(81 days)
The ALPHA™ Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. The system is intended only patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
NOTA BENE: The ALPHA" Posterior Spinal System is limited to non-cervical use. All implant components of the ALPHA" Posterior Spinal System are intended for posterior spinal fixation. The ALPHA" Posterior Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The ALPHA" screws are indicated only for insertion no higher than L3 and not lower than the sacrum. CD HORIZON" Low Profile MULTI-SPAN" CROSSLINK® plates, ALPHA" Low Profile MULTI-SPAN" CROSSLINK® plates, TSRH® Low Profile CROSSLINK® plates, and TSRH® Low Profile CROSSLINK® Offset plates are intended for posterior thoracic, lumbar, and/or sacral use only.
The ALPHA" Posterior Spinal System is a spinal rod based system. The ALPHA" implant components, as well as implant components from the other systems, can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the ALPHA system and those components from other Sofamor Danek spinal systems which can be used with the ALPHA~ Posterior Spinal System are listed in the following table. Please note that while the set screws can be used on both size rods, all of the other components are rod-size specific.
The provided text describes a medical device, the ALPHA™ Posterior Spinal System, which is a spinal rod-based system for posterior spinal fixation. It details the components of the system, its intended use (for severe spondylolisthesis at L5-S1), and the patients for whom it is indicated.
However, the text does not contain any information regarding acceptance criteria, device performance metrics, or any studies (clinical or otherwise) that would typically involve sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness with human readers.
The document states: "Mechanical test data were supplied in support of the ALPHA™ Posterior Spinal System 510(k) V. notification. The ALPHA" Posterior Spinal System was declared to be substantially equivalent to several commercially available devices." This indicates that mechanical testing was likely performed to demonstrate substantial equivalence, but the specific acceptance criteria, test results (performance), and details of that mechanical testing are not provided in the excerpt.
Therefore, I cannot fulfill the request to complete the table or answer the specific questions related to acceptance criteria, device performance, study details, sample sizes, experts, or ground truth, as none of this information is present in the input.
A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Information not provided in the text. | Information not provided in the text. |
Detailed Answers to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- As noted above, this information is not provided in the text. The document refers to "Mechanical test data" but does not detail the criteria or the results.
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Sample sized 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 text. The mention of "Mechanical test data" suggests laboratory testing, not clinical data with human subjects.
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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 text. This type of information would be relevant for clinical studies, which are not described here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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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 information is not provided in the text. Given that this is a physical spinal implant system from 1997, it's highly unlikely that an AI-assisted MRMC study would have been conducted or would even be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not provided in the text. This concept is not applicable to a physical spinal implant device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not provided in the text. For mechanical testing, the "ground truth" would likely be engineering specifications and measurements.
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The sample size for the training set:
- This information is not provided in the text. The concept of a "training set" is generally associated with machine learning or AI algorithm development, which is not applicable here.
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How the ground truth for the training set was established:
- This information is not provided in the text.
§ 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.