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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 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.

The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous 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. The Scarlet® AC-T fixation screws are available with diameters 3.0 mm and 3.5 mm and come in various sizes so as to accommodate different patient anatomies. The SCARLET® AC-T spacer and screws are 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 describes a 510(k) submission for the SCARLET® AC-T Secured Anterior Cervical Cage, specifically a "SPECIAL 510k DEVICE MODIFICATION" related to an "Extension of the range of SCARLET® AC-T screws."

This document is a regulatory filing for a medical device and not a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm's performance. The information requested (acceptance criteria, study details, sample size, ground truth, expert qualifications, etc.) is typically found in performance studies for diagnostic or prognostic devices, especially those utilizing AI/ML.

The SCARLET® AC-T device is an intervertebral body fusion device made of titanium alloy, and the modification involves adding new screw sizes with a modified distal tip. The regulatory submission states that "No additional testing has been performed for the added Scarlet® AC-T fixation screws. A risk analysis was performed to determine that additional testing was not needed."

Therefore, I cannot provide the requested information because:

• There are no acceptance criteria or reported device performance for an AI/ML algorithm. This document is for a physical orthopedic implant.
• No study, as understood in the context of evaluating an AI/ML algorithm, was performed for this specific modification. The submission explicitly states no additional testing was done.
• There is no "test set," "ground truth," or "experts" involved in determining the performance of a software or AI component. The evaluation here is based on substantial equivalence to existing predicate devices, considering material properties, design features, and a risk analysis.

In summary, the provided text does not contain the information needed to answer the prompt as it pertains to the performance evaluation of an AI or software device.

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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:

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.

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