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The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.

This 510(k) submission for the SSP Vertebral Body Replacement describes a mechanical device, not an AI/ML-driven device or diagnostic tool. Therefore, the typical acceptance criteria and study designs associated with AI performance (like sensitivity, specificity, AUC, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "acceptance criteria" for this type of medical device primarily revolve around mechanical safety and efficacy demonstrating substantial equivalence to predicate devices, as determined through a combination of:

• Mechanical Testing: To ensure the device can withstand the physiological loads and stresses it will experience in the human body.
• Biocompatibility Testing: To ensure the materials used are safe for implantation.
• Design and Material Equivalence: Comparison to legally marketed predicate devices.
• Clinical Justification/Indications for Use: Alignment with established medical practice and predicate device usage.

Based on the provided document, here's an attempt to address the prompts by reinterpreting them for a mechanical device submission where applicable, and explicitly stating when information is not present or relevant:

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for SSP Verteral Body Replacement

1. Table of Acceptance Criteria and Reported Device Performance

Note: This 510(k) summary does not contain detailed mechanical test results or biocompatibility data. For mechanical devices, proving "substantial equivalence" to legally marketed predicate devices (which have already met safety and effectiveness standards, including mechanical performance) often forms the primary basis for "acceptance." The FDA's letter states the device "is substantially equivalent...to legally marketed predicate devices."

Regarding the remaining questions, which are highly specific to AI/ML device evaluations:

• 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. This is a mechanical implant, not an AI/ML diagnostic or predictive device that uses test sets of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of AI/ML diagnostic performance is not relevant for this mechanical device. The "ground truth" for this device would be its mechanical integrity and biocompatibility, typically established through laboratory testing and material science principles, or clinical outcomes for predicate devices, not expert image review.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI/ML performance is involved.
• 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. An MRMC study is designed for AI-assisted diagnostic tasks, not for evaluating a spinal implant.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML context. For this device, "ground truth" is established through engineering principles, material standards, and clinical experience with predicate devices. This includes demonstrating appropriate mechanical strength, fatigue resistance (not detailed in this summary, but would be expected in the full submission), and biological compatibility.
• 8. The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, there is no training set.
• 9. How the ground truth for the training set was established: Not applicable. As above, no training set.

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The SSP Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The SSP Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.

The SSP Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods, pedicle screws and transverse links. To enable close conformance to patient anatomy, pedicle screws and rods are available in various lengths, diameters, and/or contours. A series of manual surgical instruments (not a subject of this submission) intended to assist the insertion and placement of the implants are provided in an instrument tray.

This submission is a 510(k) premarket notification for a Class II medical device, the SSP Pedicle Screw System. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria and a study proving device performance in the context of clinical efficacy, reader studies, and ground truth establishment is not typically found in a standard 510(k) summary for this type of device.

510(k) submissions for pedicle screw systems usually focus on:

• Substantial Equivalence: Comparing the new device's indications for use, technological characteristics, and performance data (often mechanical testing) to a predicate device.
• Mechanical Testing: Demonstrating that the device meets established ASTM or ISO standards for strength, fatigue, and other biomechanical properties.

Based on the provided text, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance or diagnostic accuracy, as this is a surgical implant. The acceptance criteria for a 510(k) of this nature would primarily be the demonstration of substantial equivalence to a predicate device and satisfactory mechanical testing results (which are not detailed in this summary).
• Reported Device Performance: The document states, "Specialty Spine Products, LLC has submitted information to demonstrate that... the SSP Pedicle Screw System is substantially equivalent in indications and design principles to predicate devices..." This "performance" is in the context of equivalence, not a clinical outcome measure described by a specific metric (sensitivity, specificity, etc.).

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 for clinical studies in this 510(k). This is not a diagnostic device or an AI-based system that would typically have a "test set" in the sense of patient data for performance evaluation. If a "test set" were to be considered, it would refer to the samples used in mechanical testing (e.g., number of screws tested for fatigue), but this specific information is not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a surgical implant, not a diagnostic tool requiring expert interpretation of results to establish ground truth for a test set.

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

• Not applicable. This relates to clinical or diagnostic study outcomes, which are not detailed here.

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 does not involve human "readers" or AI assistance.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable. The "ground truth" for a medical implant like this is usually established through adherence to engineering design specifications, material properties, and mechanical performance standards, compared against predicate devices and relevant ASTM/ISO standards. Clinical efficacy would be demonstrated in post-market surveillance or larger clinical trials, which are beyond the scope of a 510(k) that establishes substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI device for this submission.

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

• Not applicable. There is no "training set" for an AI device.

Summary of available information relevant to acceptance criteria and study:

The 510(k) summary provided mostly pertains to regulatory and administrative information, device description, intended use, and the declaration of substantial equivalence. The "study" mentioned is the submission of information to demonstrate substantial equivalence to predicate devices, which is the core requirement for a 510(k) clearance. This equivalence relies on comparing indications for use, technological characteristics (materials, design, manufacturing methods), and typically includes mechanical testing data (though not detailed here) to ensure the new device performs at least as safely and effectively as the predicate.

For devices like this, the "acceptance criteria" are predominantly those defined by FDA guidance documents for pedicle screw systems and relevant mechanical testing standards (e.g., ASTM F1717-96 for spinal implant constructs, ASTM F1798 for fatigue testing of pedicle screw systems), against which the device's mechanical performance would be evaluated to ensure it meets acceptable safety and integrity thresholds. The document explicitly states the FDA reviewed the information and "determined the device is substantially equivalent." This determination is the "proof" that the device meets the regulatory acceptance criteria for 510(k) clearance.

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