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The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. The DePuy PULSE Anterior Cervical In-Line Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.

The provided text describes a 510(k) summary for the DePuy PULSE™ Anterior Cervical In-Line Plate System, which is a medical device for anterior screw fixation of the plate to the cervical spine. The "study" proving the device meets acceptance criteria refers to non-clinical mechanical tests, as no clinical tests were performed.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the "acceptance criteria was/were met" for all tests without providing the specific numerical values of the acceptance criteria themselves.

Study Details (Non-Clinical Mechanical Testing)

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: The tests are described as "mechanical tests," implying they were conducted in a laboratory setting. The text does not provide information about the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F-1717) and measurements from the testing equipment, not by human expert consensus or clinical assessment.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Mechanical test results are typically objective measurements, not subjective evaluations requiring adjudication.

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:

• MRMC Study: No. The device is an Anterior Cervical Plate System, a physical implant, not an AI-assisted diagnostic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this device's performance is based on engineering standards and measurements from mechanical testing equipment, specifically in accordance with ASTM F-1717 for spinal implant constructs in a vertebrectomy model.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is a physical implant, and the "study" concerns non-clinical mechanical safety and performance, not machine learning model training.

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

• Ground Truth for Training Set: Not applicable.

In summary, the provided document focuses on the non-clinical mechanical testing of a physical medical implant (an anterior cervical plate system) to demonstrate its substantial equivalence to predicate devices. It does not involve AI, human expert readings, or clinical studies.

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