(436 days)
The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.
Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.
This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.
However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.
Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) of physical device) | Reported Device Performance (Summary from Document) |
|---|---|
| Material Equivalence: New materials (Vestakeep 4iR PEEK, Titanium Alloy) must have equivalent or superior mechanical properties to previously cleared materials (Zeniva ZA-500 PEEK). | • Vestakeep 4iR PEEK is "equivalent in mechanical properties" to Zeniva ZA-500. |
| • Titanium alloy devices are "substantially stronger than those made from PEEK." | |
| Size/Geometric Equivalence: New implant sizes must not represent a new "worst-case" scenario compared to the previously tested worst-case size. | • All additional sizes are "larger in bearing footprint than the worst-case size tested for K113478." |
| • The "worst-case size testing submitted as part of K113478 applies to all devices that are part of this current submission." | |
| Biocompatibility: Materials must meet established medical grade standards. | • PEEK (ASTM F2026) with Tantalum (ASTM F560) |
| • Titanium alloy (ASTM F136) | |
| Mechanical Strength: Device must withstand intended loads. | • "Additional testing (compression) per ASTM F2077 verified that the addition of new materials did not introduce a new worst-case." |
| Radiographic Visualization: For PEEK devices, radiographic markers must be present. | • Tantalum pins are embedded in PEEK versions for radiographic visualization. |
2. Sample sized used for the test set and the data provenance:
- The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
- Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.
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 for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is for a physical interbody fusion cage.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
§ 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.