(24 days)
The Captiva Spine FuseLox Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Captiva Spine FuseLox implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The Captiva Spine FuseLox Cervical IBF System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
This is a 510(k) premarket notification for a medical device called the "Captiva Spine FuseLox Cervical IBF System." It is a premarket notification for a traditional medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML device performance, such as sample size, ground truth, expert adjudication, MRMC studies, and training set information, are not applicable.
The document states that the performance data indicates the subject device is substantially equivalent to predicate devices. This means that instead of conducting new clinical trials to evaluate specific performance criteria against a predefined acceptance threshold, the manufacturer demonstrated that their device performs similarly to devices that have already been cleared by the FDA.
Here's what can be extracted from the provided text based on the nature of this submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a traditional medical device (an intervertebral body fusion system), the "acceptance criteria" are primarily related to demonstrating equivalence to predicate devices, rather than specific performance metrics against a pre-defined numerical threshold for an AI/ML algorithm.
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K092794 Transcorp ACIF & K081730 Alphatec Novel Spinal Spacer System) | "The documentation provided demonstrates that the Captiva Spine FuseLox Cervical IBF System is substantially equivalent to the predicate devices." |
| Material Conformance | Implants manufactured from implant grade PEEK conforming to ASTM F2026-08. |
| Intended Use | Matches indications for use of predicate devices (skeletally mature patients with degenerative disc disease of the cervical spine at one disc level, C3-C7, anterior approach, autogenous bone graft, 6 weeks non-operative treatment, must be used with supplemental fixation). |
| Design Characteristics (shape, structure, features) | Implants are hollow to allow for autogenous bone graft. (Implied similarity to predicate designs through substantial equivalence claim). |
2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through substantial equivalence to predicate devices rather than a new clinical study with a test set of data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 traditional medical device, not an AI/ML-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the context of AI/ML performance evaluation is not relevant here. The "truth" for this submission is established by the accepted performance and safety profile of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.