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The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The acceptance criterion for the mechanical tests was set as follows:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. This document describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Pertains to human review of data, not mechanical testing.

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:

• No. This was not an MRMC study and did not involve human readers or AI assistance.

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

• No. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for this device's performance is objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device.

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

• Not Applicable. This is not an AI or machine learning device.

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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 Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.

The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.

These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.

Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.

The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).

The provided text describes a medical device, the "Unison®-C Anterior Cervical Fixation System," and its clearance by the FDA. However, it does not detail a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance (mechanical testing) rather than clinical studies or performance against specific AI/ML criteria. Therefore, most of the requested information regarding AI/ML device performance and ground truth establishment cannot be extracted from this document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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