(99 days)
The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2 serves to stabilize the spine while bony fusion develops.
The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations, heights and lordosis angles. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.
The anterior cover plate assembly attaches to the anterior most portion of the device. and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.
The provided text describes a 510(k) premarket notification for the SpineSmith IN:C2 Spinal Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through mechanical testing, rather than reporting on a clinical study or AI-driven performance. Therefore, many of the requested elements are not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance | Comments |
|---|---|---|
| ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices | Met (implied) | The non-clinical mechanical test results "demonstrate that any minor differences do not impact device performance as compared to the predicates." |
| ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression | Met (implied) | Same as above. |
| Draft Document Submitted to ASTM F-04.25.02.02: Static Pushout Test Method for Intervertebral Body Fusion Devices | Met (implied) | Same as above. |
| ASTM F1877-05: Standard Practice for Characterization of Particles | Met (implied) | Same as above. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission relies on mechanical (non-clinical) testing, not clinical data or a test set in the context of an AI model.
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 medical device clearance based on mechanical testing and substantial equivalence, not a study involving expert consensus for ground truth on patient data.
4. Adjudication method for the test set
Not applicable. No clinical test set.
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 submission concerns a physical medical device (spinal fixation system) and does not involve AI or human readers evaluating images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission does not involve an algorithm or AI.
7. The type of ground truth used
For the mechanical testing, the "ground truth" or acceptance criteria are the standards set by the relevant ASTM test methods (e.g., specific load resistance, deformation limits). The device's performance compared to these predefined engineering standards establishes its suitability.
8. The sample size for the training set
Not applicable. There is no AI model, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model, and therefore no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The SpineSmith IN:C2 Spinal Fixation System demonstrated its compliance with acceptance criteria through a series of non-clinical mechanical tests. These tests were conducted according to established ASTM (American Society for Testing and Materials) standards relevant to intervertebral body fusion devices. The specific standards cited are:
- ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices
- ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- Draft Document Submitted to ASTM F-04.25.02.02: Static Pushout Test Method for Intervertebral Body Fusion Devices
- ASTM F1877-05: Standard Practice for Characterization of Particles
The conclusion drawn from these tests was that "any minor differences [between the subject device and predicate devices] do not impact device performance as compared to the predicates." This indicates that the SpineSmith IN:C2 system performed comparably to, and met the safety and performance expectations set by, its predicate devices when subjected to these standardized mechanical stresses. The FDA's 510(k) clearance is based on this demonstration of substantial equivalence through mechanical testing, rather than clinical efficacy studies. The "acceptance criteria" were therefore the performance benchmarks inherent in these ASTM standards and the performance of the legally marketed predicate devices.
§ 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.