(130 days)
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.
The Incite Anchored Cervical Interbody Fusion Device is a medical device designed to act as a spacer in the cervical spine to maintain proper intervertebral and vertebral body spacing and angulation. The provided text describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain details about a clinical study with acceptance criteria and reported device performance in the way a typical AI/software device would.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through bench testing (performance testing) and comparison of design, materials, and function.
Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:
Most of the requested information (points 2-9) pertains to clinical studies involving human patients or detailed software validation, which are not described in this 510(k) summary for this type of medical implant.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from recognized standards for spinal implants) | Reported Device Performance (from testing) |
|---|---|
| Axial Compression - Static (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Axial Compression - Dynamic (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Compression-Shear - Static (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Compression-Shear - Dynamic (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Torsion - Static (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Torsion - Dynamic (per ASTM F2077) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Subsidence (per ASTM 2267) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Expulsion (per ASTM Draft F04.25.0202) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. |
| Cadaver Lab (No specific standard mentioned, likely for surgical technique/fit) | Demonstrated substantial equivalence to predicate devices and suitability for intended use. (Details of findings not provided, only that it was performed). |
| Substantial Equivalence (General) | "The Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices when considering indications for use, design, materials, and function." |
Note on "Acceptance Criteria" for this device: The acceptance criteria are essentially defined by the recognized ASTM standards listed for each test. The actual numerical thresholds (e.g., minimum load to failure, maximum displacement) are not provided in this summary, but the device is stated to have met the performance requirements implied by these standards and shown substantial equivalence to predicate devices.
Regarding the study that proves the device meets the acceptance criteria:
The "study" in this context refers to the Performance Testing section described. It's a series of bench tests (mechanical and physical tests performed in a lab setting) and a Cadaver Lab, rather than a clinical trial with human subjects for direct outcome measurement.
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not specified for each individual test. For mechanical tests, this typically involves a certain number of devices tested to failure or under specific load conditions. For the Cadaver Lab, the number of cadavers is not mentioned.
- Data Provenance: The tests are performed in a lab setting (likely by the manufacturer or a contract testing facility) to comply with recognized ASTM standards. This is laboratory-generated data, not human patient data in the context of a "test set" for performance evaluation in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of device and testing. Ground truth for mechanical performance is established by objective physical measurements against engineering specifications and standard requirements, not through expert consensus on interpretation. For the Cadaver Lab, surgical experts might have evaluated surgical technique or fit, but details are not provided.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical trials or image interpretation studies where human experts are making judgments. For mechanical testing, the results are quantitative and directly measured.
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 spinal implant, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant device, not an algorithm.
7. The type of ground truth used
The ground truth for this device's performance is established by:
- Compliance with recognized ASTM standards (e.g., F2077, F2267). These standards define acceptable mechanical properties and performance characteristics for intervertebral body fusion devices.
- Substantial equivalence to already legally marketed predicate devices, meaning its performance, design, and materials are comparable and safe for the intended use.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI. Performance is evaluated against engineering standards and comparison to predicates.
9. How the ground truth for the training set was established
Not applicable. As there's no "training set," there's no ground truth to establish for it in this context.
§ 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.