(307 days)
The Tailored-C Cervical Interbody Fusion Devices 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. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Tailored-C Cervical Interbody Fusion System is an intervertebral spinal fixation system comprised of additively manufactured cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to optimize patient fit. The footprints are offered at 11x13mm, 12x14mm, 14x16mm, 16x18mm, and 17x19mm. The lordosis is offered at 0°, 4°, and 7°. The height ranges from 5mm to 12mm in 1mm increments. All implant components are manufactured from Ti-6A1-4V per ASTM F3001.
This FDA 510(k) summary describes a physical medical device (an intervertebral fusion system), not a software or AI-based device. Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not applicable.
The document discusses the mechanical performance testing of the Tailored-C Cervical Interbody Fusion System. Here's a breakdown of the relevant performance data and conclusion provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table format with corresponding reported values. Instead, it lists the types of performance tests conducted and generally states that the results show the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
| Test Mode (per ASTM standard) | General Reported Performance |
|---|---|
| Static Axial Compression (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Static Compression Shear (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Static Torsion (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Subsidence (F2267) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Dynamic Axial Compression (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Dynamic Compression Shear (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
| Dynamic Torsion (F2077) | Strength is sufficient for intended use and substantially equivalent to predicate devices. |
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. This is a mechanical device, and testing involves physical samples of the device itself rather than data from human subjects. The testing standards are ASTM F2077 and F2267, which are international standards for intervertebral body fusion device testing.
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. Ground truth, in the context of AI/software, refers to verified labels or diagnoses. For a mechanical device, performance is measured against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is relevant for human interpretation or labeling tasks, not for mechanical testing.
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 interbody fusion system, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the AI/software sense. The "ground truth" for mechanical testing would be the established engineering specifications and performance requirements defined by standards like ASTM F2077 and F2267, against which the device's physical performance is measured.
8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided text details the mechanical testing performed on the Tailored-C Cervical Interbody Fusion System to demonstrate its substantial equivalence to predicate devices, focusing on its physical strength and durability according to established ASTM standards. The concepts of AI/software performance evaluation requested in the prompt do not apply to this type of medical device 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.