(64 days)
The KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI Tesera SA ALIF System is a standalone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.
The Kyocera Medical Technologies, Inc. Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System is a change to the FDA cleared Kyocera S128 Anterior Lumbar Interbody Fusion (ALIF) System (Ti6Al4V and PEEK cages, Cover Plate, screws and instruments; K131122. K140106. and K180502). Only the Ti6Al4V cages are relevant to this application which describes a change in manufacturing and material standard. There are no other changes in cage dimensions (L, W, H and lordosis), sterilization, packaging or shelf-life. The new system will be marketed as the Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System ("Tesera SA ALIF System") and will include Ti6Al4V cages only.
The Tesera SA ALIF System includes cages of a variety of lengths, widths, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. Tesera SA ALIF System cages are standalone when implanted with the Cover Plate and screws with the exception of implants ≥20° which require supplemental fixation.
The Ti6Al4V is compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
The Tesera SA ALIF System cages that are the subject of this application are gamma sterilized.
The system also includes the previously FDA cleared Cover Plate and screws; previously FDA cleared and new instruments to allow for implant determination, trialing and disc preparation. New instruments are manufactured from stainless steels compliant with ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
This document describes the KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, which is a medical device. The information provided is primarily for a 510(k) premarket notification, indicating the device is substantially equivalent to previously cleared devices. Therefore, the "acceptance criteria" and "device performance" are primarily benchmarks against predicate devices and adherence to relevant ASTM standards, rather than clinical trial results with specific performance metrics like sensitivity or specificity for AI.
Here's an analysis based on the provided text, focused on aspects relevant to device performance and study methodology, even if not directly an "AI" study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Compliance with ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices (Dynamic Shear Compression) | Successful dynamic shear compression testing conducted. |
| Compliance with ASTM E8/E8M-16 Standard Test Methods for Tension Testing of Metallic Materials | (Not explicitly stated as a test conducted for this submission, but implies material properties meet this standard) |
| Compliance with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion (for Ti6Al4V material) | Cages are manufactured to ASTM F2924. |
| Manufacturing change validation | Manufacturing change has been validated. |
| Substantial equivalence to predicate devices (K131122, K140106, K180502) in terms of indications for Use, dimensions, sizes, packaging, and sterilization. | The Tesera SA ALIF System has the same Indications for Use as the predicate devices. The cages are additively manufactured; have the same dimensions and sizes, are packaged and gamma sterilized the same as the predicate cages. |
| Absence of new or different issues of safety or effectiveness associated with the new cages. | The change in manufacturing and material standard do not result in new or different issues of safety or effectiveness associated with the new cages. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a "test set" in the context of an AI device. The performance evaluation is based on bench testing of the device itself and comparison to predicate devices. Therefore, a sample size for a test set of patient data, data provenance, or retrospective/prospective nature is not applicable here. The "sample" in this context refers to the manufactured devices tested. The document does not specify the exact number of devices or test specimens used for the bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI study involving human expert ground truth for interpretation of medical images or data. The "ground truth" for this device's performance is established by engineering standards and direct physical testing of the device.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication process described for the bench testing. Compliance with standards and successful performance are determined by the test results themselves.
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 device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or AI device. The device itself (an interbody fusion system) is "standalone" in the sense that it doesn't require "additional supplementary fixation" in most cases, but this is a physical characteristic, not an algorithmic performance metric.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's technical performance is based on:
- Established engineering standards: ASTM F2077-18, ASTM E8/E8M-16, ASTM F2924.
- Physical properties and performance characteristics measured during bench testing (e.g., dynamic shear compression).
- Comparison to previously cleared predicate devices based on design, materials, manufacturing processes, and intended use.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.