| Plates and screws manufactured from titanium alloy (ASTM F136) | Manufactured from titanium alloy (ASTM F136) |
| Indications for Use: | |
| Intended for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold allograft and prevent expulsion/impingement on spinal cord. | Indicated for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold or buttress allograft and prevent expulsion/impingement on spinal cord. |
| Technical Characteristics: | |
| No new technical characteristics compared to predicate devices. | No new technical characteristics introduced. |
Note on "Reported Device Performance": The document states that the device "was tested" according to specific ASTM standards and that the data "lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices." This implicitly means the device met the requirements of these tests, but the specific numerical results or thresholds (acceptance criteria) for those tests are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The testing described is mechanical (physical hardware testing), not clinical or involving human subjects/cases in the traditional sense of a "test set" for performance evaluation.
- Data Provenance: The "performance data" refers to mechanical testing.
- Country of origin: Not specified, but likely performed in a certified lab in the USA, given the FDA submission.
- Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical data collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The "ground truth" for this device's performance evaluation is based on established engineering standards (ASTM F543-07 and ASTM F2193-02) and material specifications (ASTM F136), not expert consensus from clinical cases. There's no mention of experts establishing a ground truth in the context of device performance as one would for an AI/diagnostic device.
4. Adjudication Method for the Test Set
- Not applicable. This concept typically applies to clinical studies where expert reviewers independently assess cases and then reconcile discrepancies. The reported testing is mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this type of mechanical implant device. This type of study is typically performed for diagnostic or AI-assisted interpretation devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Engineering Standards and Material Specifications: The ground truth for evaluating the device's safety and effectiveness for a 510(k) submission is based on adherence to established ASTM standards for mechanical properties (e.g., strength, durability) and material composition (titanium alloy as per ASTM F136), demonstrating substantial equivalence to previously marketed devices.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical surgical implant. There is no training set in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.