(168 days)
The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
The provided text is for a 510(k) summary for the SP-Fix™ Spinous Process Fixation Plate, a medical device. It does not describe or include an AI device or a study involving AI. Therefore, I cannot provide information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria.
The information provided pertains to the mechanical testing of a physical medical device to demonstrate its substantial equivalence to predicate devices, which is a standard regulatory pathway for non-AI medical devices.
Here's what I can extract from the provided text about the device and its testing:
| Acceptance Criteria Category | Description from Document | Reported Device Performance |
|---|---|---|
| Device Substantial Equivalence | The purpose of the submission is to add the SP-Fix™ Spinous Process Fixation Plate to the REVERE® Stabilization System. The device must demonstrate substantial equivalence to predicate devices (Medtronic Spire™, LANX Aspen™, NuVasive AFFIX™) in terms of technical characteristics, performance, and intended use to be cleared by the FDA for marketing. | "The SP-Fix™ has been demonstrated to be substantially equivalent to predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s)." This statement implies that the device met the necessary criteria to be considered substantially equivalent to the predicates. |
| Mechanical Performance | Mechanical testing must be conducted to prove the device's functional integrity and safety under various loading conditions, comparable to predicate devices. This includes static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension. The implied acceptance criterion is that the SP-Fix™ performs similarly or better than the predicate devices under these tests. | "Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s)." The successful clearance by the FDA (K102195) confirms that these tests were sufficient to establish acceptable performance relative to the predicates. |
Regarding the specific questions about AI device studies:
Since this document describes a physical medical device and its mechanical testing for regulatory clearance, the following points are not applicable and cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for mechanical testing.
- Adjudication method for the test set: Not relevant for mechanical testing.
- 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: Not relevant for a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for mechanical testing. The "ground truth" for mechanical testing is typically engineering specifications and performance benchmarks derived from predicate devices or industry standards.
- The sample size for the training set: Not relevant as there is no AI model being trained.
- How the ground truth for the training set was established: Not relevant as there is no AI model being trained.
The document states that mechanical testing was performed to demonstrate substantial equivalence. This type of testing involves subjecting the device to various physical forces and measuring its response, not analyzing data with an AI 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.