(127 days)
The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. Th DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.
The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.
The provided text describes the 510(k) summary for the Cervical Spinal Truss System (STS) Interbody Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than a clinical study evaluating human reader performance with or without AI.
Therefore, many of the requested criteria related to clinical studies, human readers, AI, and ground truth establishment are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Compression (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Static Compression Shear (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Static Torsion (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Axial Compression (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Compressive Shear (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Dynamic Torsion (per ASTM F2077) | Performed, results indicate substantial equivalence |
| Subsidence (per ASTM F2267-04) | Performed, results indicate substantial equivalence |
| Expulsion Testing (per industry accepted methodology) | Performed, results indicate substantial equivalence |
Note: The document only states that testing was "performed" and that the "minor differences that do exist do not raise any new types of safety or efficacy issues" and "do not adversely impact device performance." Specific numerical acceptance values or detailed performance data are not provided in this 510(k) summary (which is typical for such summaries, as detailed data is usually in the full submission).
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated for each test (e.g., how many devices were tested for static compression). The tests appear to be benchtop mechanical engineering tests, not tests on biological samples or patient data.
- Data provenance: Not applicable in the context of clinical data. These are laboratory-based mechanical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device's evaluation is based on engineering performance tests against established ASTM standards and an industry-accepted methodology for expulsion testing. It does not involve human expert interpretation of data points in the way a diagnostic AI would.
4. Adjudication method for the test set
- Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for mechanical performance testing against objective 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
- No such study was done. This document is for an interbody fusion device, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to diagnostic AI system performance; the device is a physical implant.
7. The type of ground truth used
- Objective engineering standards and measurements: The "ground truth" for the performance testing is adherence to the specified ASTM standards and an "industry accepted methodology" for expulsion testing. This is based on physical properties and mechanical behavior.
8. The sample size for the training set
- Not applicable. This evaluation does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. This evaluation does not involve machine learning or 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.