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The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:

1. Spondylolisthesis
2. Fracture
3. Spinal stenosis
4. Tumor
5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

The Synthes Anterior Cervical Vertebrae Plate System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with expansionhead screws and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from titanium.

The provided text is a 510(k) premarket notification for the Synthes Anterior CSLP System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics in the way a PMA (Pre-Market Approval) or de novo submission would.

Therefore, the document does not contain the detailed information required to answer many of your questions regarding acceptance criteria, specific study design, sample sizes, expert involvement, or statistical analysis of device performance.

Here's an analysis based on the available information:

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

• Not Applicable. The document explicitly states: "Information on the performance of the subject device compared to the performance of previously cleared spinal systems with similar indications has been provided." It does not present specific acceptance criteria or performance metrics for the Synthes Anterior CSLP System itself. The basis of clearance is "substantial equivalence" to predicate devices, implying that its performance is considered equivalent to devices already on the market.

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

• Not Applicable. No specific test set or clinical study data is detailed in the provided documentation for this 510(k) submission. The clearance is based on comparison to predicate devices, which typically involves demonstrating similar material properties, design, and intended use.

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. As no specific clinical test set data is provided, there is no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No test set data or adjudication method 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

• Not Applicable. This device is a spinal fixation system, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this submission.

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

• Not Applicable. This device is a spinal fixation system and does not involve any algorithms in the manner implied by this question.

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

• Not Applicable. No ground truth data is presented for this device in the context of clinical performance. The "ground truth" for a 510(k) in this context is often the established safety and effectiveness of the predicate device(s) through their prior marketing.

8. The sample size for the training set

• Not Applicable. As this is a medical implant and not a learnable algorithm, there is no "training set."

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

• Not Applicable. See point 8.

In summary:

The provided document is a 510(k) Premarket Notification for a spinal fixation system. A 510(k) relies on demonstrating "substantial equivalence" to a predicate device rather than conducting new, extensive clinical trials with pre-defined acceptance criteria and performance metrics. Therefore, the detailed study information, acceptance criteria, and performance data typically associated with a PMA or de novo submission are not present in this document. The "study" referenced is the comparison of the device's design, materials, and indications for use to already cleared predicate devices.

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