(71 days)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology consists of new interbody implants that are provided sterile and are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion.
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The interbody device is a line extension to add Titan nanoLOCK™ Surface Technology to recently cleared Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021). The subject interbody incorporates Titan Surface Technologies™, where superior and inferior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic roughened surface with nano-scale features. nanoLOCK Surface Technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.
This is a medical device, not an AI/ML device. The provided text describes the regulatory submission for the "Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology," which is an implantable intervertebral body fusion device.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, and ground truth establishment is not applicable in this context. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and biocompatibility testing, not AI/ML performance.
However, I can provide information based on the performance data section of the document, which outlines the verification tests conducted to demonstrate the device's performance characteristics:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide "reported device performance" in terms of numerical results for each test. Instead, it lists the types of verification tests conducted. The underlying assumption for substantial equivalence is that the device met the established acceptance criteria for each test according to the respective ASTM standards or internal protocols, demonstrating comparable safety and effectiveness to the predicate devices.
Here's a re-interpretation of the requested table, focusing on the type of performance evaluated:
| Acceptance Criteria Category (Derived from Test Purpose) | Reported Device Performance (Implied from successful testing) |
|---|---|
| Static and Dynamic Compression Strength (per ASTM F2077-18) | Device demonstrated adequate mechanical strength under static and dynamic compression loads, comparable to predicate devices. |
| Static and Dynamic Compression Shear Strength (per ASTM F2077-18) | Device demonstrated adequate mechanical strength under static and dynamic compression shear loads, comparable to predicate devices. |
| Subsidence Resistance (per ASTM F2267-04(2018)) | Device demonstrated acceptable resistance to subsidence into vertebral endplates, comparable to predicate devices. |
| Expulsion Resistance | Device demonstrated acceptable resistance to expulsion from the intervertebral space, comparable to predicate devices. |
| Wear Debris Generation (per ASTM F1877 (2016)) | Device demonstrated acceptable levels of wear debris generation, comparable to predicate devices. |
| MRI Safety and Compatibility (per ASTM 2503-20, ASTM F2182-19e, ASTM 2052-21, F2213-17, F2219-07) | Device demonstrated acceptable MRI safety characteristics (e.g., heating, artifact, force, torque) consistent with labeled MRI conditions. |
| Titan nanoLOCK™ Surface Technology Performance | In-vitro studies demonstrated the ability of the nano-textured features to elicit an endogenous cellular and biochemical response. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of devices tested) for each mechanical or physical test. These tests are typically conducted in a laboratory setting on a representative number of devices and device configurations to ensure statistically sound results. Data provenance would be from internal Medtronic laboratories or accredited third-party testing facilities, likely in the US or similar regulatory environments. The data is prospective for the purpose of the 510(k) submission, meaning the tests were specifically designed and performed for this device to generate the required performance 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)
This is not applicable as the device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on medical data. Ground truth for mechanical testing would be the physical measurements and observations made during testing according to standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies, not the mechanical and material testing of physical medical devices.
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 a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical and physical tests, the "ground truth" is established by:
- Physical measurements and data acquisition: Using calibrated instruments and established test methods to measure parameters like load, deformation, wear, etc.
- Adherence to recognized standards: Compliance with ASTM standards (e.g., F2077, F2267, F1877, MRI safety standards) which define precise methodologies and sometimes acceptance criteria.
- In vitro cellular response: For the nanoLOCK™ surface, in vitro studies demonstrated the biological response, with the "ground truth" being the observed cellular and biochemical reactions under controlled laboratory conditions.
8. The sample size for the training set
Not applicable. This concept pertains to AI/ML software development.
9. How the ground truth for the training set was established
Not applicable. This concept pertains to AI/ML software development.
§ 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.