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When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.

The provided text describes a 510(k) premarket notification for the Blackstone PILLAR SA PEEK Spacer System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML medical device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable as this submission is for a physical medical implant device, not an AI/ML diagnostic or predictive system.

Here's a breakdown of what can be extracted from the provided text, and where the information is not present:

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

Not Applicable. This submission is for a physical medical implant, not an AI/ML device. The "performance" is demonstrated through substantial equivalence to predicate devices based on mechanical testing and similar design/materials, rather than meeting specific performance metrics against a defined ground truth as would be the case for an AI/ML algorithm.

The basis of substantial equivalence relies on:

• Mechanical performance data: This implies various engineering tests were conducted to ensure the device's structural integrity and functionality are comparable to predicate devices. Specific quantitative acceptance criteria and detailed performance results from these mechanical tests are not provided in this summary document.
• Equivalence in configuration and indications for use: The device's design, materials (PEEK-OPTIMA® LT1 with tantalum markers), and intended uses are similar to cleared predicate devices.

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

Not Applicable. As this is a physical medical implant, there is no "test set" of patient data or images in the context of an AI/ML device. The "testing" involved mechanical performance evaluations on the physical device itself.

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

Not Applicable. There is no "ground truth" in the AI/ML sense. The substantial equivalence relies on engineering standards and comparison to previously cleared devices.

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

Not Applicable. No human adjudication of a "test set" is described for this physical device submission.

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 not an AI-assisted device.

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

Not Applicable. This is not an AI algorithm.

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

Not Applicable. The "truth" for this device's safety and effectiveness is established through adherence to material standards (ASTM F-2026, ASTM F-560), mechanical testing results (implied, but not detailed), and a comparison of its design, materials, and intended use to legally marketed predicate devices already cleared by the FDA.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. See point 8.

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