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The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.

The provided 510(k) summary for the Eisertech, LLC Cervical Cage does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've described for an AI/ML device.

This 510(k) is for a medical device (an orthopedic implant), not an AI/ML diagnostic or therapeutic device. The submission is a Special 510(k), which focuses on a minor change to an already cleared device, specifically changing the material of the marker pins from titanium to tantalum.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of device and submission.

Here's a breakdown of why the requested information is absent and what is provided:

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

• Not Applicable. The submission states, "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." For this type of mechanical device, performance would typically relate to mechanical strength, biocompatibility, and radiographic visibility. The change to tantalum for marker pins aligns with existing material standards (ASTM F560) and is explicitly stated as not affecting overall performance. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) reported for this device in the context of diagnostic performance.

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

• Not Applicable. There was no "test set" in the context of evaluating diagnostic performance or algorithm output. The submission relies on the substantial equivalence principle, where the modified device is compared to a previously cleared device and a predicate device with similar material usage.

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. No ground truth establishment by experts for a test set was performed, as this is a medical implant, not a diagnostic tool requiring expert interpretation for validation.

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

• Not Applicable. No test set requiring adjudication was used.

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 implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm or software device.

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

• Not Applicable. As no performance study requiring ground truth was conducted for this specific submission, no ground truth types are mentioned. The substantial equivalence argument rests on material properties and device design.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. No training set, no ground truth establishment for a training set.

Summary of Relevant Information from the Document:

• Purpose of Submission: To change the material of marker pins from titanium to tantalum.
• Device Description: Cervical Cage manufactured from PEEK with tantalum marker pins for radiographic visualization.
• Justification for No Additional Testing: "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." This is based on:
  • The primary material (PEEK) and geometry are unchanged from the predicate K110915.
  • The new marker pin material (tantalum, ASTM F560) is identical to that used in another predicate device (Nexxt Spine Honour Spacer System, K120345).
• Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.

Cervical Cage Acceptance Criteria and Study Details

The provided document describes the Eisertech, LLC Cervical Cage, an intervertebral fusion device. The acceptance criteria and supporting study are focused on the device's mechanical performance and substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the mechanical testing of the Cervical Cage. The phrase "the Cervical Cage was tested" implies a singular or small number of devices were tested for each scenario.
• Data Provenance: The data is from prospective bench testing of the device prototypes, conducted by Eisertech, LLC. The "country of origin of the data" is not explicitly stated but can be inferred as the USA, where Eisertech, LLC is located.

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

• This information is not applicable to this type of device and study. The "ground truth" for the mechanical performance of an implant like the Cervical Cage is established through objective, standardized biomechanical testing against defined loads and established material properties, not through expert human interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints (e.g., radiology reads). For biomechanical testing, the results are typically quantitative and objective measurements.

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 relevant for diagnostic devices that involve human interpretation of medical images. The Cervical Cage is a surgical implant, and its evaluation focuses on its mechanical integrity and biocompatibility.

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

• Yes, the testing described is a standalone (algorithm only without human-in-the-loop performance). The "algorithm" in this context refers to the device itself and its inherent mechanical properties, which were tested objectively without human involvement in interpreting the results beyond reading the quantitative data.

7. The Type of Ground Truth Used:

• The ground truth used for this mechanical performance study is based on engineering design requirements and established biomechanical standards (ASTM F2077 and ASTM F2267). These standards define the parameters and methodologies for testing intervertebral body fusion devices, and the device's ability to "meet or exceed" these accepted engineering benchmarks serves as the "ground truth" for its mechanical fitness.

8. The Sample Size for the Training Set:

• This information is not applicable. The Cervical Cage is a physical medical device, not an AI or software algorithm that undergoes machine learning training. There is no concept of a "training set" in this context. The design of the device would have involved engineering principles and potentially iterative prototyping and testing, but not in the sense of a machine learning training set.

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

• This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and mechanical properties would be established through engineering calculations, material science, and the aforementioned ASTM standards.

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