(27 days)
The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications:
- degenerative disc disease (DDD) (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);
- spinal stenosis;
- curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
- pseudoarthrosis;
- and failed previous fusion.
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The USA Locking Plate System consists of a multiple sized plates and screws. All components are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the thoraco-lumbar and lumbar spine. The bone plates offer slotted and round holes that allow the bone screws to be located and securely seated in various positions. There are two plate configurations available: the straight locking plate and the narrow locking plate. The screws include the universal locking screw, the self locking screw and the cancellous locking screw.
The provided text describes a medical device, the "Universal Spinal Anterior Locking Plate System," and its 510(k) submission. However, the document does not contain information related to acceptance criteria, specific device performance numerical values, or details of a study that would prove the device meets such criteria.
The submission focuses on establishing substantial equivalence to a predicate device (Amset Locking Plate K905023) primarily based on design and indications, with the main difference being a change in material. It mentions "Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate," but no specific loads, acceptance criteria, or a study report are provided.
Therefore, I cannot populate the table or answer most of the questions as the necessary information is not present in the provided text.
Here is what I can state based on the text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate." (Specific values and criteria not given) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "Engineering analyses," which typically refers to mechanical testing or simulations, but no details on sample size or data provenance are provided.
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)
- Not applicable/Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., imaging studies or diagnostic devices). This document describes a surgical implant, and the assessment is based on engineering analyses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. 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
- No. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in terms of "ground truth" for a clinical study. For mechanical performance, the "ground truth" would be established physical material properties and mechanical testing standards. The document only mentions "Engineering analyses."
8. The sample size for the training set
- Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable/Not specified. This device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.
§ 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.