(71 days)
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.
The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.
The provided text describes the Katia System, a medical device for anterior interbody screw fixation of the cervical spine, and its 510(k) summary. However, the document does not contain the specific information required to complete the table and answer all the questions regarding "acceptance criteria" and "device performance" in terms of clinical or algorithmic efficacy. The provided text focuses on regulatory approval, device description, indications for use, and mechanical performance testing against ASTM standards.
Therefore, for aspects related to clinical or algorithmic performance, acceptance criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment, the information is not available in the given document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The text states "Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004." While these documents define acceptance criteria for mechanical performance, the specific criteria (e.g., specific load limits, displacement thresholds) and the device's reported performance against these criteria are not detailed in the provided text. The 510(k) summary typically includes a statement that the device met these standards, but not the raw data or specific values. Without access to the full test report, this information cannot be provided.
- Reported Device Performance: As above, specific quantitative performance data for mechanical tests (e.g., cyclic loading, static compression, screw pull-out strength) against the ASTM standard are not included in this summary.
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 available in the provided text. The document refers to mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI/diagnostic device evaluation.
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 available in the provided text. This device is a surgical implant, and the approval detailed here is based on substantial equivalence to predicate devices and mechanical performance testing, not on a diagnostic or AI-driven evaluation that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided text. (See point 3).
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 available in the provided text. This type of study is relevant for diagnostic imaging AI, not for a spinal implant like the Katia System.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not available in the provided text. (See point 5).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not available in the provided text. The "ground truth" for a spinal implant's approval typically revolves around manufacturing quality, biocompatibility, and mechanical strength/durability demonstrated through laboratory testing, not medical image interpretation or clinical outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
- This information is not available in the provided text. (See point 5).
9. How the ground truth for the training set was established
- This information is not available in the provided text. (See point 5).
Summary of available information related to performance testing:
- Performance Testing Method: Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.
- Device Type: Spinal intervertebral body fixation orthosis (implant).
- Approval Basis: Substantial equivalence to predicate devices (K081038, K111132, K031276, K971883) and adherence to mechanical testing standards.
Conclusion:
The provided document details regulatory information and mentions mechanical performance testing standards but does not provide the specific acceptance criteria or reported device performance data for these tests, nor does it contain any information relevant to the evaluation of an AI-driven or diagnostic device (e.g., clinical test/training sets, ground truth establishment, expert adjudication, MRMC studies).
§ 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.