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The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

This document is a 510(k) summary for the CAPSTONE® Spinal System, seeking to expand its indications for use. It's important to note that this is a medical device submission, not a submission for an AI/ML powered device, therefore, many of the requested categories (e.g., ground truth, experts, training sets, MRMC studies) are not applicable in this context. The acceptance criteria for this type of submission are primarily focused on demonstrating substantial equivalence to previously cleared devices and safety/effectiveness for the expanded indication through clinical and non-clinical data.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of device performance testing. The "clinical data" mentioned refers to retrospective studies.
• Data Provenance: "Published retrospective clinical data" - the country of origin is not specified, but the submission is to the US FDA. The data is retrospective.

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

• Not Applicable. This submission is for a physical medical device, not an AI/ML powered device where expert-established ground truth for a test set is typically required. The "truth" here is established from clinical outcomes observed in the retrospective studies.

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

• Not Applicable. As above, this concept does not apply to this type of device submission. Clinical outcomes from the retrospective data would typically be reviewed and adjudicated by treating physicians in the original studies, but this level of detail is not provided 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

• No. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

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

• Not Applicable. This is a physical spinal implant, not an algorithm.

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

• The "ground truth" for the expanded indication is based on outcomes data from the "published retrospective clinical data" on the CAPSTONE® Spinal System and similar interbody cages. The key finding from this data was that using these cages for deformity conditions posed "no new risks to patients."

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a "training set."

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

• Not Applicable. As above, a training set is not relevant for this type of device.

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The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.

The provided text is a 510(k) summary for the CAPSTONE® Spinal System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of clinical performance or device accuracy in the way an AI/ML device would.

Therefore, many of the requested categories, such as "acceptance criteria," "device performance," "sample size for test set," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set," are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted from the provided text, aligning with the spirit of the request where possible, and explicitly stating when information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is not based on a clinical test set for performance evaluation but rather a comparison to an existing predicate device. The "test" here refers to non-clinical tests for cleaning and sterilization, not a clinical study on patient data.

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

• Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.

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

• Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.

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 a surgical implant, not an AI/ML diagnostic tool or an assistive technology for human readers.

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

• Not Applicable. This device is a surgical implant, not a standalone algorithm.

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

• Not Applicable. Pertains to clinical performance studies. The "ground truth" for this submission is the established performance and safety profile of the predicate device.

8. The sample size for the training set

• Not Applicable. This device is a surgical implant, not an AI/ML model for which a training set would be used.

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

• Not Applicable. This device is a surgical implant, not an AI/ML model.

Summary of the Study (or Basis for Clearance):

The "study" in this context is a premarket notification (510(k)) submission designed to demonstrate that the CAPSTONE® Spinal System is substantially equivalent to a legally marketed predicate device (also the CAPSTONE® Spinal System, implying an updated version or minor modification).

• Objective: To demonstrate that the subject device is as safe and effective as the predicate device, thereby not requiring a Premarket Approval (PMA) application.
• Methodology: The sponsor provided documentation (non-clinical tests and comparative analysis) to show that the subject device shares the same indications for use, intended use, performance specifications, and technological characteristics as the predicate device. The only noted change was the addition of a new threaded inserter instrument.
• Testing Conducted: Cleaning and sterilization validation activities were performed for the CAPSTONE® Spinal System, specifically addressing the new instrument, to ensure appropriate instructions were provided in the labeling.
• Conclusion: The FDA reviewed the submission and concurred that the device is substantially equivalent to the predicate device, allowing it to be marketed.

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