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The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.

The DePuy Pulse Cervical Cage System is designed for use as a cervical intervertebral body fusion device. The implant devices are available in various geometries and sizes to accommodate patient anatomy. The implant devices are manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and also contain tantalum wires per ASTM F-560. The DePuy Pulse Cervical Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device, the DePuy Pulse Cervical Cage System, and its 510(k) summary for FDA clearance. However, the document does NOT contain information about acceptance criteria or a study proving the device's performance based on such criteria in a clinical setting with human subjects.

The "Non-clinical Test Summary" section mentions mechanical tests that were conducted and that "The acceptance criteria was/were met." This refers to engineering and mechanical performance (e.g., strength, durability) of the implant itself, not patient outcomes or clinical effectiveness thresholds.

Therefore, many of the requested details cannot be extracted from the provided text because they pertain to clinical performance studies, which were explicitly stated as not performed.

Here's a breakdown of what can and cannot be answered based on the provided input:

Acceptance Criteria and Device Performance Study Details for the DePuy Pulse Cervical Cage System

The provided 510(k) summary for the DePuy Pulse Cervical Cage System (K120517) details non-clinical mechanical testing to establish substantial equivalence to predicate devices. It explicitly states, "No clinical tests were performed." Therefore, information regarding clinical performance acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance in a clinical context cannot be provided.

The acceptance criteria mentioned in the document relate to the mechanical properties of the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable for clinical performance as "No clinical tests were performed." For non-clinical mechanical testing, specific sample sizes are not detailed in the summary, but such tests typically use a defined number of device units.
• Data Provenance: Not applicable for clinical performance. The mechanical testing data would originate from the manufacturer's laboratory or a contracted testing facility.

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

Not applicable, as no clinical tests were performed to establish ground truth for patient outcomes.

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

Not applicable, as no clinical tests were performed requiring adjudication of results in a clinical context.

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 an intervertebral body fusion device (an implant), not an AI/imaging diagnostic tool. No clinical studies, let alone MRMC studies, were performed.

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

Not applicable. This device is an intervertebral body fusion device (an implant), not an AI/software algorithm.

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

Not applicable for clinical performance. For the mechanical tests, the "ground truth" is defined by the specified ASTM standards and their associated pass/fail criteria (e.g., maximum load before failure, deformation limits).

8. The sample size for the training set

Not applicable, as "No clinical tests were performed" and no machine learning algorithm is involved.

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

Not applicable.

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