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The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws, washers and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided document is a 510(k) summary for the ZPLATE-ATL™ Anterior Spinal Fixation System. It describes the device, its indications for use, and a statement of substantial equivalence. However, it does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states that "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself," which implies a predicate device was not explicitly named or it was a new iteration of their own previously cleared device, but it doesn't describe how that substantial equivalence was demonstrated in terms of performance metrics or clinical study results.

Therefore, much of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify any performance acceptance criteria or report specific performance metrics from a study related to these criteria. The approval is based on "substantial equivalence" as opposed to meeting defined performance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe any specific study, test set, sample sizes, or data provenance.

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)

• Cannot be provided. No information on ground truth establishment or expert involvement for a test set is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No adjudication method is mentioned as no specific test set or study is described.

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

• Cannot be provided. This device is a mechanical spinal fixation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. As above, this is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth establishment is described in the document. For a mechanical device, ground truth would typically relate to biomechanical testing standards (e.g., fatigue, pull-out strength, stiffness) or clinical outcomes, but these are not cited in this summary.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set as this is not an AI/algorithmic device.

9. How the ground truth for the training set was established

• Cannot be provided. As above, no training set or ground truth establishment for a training set is mentioned.

Summary based on the provided text:

The ZPLATE-ATL™ Anterior Spinal Fixation System received 510(k) clearance based on its substantial equivalence to itself, meaning it was likely a modification or re-submission for a device already on the market or previously cleared. The FDA's letter confirms that the devices are substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through comparisons of technological characteristics and intended use. The document provided does not contain details of specific performance testing, clinical studies, or acceptance criteria in the manner one would see for novel devices or those requiring a de novo classification.

Ask a specific question about this device

The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided text is a 510(k) premarket notification for the ZPLATE-ATL™ Anterior Spinal Fixation System. It focuses on the substantial equivalence of the device to itself, indicating that it is a modification or re-filing of an already cleared device.

Therefore, this document does not contain information about acceptance criteria and a study proving a device meets those criteria, as it would for a novel device. The FDA's letter explicitly states: "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself." This means the current submission is for an already cleared device, possibly with minor modifications that do not warrant new clinical studies or the establishment of new performance acceptance criteria.

To answer your request, if this were a submission for a new device, the information you're asking for would typically be found in sections detailing performance data, clinical studies, or non-clinical tests. This document instead states that the device is substantially equivalent to itself, which bypasses the need for the kind of studies you describe in your prompt.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

Ask a specific question about this device