(106 days)
The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 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. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
These patients should be skeletally mature and six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforminal approach.
Medtronic Navigated Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consist of Additively Manufactured (AM) titanium spacers of various lengths, and heights to accommodate patient. These subject implants can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.
The subject Adaptix™ Interbody System Fusion devices are available in a variety of lengths and heights for treatment in lumbar interbody fusion procedures. The subject device is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The design incorporates "honeycomb windows" through the interbody device to permit bone growth through the implant. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device incorporates Titan Surface Tecnologies™ including a macro-rough surface on the superior and inferior surfaces of the device along with the is entire device being treated with nanoLOCK™ Surface Technology (MMN™) to improve fixation to the adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.
The subject device is manufactured from Titanium-4 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI) powder in accordance with ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (Extra Low Interstitial) with powder bed fusion.
The Navigated Disc Prep instruments are non-sterile, reusable surgical instruments that are intended to be used to facilitate a discectomy and placement of implants during spinal surgery procedure. The subject devices are compatible with the subject Adaptix™ Interbody System and existing CAPSTONE® Spinal System and are also compatible with the StealthStation. These devices are offered in non-sterile form and are reusable. These subject devices are manufactured from stainless steel and silicone.
The provided text describes a 510(k) premarket notification for the "Adaptix Interbody System with Titan nanoLOCK Surface Technology" and "Navigated Disc Prep Instruments." This document focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than providing detailed clinical study results with acceptance criteria common for entirely novel medical devices or AI/software as a medical device (SaMD).
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies is not applicable to this type of submission. This 510(k) summary focuses on demonstrating mechanical, material, and functional equivalence rather than clinical performance based on diagnostic accuracy or reader improvement.
However, I can extract information related to the device performance testing and describe what details are available from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | Static and Dynamic Testing (Worst-case construct) | In accordance with ASTM F2077-18 (Standard Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04(R18) (Standard Test Method for Measuring Load Displacement Properties of Cortical Bone-Cancellous Bone Blocks under Compression). Specific acceptance criteria are not detailed in the provided text, but compliance with these standards typically implies meeting defined limits for strength, fatigue life, and subsidence resistance for intervertebral body fusion devices. | Testing was performed on the worst-case construct and determined to be compliant with ASTM F2077-18 and ASTM F2267-04(R18). This implies the device met the requirements of these standards. |
| Bone Screw Configurations (Worst-case) | In accordance with ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws). Specific acceptance criteria are not detailed in the provided text, but compliance implies meeting mechanical property requirements for bone screws. | Additionally tested per ASTM F543-17, implying compliance. | |
| Particulate and Wear Analysis (Dynamically loaded specimens) | In accordance with ASTM F1877-16 (Standard Practice for Characterization of Particles). Specific acceptance criteria (e.g., maximum particle count, size distribution, or material loss) are not detailed in the provided text, but compliance implies acceptable wear and particulate generation. | Conducted per ASTM F1877-16, implying acceptable particulate and wear characteristics. | |
| Navigated Disc Prep Instruments including Navigated Rotating Shavers | Navigation Accuracy Analysis | Not detailed in the provided text, but would typically involve quantitative metrics for positional and orientational accuracy relative to a target or ground truth in 2D and 3D space. | Confirmed navigated instrument accuracy in both 2D and 3D space. |
| Anatomical Simulated Use | Not detailed in the provided text, but would typically involve criteria for proper functionality, fit, and maneuverability under simulated surgical conditions. | Confirmed instrument functionality under expected use conditions. | |
| Navigation Simulated Use | Not detailed in the provided text, but would likely include criteria for reliable system performance, tracking stability, and user interface responsiveness during simulated navigation. | Confirmed navigation system functionality under expected use conditions. | |
| CAD Model Evaluation | Verification that the CAD models accurately reflect the physical devices and are correctly represented in the application software. Criteria would be direct comparison and measurement against physical parts. | Verified that the CAD models are accurately reflected in the application software. | |
| Implant/Instrument Mating Conditions | Verification that instruments can be assembled correctly with appropriate devices and implants according to their intended use (e.g., proper fit, secure connection). | Verified that the instruments can be assembled with the appropriate devices according to their intended use. | |
| Spine Tools Package Functional Testing | Verification that the Spine Tools package met the required interface needs. Criteria would involve successful execution of all functions and proper interaction with the StealthStation™ System. | Verified that the Spine Tools package has met the required interface needs. |
2. Sample size used for the test set and the data provenance:
- Adaptix Interbody System: The document mentions "testing was performed on the worst-case construct" for static and dynamic testing and bone screw configurations. This usually implies a limited sample size representative of the most challenging conditions (e.g., largest implant, specific material composition, specific screw configuration) for mechanical integrity testing. Specific numbers are not provided. The data provenance is laboratory testing of manufactured devices.
- Navigated Disc Prep Instruments: No specific sample sizes for instrument testing are provided in the summary. The testing appears to be primarily benchtop and simulated use ("Anatomical Simulated Use," "Navigation Simulated Use"). The data provenance is laboratory testing of instruments and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The described tests are primarily physical and mechanical performance tests for an interbody fusion device and functional tests for surgical instruments. These do not involve interpretation of medical images or patient data requiring expert ground truth establishment in the way an AI/CADe device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As the tests are physical, mechanical, and functional, there is no need for expert adjudication. Results are typically determined by measurement against scientific standards.
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. The devices in question are an interbody fusion device and navigated surgical instruments, not an AI/CADe diagnostic or interpretive device. Therefore, no MRMC studies comparing human reader performance with and without AI assistance were conducted or are relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The devices are physical implants and surgical instruments. While the navigated instruments use software (StealthStation™ System), the performance described is primarily system functionality and accuracy in a surgical context, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Adaptix Interbody System: The "ground truth" for these tests are the established ASTM standards (F2077-18, F2267-04(R18), F543-17, F1877-16) which define the expected mechanical properties, fatigue limits, and acceptable wear characteristics for intervertebral body fusion devices.
- Navigated Disc Prep Instruments: The "ground truth" for navigation accuracy would be known anatomical or model coordinates against which the device's measured positions are compared. For functional tests, the "ground truth" is the intended function and design specifications of the instruments and the StealthStation™ system.
8. The sample size for the training set:
- Not Applicable. These are physical medical devices and surgical instruments, not AI/ML algorithms that require a training set of data.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is involved for these types of devices.
§ 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.