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The CAPSTONE CONTROL™ System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally. the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

The subject CAPSTONE CONTROL™ Spinal System adds 24-degree lordotic PEEK cages with tantalum markers to the existing CAPSTONE CONTROLTM Spinal System. Both the predicate sizes, and including the subject 24-degree lordotic cages, will also be provided with a commercially pure titanium coating (CP Ti) on the opposing, endplate-contacting sides of the implant. The titanium coated interbody cages will be branded as the CAPSTONE CONTROL PTC™ Spinal System (PTC = Pure Titanium Coating) to differentiate the coated cages from the uncoated CAPSTONE CONTROLTM Spinal System cages. The titanium coating is identical to the coating on the predicate CAPSTONE PTC™ Spinal System implants (Predicate #4).

The subject instruments include 24-degree lordotic cam spreader trials that correspond to the subject 24-degree lordotic cages. The predicate and subject cam spreader trials, and other instruments used to facilitate the implantation of the uncoated CAPSTONE CONTROL™ Spinal System cages, will also be used with the CAPSTONE CONTROL PTC™ Spinal System.

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems consist of interbody fusion 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal System cages are available in heights of 8mm to 18mm, lengths of 22mm, 27mm, and 32mm, and widths of 9mm or 10mm. The implants will be available with 0°, 6°, 12°, 18°, or 24° of lordosis. The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems also include cam spreader trials and a variety of instruments to help facilitate the implantation of the interbody fusion cages.

This document describes the premarket notification (510(k) K171107) for the Medtronic Sofamor Danek CAPSTONE CONTROL™ Spinal System and CAPSTONE CONTROL PTC™ Spinal System. While the document outlines various tests conducted, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a study in the way a diagnostic AI/ML device would. The information provided is primarily related to mechanical and material performance testing for an intervertebral body fusion device.

Therefore, the requested information elements (especially those related to diagnostic performance like sensitivity, specificity, reader studies, ground truth establishment, training/test set sizes, and expert qualifications) are not applicable to this type of device and submission.

However, I can extract the relevant information from the provided text regarding the performance data and "acceptance criteria" as they are described within the context of a medical implant device submission.

Here's a breakdown based on the provided text, addressing elements that are applicable and noting where others are not:

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

The document states that "The pre-determined acceptance criteria, established using predicate test data, were met for all tests." and "The subject 24-degree lordotic CAPSTONE CONTROL PTC™ implants met the pre-determined acceptance criteria, established using predicate test data, for all tests." Specific numerical acceptance criteria and reported device performance values are not detailed in this summary document, only that the criteria were met. The tests performed are listed.

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

• Mechanical and Material Testing: The document does not specify the exact sample size for each test (e.g., number of coating samples, number of implants for mechanical testing). It states "worst case subject 24-degree lordotic coated CAPSTONE CONTROL PTC™ implants" were tested and the "subject 24-degree lordotic uncoated CAPSTONE CONTROLTM implants were also tested" for expulsion.
• Cadaver Labs: The number of cadavers or surgical procedures performed is not specified.
• Data Provenance: Not specified. This type of engineering and bench testing is typically conducted in a laboratory setting. It is not patient data.

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 is not an AI/ML diagnostic device; therefore, no "ground truth" in the diagnostic sense was established by experts for a test set.
• Cadaver Labs: "Independent surgeons" were involved in the design validation, but their number and specific qualifications are not detailed beyond being "surgeons."

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

• Not Applicable. No diagnostic test set requiring adjudication was used.

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/ML diagnostic device requiring a MRMC study.

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

• Not Applicable. This is not an AI/ML diagnostic device.

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

• Not Applicable (in the diagnostic sense). For the mechanical and material tests, the "ground truth" or reference for acceptance criteria was established using "predicate test data" and compliance with recognized ASTM and ISO standards. For the cadaver labs, the "ground truth" was whether the implants and instruments "functioned as intended" and "user needs were met" by independent surgeons.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML diagnostic device. However, "predicate test data" was used to establish acceptance criteria, which could be seen as a form of "training data" for defining acceptable performance ranges based on previously cleared devices. The exact sample size of this predicate data is not specified.

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

• Not Applicable (in the diagnostic sense). The "ground truth" for defining acceptance criteria was established through data and performance characteristics of legally marketed predicate devices and compliance with relevant industry standards (ASTM, ISO).

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The CAPSTONE CONTROL™ 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 nonoperative 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 CONTROL™ 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 CAPSTONE CONTROL™ Spinal System implants will be available in heights of 8mm to 18mm, lengths of 22mm, 27, mm, and 32mm, and widths of 9mm or 10mm. In addition, the implants will be available with 0°, 6°, 12°, and 18° of lordosis.

The CAPSTONE CONTROL™ Spinal System is an intervertebral body fusion device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set. However, it indicates mechanical testing was conducted. For such devices, samples typically refer to individual devices or components tested according to the standards. The provenance of this mechanical performance data would be laboratory testing performed by Medtronic Sofamor Danek, USA Inc.

The document does not provide details on the geographical origin of the data or whether it was retrospective or prospective, as it pertains to engineering-focused mechanical tests rather than patient studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies described are mechanical engineering tests rather than clinical or observational studies requiring expert consensus for ground truth. The "ground truth" here is defined by established engineering standards (ASTM F2077-11 and ASTM F2267-04) and FDA guidance.

4. Adjudication Method for the Test Set

This information is also not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are typical for clinical trials or image interpretation studies to resolve discrepancies in expert opinions. For mechanical testing, the results are objectively measured against predefined pass/fail criteria based on the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or diagnostic imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for demonstrating device performance was engineering standards and regulatory guidance. Specifically:

• ASTM F2077-11: Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
• FDA's Guidance document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007.

The "ground truth" for this submission is performance that meets the established mechanical requirements outlined in these standards and guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes the testing of a finished medical device against established standards, not the training of a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. There is no training set mentioned in the context of this device submission for machine learning.

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