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The Vu c.POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Vu c.POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/ or corticocancellous bone and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems.

The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Complete Cervical implants are to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant.

Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.

The SeaSpine Vu c-POD, Complete Cervical, and Zuma-C Systems are intervertebral fusion devices intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. All three system spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers. The Complete Cervical spacers also include titanium alloy and screws (ASTM F136), while Zuma-C includes titanium screws, as well as plates and set screws (ASTM F136).

Each system spacer is generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The systems are implanted via an anterior approach.

The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided document is a 510(k) Premarket Notification from the FDA regarding intervertebral body fusion devices. It focuses on the substantial equivalence of the new devices (SeaSpine Vu cPOD, Zuma-C, Complete Cervical) to previously marketed predicate devices.

Crucially, this document explicitly states that "determination of substantial equivalence is not based on an assessment of clinical performance data" and that "no mechanical testing was performed for the Vu c Pod and Complete Cervical systems," with Zuma-C relying on prior testing.

Therefore, based on the information provided in this document, it is not possible to outline acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or AI/software-based device evaluation. The submission primarily relies on the physical and material equivalence to existing devices.

The questions you've asked (about acceptance criteria for performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) are typical for the evaluation of medical devices that involve algorithms, AI, or clinical performance studies (e.g., diagnostic devices, imaging analysis software). This document does not describe such a study.

In summary, the document states:

• No clinical testing was performed for this submission.
• Substantial equivalence is not based on an assessment of clinical performance data.
• Mechanical testing was not performed for two of the devices, and for the third, previous testing was deemed sufficient.

Therefore, I cannot provide the requested information from this document. If you have a document that describes the clinical or performance study of an AI-powered or diagnostic medical device, I would be happy to analyze it for the details you've requested.

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Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.

Zuma-C is a stand-alone interbody fusion device composed of PEEK and titanium alloy with radiopaque markers, titanium screws and a locking cover. The screws are inserted through the device into adjacent vertebral bodies and the locking cover mates with the device, covering the screws. The device has an open central area for receiving bone graft material and is offered pre-assembled in a variety of heights and geometries to accommodate variations patient anatomy.

This document is a 510(k) summary for the Zuma-C™ interbody fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and pre-clinical testing for mechanical performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, ground truth establishment, and expert involvement are not applicable or not detailed in this submission.

Here's the information extracted and categorized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The studies performed were pre-clinical (benchtop) tests on device constructs, not data from a patient test set.
• Data Provenance: The data provenance is pre-clinical testing conducted by the manufacturer, SeaSpine, Inc. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.

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

• Not applicable. Ground truth as typically defined for diagnostic or prognostic devices with expert review is not relevant for this type of pre-clinical mechanical performance assessment. The "ground truth" here is adherence to established ASTM standards.

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

• Not applicable. Adjudication is not relevant for pre-clinical mechanical performance testing.

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 a medical device for spinal fusion, not an AI-powered diagnostic or decision support tool that would involve human readers.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" for these pre-clinical studies is defined by the performance requirements and testing methodologies outlined in the referenced ASTM standards (ASTM F2077, ASTM F2267, ASTM F1714, ASTM F1877). The goal was to show "substantial equivalence" to legally marketed predicate devices under these conditions.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "samples" would be the physical device constructs tested in the pre-clinical studies, but the concept of a "training set" doesn't apply.

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

• Not applicable. No training set for an AI/ML model was used.

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