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The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 implant with three Tantalum marker pins. The spacers are offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implants have serrations on the top and bottom surfaces of the spacer. The hollow space of the implant is intended to hold bone graft material. The IBD PEEKC spacer is to be used as an interbody fusion device (IBD) for the cervical spine (from C2-C3 to C7-T1).

The Ascential IBD PEEKC Spacers to be used for cervical IBD applications are available in a variety of sizes, from 4 mm to 12 mm in height (in 1 mm increments), two depths: 12 mm and 14 mm and two widths: 14 mm and 16 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to choose the size better suited to the patient's anatomy and pathology.

Class I instruments are provided for successfully performing anterior cervical interbody fusion procedures.

The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of the AVS® AS PEEK Spacer

The provided text is a 510(k) Premarket Notification for the Ascential IBD PEEK(c) Spacer, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to a predicate device, the AVS® AS PEEK Spacer (K142251), particularly regarding the impact of terminal sterilization (gamma sterilization) on the device's material properties and performance.

The "study" or justification provided in this document is a comparison of material properties after sterilization and reliance on previous testing of the predicate device. It is not a clinical study or a comparative effectiveness study involving human readers or AI.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance (Table)

This document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes that would typically be associated with AI or diagnostic device studies. Instead, the acceptance criteria are implicitly related to maintaining the mechanical properties and sterility of the device after gamma sterilization, and being "substantially equivalent" to an existing predicate device.

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

• This document describes engineering and material testing, not a clinical study with a "test set" of patient data in the context of AI or diagnostic devices.
• The "test set" for material properties would be samples of the PEEK-OPTIMA® material that underwent gamma sterilization and subsequent mechanical testing. The specific number of samples for these tests is not mentioned in the provided text.
• Data provenance: The "supporting documentation from Invibio" refers to the PEEK material manufacturer. The location of this testing is not specified, nor whether it was retrospective or prospective in relation to this specific device submission.

2. 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)

• This question is not applicable to the type of data presented in this submission. There is no "ground truth" established by human experts in the context of image interpretation or clinical diagnosis. The "ground truth" here is the result of laboratory mechanical and sterility testing.

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

• This question is not applicable. No adjudication method for expert review of a test set is mentioned.

4. 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 MRMC comparative effectiveness study was done. This document is for a physical intervertebral body fusion device, not an AI or diagnostic imaging device.

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

• Not applicable, as this is not an AI algorithm.

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

• The "ground truth" for this submission revolves around:
  • Mechanical properties: Measured directly through laboratory testing (e.g., tensile strength, compressive strength, flexural modulus, etc. - though specific tests are not detailed beyond "mechanical performance").
  • Sterility: Demonstrated through bacterial endotoxin testing (BET) and sterility assurance level (SAL) studies (implied by "sterilization process and sterile barrier packaging system are effective").
  • Substantial Equivalence: Based on comparison of design, materials, technological characteristics, and intended use to a legally marketed predicate device, supported by the material property testing.

7. The sample size for the training set

• Not applicable, as this is not an AI algorithm requiring a training set.

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

• Not applicable.

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