(20 days)
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.
The provided 510(k) summary for the Eisertech, LLC Cervical Cage does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've described for an AI/ML device.
This 510(k) is for a medical device (an orthopedic implant), not an AI/ML diagnostic or therapeutic device. The submission is a Special 510(k), which focuses on a minor change to an already cleared device, specifically changing the material of the marker pins from titanium to tantalum.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of device and submission.
Here's a breakdown of why the requested information is absent and what is provided:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The submission states, "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." For this type of mechanical device, performance would typically relate to mechanical strength, biocompatibility, and radiographic visibility. The change to tantalum for marker pins aligns with existing material standards (ASTM F560) and is explicitly stated as not affecting overall performance. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) reported for this device in the context of diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There was no "test set" in the context of evaluating diagnostic performance or algorithm output. The submission relies on the substantial equivalence principle, where the modified device is compared to a previously cleared device and a predicate device with similar material usage.
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. No ground truth establishment by experts for a test set was performed, as this is a medical implant, not a diagnostic tool requiring expert interpretation for validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication was used.
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 a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As no performance study requiring ground truth was conducted for this specific submission, no ground truth types are mentioned. The substantial equivalence argument rests on material properties and device design.
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. No training set, no ground truth establishment for a training set.
Summary of Relevant Information from the Document:
- Purpose of Submission: To change the material of marker pins from titanium to tantalum.
- Device Description: Cervical Cage manufactured from PEEK with tantalum marker pins for radiographic visualization.
- Justification for No Additional Testing: "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." This is based on:
- Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
§ 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.