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MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of either PEEK-OPTIMA LT1 (Invibio) or VESTAKEEP i-Grade (Evoniks) PEEK with titanium alloy and titanium alloy marker pins.

Based on the provided text, the document describes the substantial equivalence determination for a medical implant (intervertebral fusion cage system), not an AI/software medical device. Therefore, many of the requested criteria (like ground truth establishment, MRMC studies, training/test sets for AI, expert qualifications for reading, etc.) are not applicable to this type of medical device submission.

The "study" referenced in the document is a mechanical performance testing of the implant, not a clinical study involving human patients or a study of an AI algorithm's performance.

Here's an analysis based on the information provided in the document:

The device in question is the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™. This is a physical implant used in cervical spinal fusion surgery.

1. Table of Acceptance Criteria and Reported Device Performance

Device Type: Intervertebral Body Fusion Device (Physical Implant)

Note: The document explicitly states that the new device's material composition (specifically the titanium alloy marker pins) is the main difference from the predicate. The performance testing was to demonstrate that this material change does not negatively impact the mechanical integrity and safety of the device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify an exact numerical sample size for the mechanical tests (e.g., number of devices tested). This testing typically involves a set number of physical units, but the specific quantity is not disclosed in this summary.
• Data Provenance: The tests are implied to have been conducted in a laboratory setting as part of the device manufacturing and validation process for regulatory submission. There is no indication of clinical data from patients or data related to country of origin in the context of mechanical testing. This is retrospective in the sense that the testing was performed on manufactured devices for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. For a mechanical implant, "ground truth" is established by adherence to engineering specifications and performance standards (like ASTM standards) through physical testing, not by expert interpretation of data like in AI or clinical studies. The results are objective, measurable physical properties.

4. Adjudication Method for the Test Set

• Not Applicable. This is a mechanical performance test, not a subjective interpretation requiring adjudication among experts. The results are quantitative and pass/fail against established engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is specifically relevant for diagnostic devices, particularly those involving human interpretation of imaging, and often for AI-assisted diagnostic tools. It is not relevant for a physical implant like an intervertebral fusion cage.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering/Performance Standards. The "ground truth" for this device's safety and effectiveness is its ability to meet established mechanical performance specifications (e.g., static and dynamic axial compression, subsidence) as defined by ASTM standards and comparison to its predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set.

Summary of the "Study" Proving Acceptance:

The "study" in this context refers to pre-clinical bench testing (mechanical performance testing) of the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™. The purpose of this testing was to demonstrate that the device is substantially equivalent to its predicate devices (K121569 and K162682) despite minor material differences (specifically, the use of titanium alloy marker pins within the PEEK material).

The performance data section clearly states: "The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria established previously for the predicate devices and demonstrate that the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ does not raise concerns regarding safety and effectiveness."

This means the acceptance criteria were based on the performance of the legally marketed predicate devices, and the new device successfully replicated or exceeded that performance in the specific mechanical tests deemed relevant by the FDA for this device type.

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MATISSE Anterior Cervical Interbody Fusion Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The MATISSE Anterior Cervical Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The MATISSE Anterior Cervical Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation systems that have been cleared for use in the cervical spine. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of either PEEK-OPTIMA LT1 or Evonik VESTAKEEP i4R, with Tantalum marker pins, or titanium alloy.

The provided text describes a medical device, the MATISSE Anterior Cervical Interbody Fusion Cage System, and its clearance under a 510(k) premarket notification. This type of clearance focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria related to typical AI/software performance metrics (e.g., sensitivity, specificity, accuracy).

Therefore, many of the requested details, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts used to establish ground truth," and "ground truth for training set," are not applicable to this document. This document describes a physical medical implant, not an AI or software-based diagnostic or assistive device.

However, I can extract information related to the performance data presented within the context of a physical device's mechanical and functional equivalence.

Here's a breakdown of the available information based on the provided text:

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

The document does not provide a table with specific numerical acceptance criteria (e.g., minimum load bearing, maximum displacement) nor the explicit numerical results for the device's performance against those criteria. Instead, it makes a general statement:

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

• Sample Size: The document does not specify the number of devices or iterations used for each test (e.g., how many cages were tested for axial compression). It refers to "the MATISSE Anterior Cervical Interbody Fusion Cage System device" undergoing tests, implying multiple units would have been used for mechanical testing, but no specific number is given.
• Data Provenance: Not applicable. These are lab-based physical performance tests of a device, not data collected from patients.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/software for diagnostic purposes is not relevant here. The "ground truth" for these tests would be the established engineering standards (ASTM F2077, ASTM F2267) and the physical measurements themselves.

4. Adjudication method for the test set

• Not Applicable. As these are physical performance tests against engineering standards, an adjudication method for human interpretation of data is not relevant. The results are quantitative measurements against predefined engineering standards.

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 a physical medical device (interbody fusion cage), not an AI-assisted diagnostic tool. No human reader study was performed or required.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" here refers to established engineering standards (ASTM F2077, ASTM F2267) and the physical properties and performance requirements for similar medical devices. The comparison is made against the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI model. There is no concept of a "training set" in this context.

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

• Not Applicable. As per point 8, there is no training set for this device.

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Matisse Anterior Cervical Interbody Fusion Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

Matisse Anterior Cervical Interbody Fusion Cage system intended for use as an . interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA®LTlwith marker pins made of Tantalum (ASTMF 560).

The provided document is a 510(k) summary for the Matisse Anterior Cervical Interbody Fusion Cage system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format of a clinical trial for a novel AI or diagnostic device.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission.

The "study" in this context refers to non-clinical (mechanical) testing used to demonstrate the device's physical properties are equivalent to devices already on the market.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic AI. Instead, it demonstrates performance by showing the device meets established ASTM standards for interbody fusion cages.

• ASTM F 2077: Specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing.
• ASTM F 2267: Specifically, Static Subsidence testing under Axial Compression.
  The document asserts that "the non-clinical testing conducted on the Lexus predicate [is] applicable to represent the Matisse Anterior Cervical Interbody Fusion Cage system." |
  | Design, materials, and intended use are identical or similar to legally marketed predicate devices. | The Matisse Anterior Cervical Interbody Fusion Cage system is stated to be "exactly identical" to the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and "substantially equivalent" to several other predicate devices regarding design, sizes, manufacturing process, materials (PEEK-OPTIMA® LTi with Tantalum marker pins), and intended use. |

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

• Sample Size: Not applicable in the context of an AI/diagnostic device's test set. For mechanical testing, this refers to the number of physical devices or components tested. The document does not specify the exact number of units tested for each ASTM standard, but implies a sufficient number were tested to satisfy the standards.
• Data Provenance: Not applicable for an AI/diagnostic device's data provenance. The testing was conducted for the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and considered applicable to the Matisse system due to their identical nature. The location of the testing laboratories is not specified.

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

Not applicable. This device is a physical implant, not an AI or diagnostic device requiring expert interpretation of outputs or ground truth establishment in this manner.

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

Not applicable. This is relevant for studies involving human interpretation or labeling, which is not the case for mechanical testing of an implantable device.

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 describes an MRMC study for AI/diagnostic devices, which is irrelevant to a spinal implant's 510(k) submission based on substantial equivalence and mechanical testing.

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

Not applicable. This concept applies to AI algorithms, not physical medical devices like the Matisse Anterior Cervical Interbody Fusion Cage system.

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

The "ground truth" for this device's performance is compliance with established ASTM mechanical testing standards (F 2077 and F 2267), which define acceptable physical and mechanical properties for intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. This pertains to AI/machine learning models, not physical devices.

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

Not applicable. As above, this is for AI/ML models.

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