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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 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:

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.

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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 used at one 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

The SCARLET®AC-T Spinal System is a Cervical Intervertebral Body Fusion device with integrated fixation. It consists of an interbody cage intended to be used with the bone screws provided as a stand-alone system and requires no additional supplementary fixation system. SCARLET®AC-T is a box-shaped spacer with two cancellous bone screws that pass through screw holes within its body. It is intended to be used as a stand-alone interbody fusion device with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. SCARLET®AC-T intervertebral body fusion spacer comes in various sizes and footprints in order to accommodate different patient anatomies. It receives two cancellous bone screws that come in various diameters and lengths so as to better fulfill surgeon's needs and to accommodate anatomical variations.

The provided document is a 510(k) premarket notification for a medical device called the SCARLET® AC-T Secured Anterior Cervical Cage. This document describes the device, its intended use, and provides a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It does not present acceptance criteria or the results of a study designed to prove the device meets specific acceptance criteria in the way one might find for a diagnostic or AI-driven device.

Instead, the document focuses on demonstrating that the SCARLET® AC-T device is substantially equivalent to other legally marketed predicate devices, primarily through mechanical performance testing. The "acceptance criteria" here are implicitly tied to demonstrating comparable mechanical properties to these predicate devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission. This document is for a physical implantable device, not a diagnostic or AI-based system.

However, I can extract information related to the device and the mechanical tests performed:

1. Table of "Acceptance Criteria" (Implicitly, comparability to predicates) and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. These were non-clinical, in-vitro mechanical tests, not clinical studies with patient data. No "test set" in the sense of patient data was used. The document does not specify the number of devices or test repetitions for each mechanical test.
• Data Provenance: Not applicable. These are laboratory-based mechanical test results, not originating from a country or being retrospective/prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" established by experts for mechanical performance testing of a physical device in this context. The "truth" is determined by the physical properties and performance measured against engineering standards and a comparison to known predicate devices.

4. Adjudication method for the test set:

• Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.

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-driven or diagnostic device. No human reader studies or MRMC studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" (or reference for evaluation) is established by adherence to recognized ASTM and ISO standards for spinal implants and by comparing measured mechanical properties against those of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI-driven device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. There is no training set or ground truth in the context of machine learning.

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