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The Incite Anchored Cervical Interbody Device 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. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

The Incite Anchored Cervical Interbody (ACI) Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Device is manufactured from PEEK and Ti 6A1 4V titanium alloy with tantalum radiopaque markers.

Purpose of this 510(k) submission: The purpose of this submission is to add the updated ACI II Inserter to the ACI System. The ACI II Inserter is used with the Incite Innovation Anchored Cervical Interbody Device. The inserter places the implant in the surgical site, deploys the anchor and detaches from the implant. The patient contacting material of the inserter is stainless steel (SS 17-4). The ACI II Inserter has been modified to be smaller, lighter in weight and easier to use.

The provided text describes a 510(k) premarket notification for the Incite Anchored Cervical Interbody Device, specifically focusing on an updated inserter (ACI II Inserter). It does not contain information about acceptance criteria or a dedicated study proving the device meets distinct performance criteria and does not describe AI/ML aspects of a medical device.

Key points from the document regarding "performance data":

• Device Under Review: The primary focus of this 510(k) submission (K150913) is to add an "updated ACI II Inserter to the ACI System." The Incite Anchored Cervical Interbody Device itself (the implant) has not changed since previous submissions (K130306 and K122008).
• Performance Data Provided: The section "VII. PERFORMANCE DATA" specifically addresses the ACI II Inserter.
  • Design Verification: Involved "verification of the ACI II Inserter component dimensions performed through Device Interface Analysis (DIA)." This analysis aimed to ensure "that the interfacing components fit and function as specified for the components of the instrument as well as, the instrument with the implant."
  • Design Validation: "Based on products requirements for the ACI II Inserter and on the previous inserter user validation methodology (ACI Inserter, K122008 & K130306)." This validation used a "human cadaver demonstrated that the instrument met the user's needs in terms of overall use by attaching, placing, deploying and detaching from the implant."
• Conclusion: "Verification and validation data demonstrate that the performance and functionality of the ACI II Inserter is substantially equivalent to the ACI Inserter."

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, or AI/ML-related performance metrics because this information is not present. The document focuses on demonstrating substantial equivalence of a modified surgical instrument, not a new implant or an AI/ML-driven device.

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The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative 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. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers

The provided text describes a Special 510(k) Summary for a medical device called the "Incite Anchored Cervical Interbody Fusion (ACI) Device." This type of submission focuses on demonstrating substantial equivalence to a predicate device, often for minor modifications rather than entirely new devices requiring extensive clinical trials for efficacy.

Based on the provided document, here's a breakdown of the acceptance criteria and the study used:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states that "additional mechanical testing on the new size is not warranted." This means there was no new physical test set specifically for the 16x14mm device being cleared in this 510(k). The "test set" for the performance criteria refers to the testing data from the predicate device (K122008). The document does not specify the sample size (e.g., number of devices tested for static compression, torsion, etc.) used for the predicate device's original testing.
• Data Provenance: The data provenance is retrospective, as it relies entirely on the performance testing previously conducted and accepted for the predicate device (K122008). The country of origin of the data is not specified, but it would have been generated as part of the predicate device's original regulatory submission.

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

• This information is not applicable and not provided in the document. The study is a mechanical performance comparison based on engineering principles and previous device testing, not a clinical or diagnostic study involving human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As above, this is a mechanical performance study, not a study requiring adjudication of expert opinions.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess the impact on human reader performance. This submission is for an implantable medical device, and the demonstration of substantial equivalence relies on mechanical performance data and comparison of physical attributes.

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

• No, a standalone performance study was not done. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance aspects is based on engineering and biomechanical testing standards and the results obtained from the predicate device's testing against those standards. It is not expert consensus, pathology, or outcomes data. The ground for "substantial equivalence" is the direct comparison of design, materials, and intended use to the predicate device, along with the reasoning that the new size does not introduce a "new worst case condition."

8. The Sample Size for the Training Set

• This information is not applicable and not provided. There is no "training set" in the context of this device and its regulatory submission, as it is not an AI/ML algorithm.

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

• This information is not applicable and not provided. As there is no training set, there is no ground truth to establish for it.

In summary:

The study presented here is a Special 510(k) submission based on substantial equivalence to a predicate device (K122008). The "study" for acceptance criteria is primarily a justification based on engineering principles and previously accepted mechanical test data from the predicate device. The key argument is that the dimensional differences of the new device (a larger footprint 16x14mm) do not create a "new worst-case condition" compared to the predicate device, thus making the predicate's performance data applicable to the new size. No new testing was performed for this specific submission for the new size.

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