(84 days)
The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.
The SpineFrontier® LESPlasty™ System consists of various sized plates and screws designed for a systematic posterior approach to cervical laminoplasty procedures. The plates have screw holes which allow for attachment to the lamina and the lateral mass. The system is provided with primary and recovery bone screws for fixation. Plates and screws are fabricated from medical grade titanium alloy (ASTM F136).
The provided text describes the SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System, a medical device. The information details the device's technical characteristics, indications for use, and performance data from non-clinical testing. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.
The document discusses the substantial equivalence of the LESPlasty™ System to predicate devices based on mechanical performance tests, which are standard for implantable devices, not AI/ML systems. Therefore, I cannot fulfill all parts of your request as it pertains to AI/ML specific criteria.
Here's a breakdown of the available information, noting the absence of AI/ML specific details:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical mechanical testing, but does not explicitly state numerical acceptance criteria in the format of a table with pass/fail thresholds. Instead, it concludes the device's strength is sufficient and substantially equivalent to predicate devices.
| Test Mode | Reported Device Performance | Acceptance Criteria (Not explicitly stated as numerical thresholds) |
|---|---|---|
| Static Axial Pullout | Sufficient for intended use; Substantially equivalent to predicate devices. | Strength comparable to legally marketed predicate devices. |
| Static Four-Point Bending | Sufficient for intended use; Substantially equivalent to predicate devices. | Strength comparable to legally marketed predicate devices. |
| Dynamic Four-Point Bending | Sufficient for intended use; Substantially equivalent to predicate devices. | Strength comparable to legally marketed predicate devices. |
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 testing described is mechanical (material and device component testing), not related to clinical data or patient samples. The document focuses on the device itself rather than data used to train or evaluate an AI/ML model for diagnostic or predictive purposes.
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 applicable and not provided in the document. The "ground truth" for the mechanical tests would be the physical properties and performance metrics measured according to specified ASTM standards. There is no mention of human experts establishing ground truth in the context of diagnostic interpretations or classifications for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are relevant for human interpretation tasks, especially in clinical studies or expert review of AI outputs. This document describes mechanical engineering tests.
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 information is not applicable and not provided. An MRMC study involves human readers evaluating cases, often to assess the impact of an AI tool. This submission is for an implantable medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. This document pertains to the physical performance of a medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical tests, the "ground truth" would be the direct measurements of material strength, fatigue resistance, and other physical properties as defined by the ASTM standards (ASTM F-543 for static axial pullout and ASTM F-2193 for static and dynamic four-point bending). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this context.
8. The sample size for the training set:
This information is not applicable and not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. There is no training set for this type of device.
In summary, the provided document is a 510(k) summary for a spinal implant system, focusing on its mechanical equivalency to predicate devices. It does not contain any information related to AI/ML performance, clinical evaluation with human readers, or ground truth establishment in the context of an algorithm.
§ 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.