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pezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The pezo™ PEEK Cage Family is comprised of three principal interbody fusion cages. The pezo-P and pezo-T devices have a basic rectangular shape while the pezo-A devices have a basic kidney shape. All implants have a hollow center for placement of autograft. The pezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The information provided describes a medical device called the "pezo™ PEEK Cage Family," an intervertebral body fusion device. The submission outlines its technological characteristics and performance data in comparison to predicate devices, rather than a study involving human subjects or AI. Therefore, many of the requested elements for AI/human reader studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Intended Use
• Basic Design (hollow for autograft)
• Material (polymer)
• Sizes (comparable dimensions)
• Fundamental scientific technology | pezo™ possesses the same technological characteristics as one or more of the predicate devices including intended use, basic design, material (polymer), sizes, and the same fundamental scientific technology. |
  | Mechanical Performance equivalent to or better than predicate devices:
• Static and dynamic compression
• Subsidence | Mechanical test results demonstrate that pezo™ performs as well as or better than the predicate devices according to ASTM F2077 (static dynamic compression) and ASTM F2267 (subsidence). This indicates the device is as safe and effective as the predicates. |

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

• Sample Size: Not applicable. This study involves mechanical testing of the device, not a test set of data like in AI studies. The "worst case pezo™ device" was used, implying a single representative sample or a small number of samples, but specific numbers are not provided.
• Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the device itself.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077, ASTM F2267) and direct measurement, not expert consensus in the human assessment sense.
• Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing the mechanical tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subject to adjudication by multiple human reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done: No. This submission does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done: No. This device is a physical intervertebral fusion cage, not an algorithm or AI system. Its performance is evaluated through mechanical testing, not a standalone algorithm study.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for device performance is based on established industry standards and objective material properties/mechanical strength measurements. Specifically, the device was tested according to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence). The performance of predicate devices against these same standards would form the basis for comparison.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, there is no corresponding ground truth to be established in that context.

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