(20 days)
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal system is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 - S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.
5.0mm Diameter Polyaxial Screws for the Moss Miami 6.35mm System. Manufactured from ASTM F-136 implant grade titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel.
This 510(k) summary provides minimal information regarding the performance data, primarily stating that "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm System.)." It does not detail specific acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document is primarily a regulatory filing for substantial equivalence based on predicate devices, rather than a detailed scientific study report with performance metrics.
Here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified (The document only states "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws") |
2. Sample size used for the test set and data provenance:
- Not specified. The document mentions "Data were submitted to characterize the 5.0mm diameter Polyaxial Screws," but gives no details about the nature of this data, its sample size, or its provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable / Not specified. This document is for a spinal fixation system, not an AI/diagnostic device that typically involves human expert ground truth for interpretation. The "performance data" would likely refer to mechanical testing, biocompatibility, and sterilization, rather than diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable / Not specified. Similar to point 3, this is irrelevant for a mechanical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is for diagnostic or AI-assisted interpretation devices. The document concerns a physical spinal implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI algorithms, not a physical implant.
7. The type of ground truth used:
- N/A (likely mechanical testing standards). For a spinal fixation system, "ground truth" would typically refer to established engineering standards for mechanical strength, fatigue, corrosion resistance, and biocompatibility. The document notes the materials are "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel," implying adherence to these material standards. However, specific performance metrics are not provided.
8. The sample size for the training set:
- Not applicable. This question pertains to machine learning models, not a physical medical device like a spinal screw system.
9. How the ground truth for the training set was established:
- Not applicable. Same as 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.