(84 days)
SCARLET® AC-T cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. SCARLET® AC-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems.
When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
No design changes have been made to the Scarlet® AC-T cage. Same as the previously cleared devices (K141314, K141314), the Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with bone graft to facilitate fusion. Scarlet® AC-T is available in convex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heights in order to accommodate different patient anatomies. SCARLET® AC-T is made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device
The provided text is a 510(k) summary for the SCARLET® AC-T intervertebral body fusion device. It describes the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was demonstrated. However, this document does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in an AI/software as a medical device (SaMD) context.
Instead, the document details a mechanical testing study for a medical implant (an intervertebral body fusion device), not a software device. The "acceptance criteria" here relate to the mechanical performance standards for such an implant, and the "study" is a series of non-clinical mechanical tests.
Therefore, I cannot fulfill your request using the provided input in the context of an AI/SaMD device. The input describes a physical medical device.
However, I can extract the relevant information regarding the device's mechanical performance and how it meets its criteria, interpreting your request in the context of the provided document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (based on predicate device performance and standards) | Reported Device Performance (SCARLET® AC-T) |
|---|---|
| Meet or exceed performance of predicate devices for: | Meets or exceeds predicate device performance |
| - Static and dynamic axial compression (per ASTM F2077) | Pass |
| - Static and dynamic shear compression (per ASTM F2077) | Pass |
| - Static torsion (per ASTM F2077) | Pass |
| - Subsidence (per ASTM F2267) | Pass |
| - Expulsion (per internal protocol) | Pass |
| Bacterial endotoxin limit: 20 EU / device (per USP standard) | Meets endotoxin limit |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each mechanical test, but implied to be sufficient for demonstrating compliance with ASTM standards and predicate performance.
- Data Provenance: Not applicable in the traditional sense of patient data. The tests were non-clinical mechanical tests performed on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM) and comparison to predicate device performance, not human expert consensus on images.
4. Adjudication method for the test set:
- Not applicable. The "adjudication" is based on meeting the quantitative criteria specified by the ASTM standards and demonstrating equivalent or superior performance to predicate devices.
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 for a physical intervertebral fusion device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is for a physical intervertebral fusion device, not an AI software.
7. The type of ground truth used:
- Engineering Standards and Predicate Device Performance: The "ground truth" for the mechanical integrity and safety of the SCARLET® AC-T is based on its ability to meet or exceed established ASTM standards for intervertebral body fusion devices and to perform comparably to previously cleared predicate devices.
8. The sample size for the training set:
- Not applicable. This is for a physical medical device, not an AI software that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is for a physical medical device, not an AI software.
§ 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.