(85 days)
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF ™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. Material: PEEK-OPTIMA LT1
This is actually an FDA 510(k) summary for a medical device (STALIF TT™ SYSTEM), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria and study design for AI models does not apply.
However, I can extract the relevant information from the provided document regarding device performance and its regulatory approval process, which serves as a form of "acceptance criteria" for medical devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For a medical device like the STALIF TT, "acceptance criteria" are typically based on demonstrating substantial equivalence to a legally marketed predicate device, as well as meeting established performance standards through various testing. The document states "Performance data were submitted." This implies that the device underwent various tests to prove its safety and effectiveness, likely against a set of predetermined criteria based on engineering standards and expected biological response.
However, the specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life cycles) and the detailed results are not disclosed in this summary. The summary only confirms that performance data was submitted and found acceptable by the FDA for its 510(k) clearance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (DePuy AcroMed Stackable Cage™ System) | Found to be substantially equivalent by FDA (K041617) |
| Biomechanical integrity (anterior column support) | Designed to restore biomechanical integrity and provide anterior column support immediately and for prolonged periods. Performance data submitted to FDA and found acceptable for clearance. |
| Material compatibility (PEEK-OPTIMA LT1) | PEEK-OPTIMA LT1 is a known biocompatible material, implicitly meeting acceptance criteria. Performance data submitted to FDA and found acceptable for clearance. |
| Use with supplemental internal fixation | Indicated for use with supplemental internal fixation systems (list provided), implying compatibility testing was conducted. Performance data submitted to FDA and found acceptable for clearance. |
| Restoration of planar alignment and height | Designed to restore planar alignment and height of collapsed vertebral body. Performance data submitted to FDA and found acceptable for clearance. |
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 510(k) summary. For medical devices, "test sets" typically refer to mechanical, biocompatibility, and potentially animal studies, not human clinical data in the same way an AI study would. The data provenance would refer to the testing lab and the standard(s) adhered to.
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 is not applicable to a medical device 510(k) submission in the context of expert consensus for ground truth. Ground truth for a device like this would be established through engineering specifications, material properties, and pre-clinical testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to a medical device 510(k) submission. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or AI validation.
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 is not applicable. The STALIF TT is a physical medical implant, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The STALIF TT is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance would be established through a combination of:
- Engineering specifications and standards: Confirming material properties, mechanical strength (e.g., compression, fatigue, subsidence), and dimensional accuracy.
- Biocompatibility testing: In vitro and potentially in vivo (animal study) testing to ensure the material is safe for implantation.
- Pre-clinical (benchtop) testing: Simulated use conditions to verify the device's mechanical performance under expected physiological loads.
8. The sample size for the training set
This is not applicable. The STALIF TT is a physical medical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The STALIF TT is a physical medical implant, not an AI model.
In summary: The provided document is a regulatory notice for a medical device, not a study evaluating an AI system. The "acceptance criteria" here refer to meeting FDA requirements for market clearance through demonstrating substantial equivalence and submitting adequate performance data, rather than specific performance metrics for an AI algorithm.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.