(95 days)
The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. 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. 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 6 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 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
The Capstone Control™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone. The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The Capstone Control™ Interbody Fusion Devices are provided in various widths, heights, and lordosis, which can be inserted between two vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants also allows the implants to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
The provided text describes the regulatory clearance of a medical device (Capstone Control™ Spinal System), primarily focusing on its substantial equivalence to previously cleared predicate devices. It does not contain information about an AI/ML-based device or any study proving that a device meets acceptance criteria related to AI/ML performance (e.g., diagnostic accuracy, sensitivity, specificity).
The "Performance Data" section details mechanical testing, biocompatibility, bacterial endotoxin testing, and MRI compatibility of the physical implant device. These are standard performance tests for implantable medical devices, not for AI/ML algorithms.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as the document does not pertain to an AI/ML device.
If the request was based on a misunderstanding and the 'device' in question is the Capstone Control™ Spinal System itself, then the relevant information regarding its acceptance criteria and proof of meeting them can be extracted from the 'Performance Data' section.
Assuming you were asking about the physical device and its performance for the clearance, here's the information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static compression (ASTM F2077) | Not explicitly stated in the document (implied: meet or exceed predicate performance) | "The acceptance criteria was met for all tests." |
| Static compression-shear (ASTM F2077) | Not explicitly stated in the document (implied: meet or exceed predicate performance) | "The acceptance criteria was met for all tests." |
| Compression fatigue (ASTM F2077) | Not explicitly stated in the document (implied: meet or exceed predicate performance) | "The acceptance criteria was met for all tests." |
| Compression-shear fatigue (ASTM F2077) | Not explicitly stated in the document (implied: meet or exceed predicate performance) | "The acceptance criteria was met for all tests." |
| Subsidence (ASTM F2267) | Not explicitly stated in the document (implied: meet or exceed predicate performance) | "The acceptance criteria was met for all tests." |
| Bacterial Endotoxin | 20 endotoxin units (EU)/device pyrogen limit specification (as per ANSI/AAMI ST72 and USP ) | "Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit." |
| Biocompatibility | Materials considered biocompatible (due to long history of clinical use) | PEEK and Tantalum markers, stainless steel for trials. Considered biocompatible. |
| MRI Compatibility | Remains MR-Conditional | Determined not to present a new worst case to existing MR-Conditional predicate. Remains MR-Conditional. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for mechanical testing. Typically, mechanical tests involve a small, statistically valid number of samples (e.g., n=5 or n=10 per test) of the "worst-case" device configuration. For Bacterial Endotoxin Testing, "worst case subject interbody fusion devices" were used, implying a limited number.
- Data Provenance: Not specified regarding "country of origin" of data, but the testing was conducted to support a US FDA submission. The studies detailed are prospective bench tests performed on the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes mechanical, material, and chemical property testing of a physical device, not a diagnostic AI/ML device requiring expert ground truth for interpretation of medical images/data. The "ground truth" for these tests is based on established engineering standards (ASTM) and chemical/biological safety standards (ANSI/AAMI, USP).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are relevant for human interpretation or AI output evaluation where subjective or complex assessments are involved, typically in diagnostic or clinical studies. For bench testing, the results are objectively measured against defined criteria.
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:
- This question is not applicable. No MRMC study was performed as this is a physical medical implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This document does not describe an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical tests: Engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device performance.
- For bacterial endotoxin: Chemical/biological safety standards (ANSI/AAMI ST72, USP ).
- For biocompatibility: Historical clinical use of materials.
- For MRI compatibility: FDA guidance for MR environment (Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) and comparison to predicate device.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- This question is not applicable. There is no "training set" as this is not an AI/ML device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.