(105 days)
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added Scarlet® AC-T implant is a cervical Intervertebral Body Fusion device with integrated Fixation. It consists of an interbody cage intended to be used with the two bone screws provided as a stand-alone system and requires no additional supplementary fixation system. Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added Scarlet® AC-T implant is a box-shaped spacer with a central cavity that can be filled with bone graft (autograft) to facilitate fusion and with two cancellous bone screws that pass through screw holes within its body. The added Scarlet® AC-T intervertebral body fusion spacer comes in various sizes in order to accommodate different patient anatomies.
The provided document is a 510(k) Premarket Notification for a medical device (SCARLET® AC-T intervertebral body fusion device). This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include detailed studies with acceptance criteria and device performance as one would find for an AI/ML device.
The document discusses non-clinical testing for the SCARLET® AC-T, which are mechanical tests to demonstrate structural integrity and comparability to predicate devices. It does not involve AI or algorithms, human readers, or ground truth in the sense of clinical diagnoses or outcomes.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth because this information is not relevant to the type of device and submission described in the input document. The document pertains to a physical implantable device, not a diagnostic or AI-driven system.
However, I can extract the information relevant to the non-clinical testing performed:
1. Table of acceptance criteria and the reported device performance:
| Test Method (Reference Standard) | Purpose | Reported Performance |
|---|---|---|
| Static and dynamic axial compression | To assess the device's ability to withstand compressive forces encountered in the spine. | Results demonstrate comparable mechanical properties to the predicate devices. |
| Static and dynamic shear compression | To assess the device's ability to withstand shear forces encountered in the spine. | Results demonstrate comparable mechanical properties to the predicate devices. |
| Static and dynamic torsion testing (ASTM F2077) | To assess the device's ability to withstand torsional forces encountered in the spine. | Results demonstrate comparable mechanical properties to the predicate devices. |
| Subsidence testing (ASTM F2267) | To assess the device's resistance to sinking into the adjacent bone. | Results demonstrate comparable mechanical properties to the predicate devices. |
| Expulsion testing (ASTM Draft F04-25.02.02) | To assess the device's resistance to being expelled from its intended position. | Results demonstrate comparable mechanical properties to the predicate devices. |
2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for these mechanical tests, but they are typically performed on a limited number of physical device units (e.g., 5-10 samples per test condition) in a laboratory setting. The "data provenance" would be laboratory testing results of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are mechanical engineering tests, not clinical evaluations requiring expert consensus or ground truth in a diagnostic sense.
4. Adjudication method 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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for mechanical testing is based on engineered specifications and comparison to predicate device performance under standardized test conditions.
8. The sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning device.
§ 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.