(28 days)
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Palients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
MectaLIF Extension is a design modification to MectaLIF Posterior and Oblique (K110927) and MectaLIF Transforaminal (K120024). The bullet nose modification to the implant tip geometry creates a self-distracting feature which facilitates insertion of the implant into the disc space. MectaLIF Extension also includes intermediate sizes of MectaLIF Posterior and Oblique as well as new sizes of MectaLIF Oblique. The materials and indications for use are identical to the predicate devices. The materials are PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) and Tantalum (ISO 13782 / ASTM F 560). MectaLIF Transforaminal also has a Gear made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
The provided document describes the MectaLIF Extension, an intervertebral body fusion device. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document.
However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Axial Compression (ASTM F2077) | Performance equivalent to or better than predicate devices. | Similar performance to predicates; MectaLIF Extension determined not to be the worst case. |
| Dynamic Axial Compression (ASTM F2077) | Performance equivalent to or better than predicate devices. | Similar performance to predicates; MectaLIF Extension determined not to be the worst case. |
| Static Compression/Shear (ASTM F2077) | Performance equivalent to or better than predicate devices. | Similar performance to predicates; MectaLIF Extension determined not to be the worst case. |
| Dynamic Compression/Shear (ASTM F2077) | Performance equivalent to or better than predicate devices. | Similar performance to predicates; MectaLIF Extension determined not to be the worst case. |
| Subsidence Resistance (ASTM F2267) | Performance equivalent to or better than predicate devices. | Similar performance to predicates; MectaLIF Extension determined not to be the worst case. |
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 performance test. It states that "The testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited selection of devices representing the most challenging configurations. Data provenance (country of origin, retrospective/prospective) is not provided as this is a device performance test, not a clinical data study.
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 a mechanical performance study for an intervertebral body fusion device, not an AI device requiring expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or clinical data adjudication.
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 document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any study involving human readers with or without AI assistance. This is a 510(k) submission for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not for an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical performance tests, the "ground truth" (or reference for comparison) was established by the pre-defined acceptance criteria based on standards (like ASTM F2077, ASTM F2267), FDA guidance, and comparison to predicate device systems.
8. The sample size for the training set
Not applicable. This is not an AI device or a study involving a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device or a study involving a training set.
§ 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.