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The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation

The SeaSpine Regatta Lateral System is an intervertebral body fusion device (IBD) with large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacer has a bulleted insertion end for ease of implantation and tantalum markers to allow easier radiological assessment of the spacer position and orientation. The spacers are manufactured from PEEK (ASTM F2026) with radiographic markers manufactured from tantalum (ASTM F560), with a one-micron thick surface of commercially pure (CP) titanium (ASTM F67), and sterile packaged. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.

Based on the provided text, the document describes a 510(k) Premarket Notification for the SeaSpine Regatta Lateral System. This type of submission to the FDA focuses on establishing substantial equivalence to a predicate device, rather than proving efficacy or safety through new clinical studies measuring specific performance criteria against predefined acceptance thresholds.

Therefore, the requested information about acceptance criteria, device performance, sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving the device meets acceptance criteria is not applicable to this specific submission.

The document explicitly states:

• "Non-Clinical Testing" outlines mechanical performance, packaging, shipping, and sterilization tests. These are engineering and material validation tests, not clinical performance studies where the device's diagnostic or therapeutic accuracy is measured against patient outcomes or expert consensus.
• "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This directly confirms that no clinical studies were performed to establish performance metrics against acceptance criteria for this 510(k) submission.

Here's a breakdown of why each point is not applicable to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. Acceptance criteria for clinical performance are not mentioned because no clinical performance was assessed. The mechanical tests (compression, shear, subsidence, expulsion) have their own engineering acceptance criteria, but these are not for clinical "performance" in the sense of an AI algorithm's accuracy or a diagnostic device's sensitivity/specificity.
2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was adjudicated.
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 is a medical device (intervertebral body fusion device), not an AI-assisted diagnostic tool. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

In summary, the provided document clearly states that substantial equivalence for the SeaSpine Regatta Lateral System was determined based on non-clinical testing and comparison to predicate devices, not on new clinical performance data or studies involving human readers or AI algorithms.

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