(510 days)
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick. The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).
This document is a 510(k) summary for a medical device called the "Curiteva Porous PEEK Cervical Interbody Fusion System." This type of document is used to demonstrate substantial equivalence to previously cleared devices rather than providing a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates the device's functional and safety equivalence through non-clinical performance data.
Therefore, many of the requested elements pertaining to clinical study design, ground truth, expert adjudication, and AI performance metrics are not applicable to this type of regulatory submission. I will address the relevant sections based on the provided text.
Here's a breakdown of the requested information based on the provided 510(k) Summary:
Acceptance Criteria and Device Performance Study
The "Curiteva Porous PEEK Cervical Interbody Fusion System" is a medical implant, and its regulatory clearance process (510(k)) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance acceptance criteria related to AI/ML or diagnostic accuracy, which would typically involve clinical studies with human readers and ground truth.
For this device, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates when subjected to a battery of non-clinical (mechanical) tests. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of explicit quantitative "acceptance criteria" with a pass/fail threshold, as might be found for a diagnostic AI, is not detailed in this type of 510(k) summary for a spinal implant. Instead, the performance is demonstrated by showing the device withstands stresses comparable to predicate devices and industry standards. The reported device performance is that the device meets or is sufficient for its intended use and is substantially equivalent to the predicate devices. The specific numerical results of these tests are not included in the summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Axial compression strength | Sufficient for intended use, substantially equivalent to predicate devices. |
| - Compression-shear strength | Sufficient for intended use, substantially equivalent to predicate devices. |
| - Torsion strength | Sufficient for intended use, substantially equivalent to predicate devices. |
| - Subsidence resistance | Sufficient for intended use, substantially equivalent to predicate devices. |
| - Wear debris characteristics | Sufficient for intended use, substantially equivalent to predicate devices. |
| - (Additional tests like expulsion, impaction) | Sufficient for intended use, substantially equivalent to predicate devices. |
| Material Compatibility: - Biocompatibility (implied) | PEEK (ASTM F2026) with Titanium alloy markers (ASTM F136), HA coating. |
2. Sample size used for the test set and the data provenance
The "test set" in this context refers to the physical samples of the Curiteva Porous PEEK Cervical Interbody Fusion System that underwent mechanical testing. The specific number of samples tested for each mechanical test is not provided in the summary.
Data Provenance: The data comes from non-clinical (laboratory) testing conducted on the manufactured device models. There is no mention of country of origin of the data or whether it's retrospective/prospective, as these terms are generally applicable to clinical human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic performance studies. For an intervertebral body fusion device, mechanical properties are evaluated against engineering standards and comparison to predicate devices, not against expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus "ground truth" among multiple readers. For mechanical testing of an implant, the results are derived from physical measurements and engineering analyses, not from human interpretation requiring adjudication.
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
This question is not applicable. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. This submission pertains to a physical spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This refers to AI algorithm performance. The Curiteva Porous PEEK Cervical Interbody Fusion System is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the traditional sense of clinical "ground truth." For mechanical tests, the "ground truth" is defined by established engineering principles, ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877), and the performance characteristics of previously cleared predicate devices. The device's performance is compared against these engineering benchmarks and predicate device data.
8. The sample size for the training set
This question is not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical implant and does not involve AI/ML.
9. How the ground truth for the training set was established
This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.
§ 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.