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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

The InFill® Interbody Fusion Device product family consists of radiolucent implantable devices manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Interbody Fusion Device is provided sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "InFill® Interbody Fusion Device." This submission aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and as such, it does not involve a study to prove the device meets acceptance criteria in the typical sense of a clinical trial or AI/software validation.

Instead, the "acceptance criteria" here are based on the device's technological characteristics and mechanical performance data meeting established industry standards (ASTM) and being comparable to legally marketed predicate devices.

Let's break down the information requested in your prompt based on the provided document:

1. Table of acceptance criteria and the reported device performance

There isn't a direct "acceptance criteria" table with numerical performance targets in the context of an AI/software validation study. Instead, the acceptance is based on the device meeting established ASTM standards and being substantially equivalent to predicates.

Note: The document explicitly states, "the minor differences do not raise any new issues of safety and effectiveness" and "The overall technology characteristics and mechanical performance data lead to the conclusion that the InFill® Interbody Fusion Device is substantially equivalent to the predicate device." This is the ultimate "acceptance" for a 510(k).

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

• Sample Size for Test Set: Not applicable in the context of a clinical study with patients. The "test set" here refers to the physical devices undergoing mechanical testing. The document states "The InFill® V2 Lateral Device (worst case device) has been tested..." This implies a sample size of physical devices tested to ASTM standards. The exact number of physical devices tested for each mechanical test is not specified in this summary, but these are typically small sample sizes for engineering verification (e.g., n=5 or n=10 devices per test).
• Data Provenance: The data comes from non-clinical mechanical testing performed on the physical device. The location of the testing is not specified but would typically be an accredited testing lab. This is a form of prospective testing of the manufactured devices, not retrospective clinical data.

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 mechanical device submission, not an AI or diagnostic imaging device requiring expert ground truth for interpretation of images or patient data. The "ground truth" for mechanical testing is established by the ASTM standards themselves and the objective measurements of the device's physical properties under various loads.

4. Adjudication method for the test set

• Not applicable. There is no human interpretation or adjudication involved in the mechanical testing of physical properties. The results are quantitative measurements against defined 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 device is an implantable interbody fusion device, not an AI or software-as-a-medical-device (SaMD) for diagnostic assistance. Therefore, no MRMC study or AI-assisted human reader performance was conducted or reported.

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

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

7. The type of ground truth used

• The "ground truth" for this submission is established by validated ASTM international standards for the mechanical testing of intervertebral body fusion devices (e.g., F2077, F2267). These standards define the acceptable range of mechanical performance for these types of implants. The comparison is also made against the mechanical performance of predicate devices already on the market.

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, there is no ground truth established for one.

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