(143 days)
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.
The provided document describes the 510(k) Pre-market Notification for the TranS1® Interbody Fusion System. This submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve a study related to AI or a software device, and therefore many of the requested criteria are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a physical interbody fusion implant, not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" are related to mechanical performance for safety and effectiveness as defined by ASTM standards.
| Test | Standard | Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|---|---|
| Static Compression | ASTM F2077-11 | Meets or exceeds standard requirements | Met or exceeded requirements |
| Static Compression Shear | ASTM F2077-11 | Meets or exceeds standard requirements | Met or exceeded requirements |
| Static Torsion | ASTM F2077-11 | Meets or exceeds standard requirements | Met or exceeded requirements |
| Subsidence | ASTM F2267-04 | Meets or exceeds standard requirements | Met or exceeded requirements |
| Expulsion | N/A | N/A (Standard not specified) | Met or exceeded requirements |
| Dynamic Compression | ASTM F2077-11 | Meets or exceeds standard requirements | Met or exceeded requirements |
Note: The document states "All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards." This indicates that the device's performance satisfied the established benchmarks for mechanical integrity.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The "test set" in this context refers to the samples of the TranS1® Interbody Fusion System that underwent mechanical testing. The document does not specify the exact number of units tested for each mechanical test.
- Data Provenance: The mechanical testing was "performed per ASTM standards," implying controlled laboratory conditions. There is no information regarding country of origin for "data" in the sense of patient data, as this was not a clinical study. It was a pre-market submission based on engineering and materials testing. The study was not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable (N/A): For mechanical testing of an implant, the "ground truth" is defined by the objective physical properties and performance against established ASTM standards. There are no human experts involved in establishing a "ground truth" for interpretive data in this type of submission. The standards themselves, and the engineers verifying compliance, serve this role.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical readings or image analysis. This is not relevant for mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Not Applicable (N/A): An MRMC study is a clinical study format involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a physical medical implant and does not involve AI or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable (N/A): This question pertains to AI algorithm performance. The TranS1® Interbody Fusion System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Standards and Performance Metrics: The "ground truth" for the device's performance is adherence to the validated mechanical test standards (ASTM F2077-11, ASTM F2267-04, etc.) and meeting the predefined requirements within those standards. This is an objective and quantitative ground truth established by engineering principles.
8. The Sample Size for the Training Set
- Not Applicable (N/A): There is no "training set" in the context of mechanical testing for a medical implant like this. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): As there is no training set, this question is not applicable.
§ 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.