(59 days)
TRYPTIK® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment.
The components added within this submission include lordotic and convex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK® devices are made of PEEK OPTIMA LT1 conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK® devices are designed for an anterior approach.
The provided document describes the TRYPTIK® Anterior Intersomatic Cervical Cage and its 510(k) summary. This document focuses on the mechanical performance testing of the device rather than directly reporting on an AI/ML-driven study or clinical performance with detailed acceptance criteria and reported device performance metrics like accuracy, sensitivity, or specificity.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device cannot be extracted from this document, as it pertains to a traditional medical device (intervertebral body fusion device) and not an AI/ML product.
The performance data summarized in the document for the TRYPTIK® Anterior Intersomatic Cervical Cage relates to mechanical testing to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI/ML algorithm.
Here's a breakdown of what can be extracted, addressing the closest relevant points, alongside explanations for what cannot be:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria Basis | Reported Device Performance |
|---|---|---|---|
| Material Conformance | PEEK OPTIMA LT1 | Conforming to ASTM F2026 | Device made of PEEK OPTIMA LT1 conforming ASTM F2026. |
| Marker Material | Titanium Markers | Conforming to ASTM F136 | Markers made of titanium conforming ASTM F136. |
| Mechanical Testing | Static and dynamic compression, shear, torsion | Overall Acceptance Criteria: Demonstrate that additional components perform as safely and effectively as their predicate devices (as per Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - June 12, 2007). Implicit: Meet or exceed performance of predicate devices in these tests. | "Results demonstrate that additional components perform as safely and effectively as their predicate devices." (Detailed numerical results are not provided in this summary.) |
| Subsidence Testing | According to ASTM F2267 | Overall Acceptance Criteria: Demonstrate performance as safely and effectively as predicate devices. Implicit: Meet or exceed performance of predicate devices. | Performed according to ASTM F2267. "Results demonstrate that additional components perform as safely and effectively as their predicate devices." |
Note: This table reflects the mechanical testing requirements for this physical implant device, not the performance metrics typically associated with AI/ML systems.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes mechanical performance testing of a physical implant (cervical cage), not an AI/ML device that would use a test set of data. The "tests" are mechanical evaluations of the device components.
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 / Not provided. The "ground truth" for this device's performance is established by standardized material and mechanical testing methods (ASTM standards) and comparison to predicate devices, not by expert consensus on clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for human interpretation tasks, often in clinical studies or expert review of outputs, which is not what this document addresses.
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. This is a physical medical device (cervical cage), not an AI/ML system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm; it is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Technical/Engineering Standards: The "ground truth" for this device's performance testing is adherence to established ASTM (American Society for Testing and Materials) standards for material properties and mechanical performance. The performance is then compared against legally marketed predicate devices to demonstrate substantial equivalence.
8. The sample size for the training set
- Not applicable / Not provided. This is a physical implant, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, there is no ground truth for a training set to be established.
In conclusion, the document (K122366) concerns the 510(k) clearance for a physical intervertebral body fusion device (TRYPTIK® Anterior Intersomatic Cervical Cage) based on mechanical testing and substantial equivalence to predicate devices, not an AI/ML diagnostic or prognostic tool. Therefore, most of the questions relating to AI/ML device evaluation criteria are not applicable to this specific submission.
§ 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.