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The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.

The Implanet S.A.'s Calypso System is a spinal fixation device. The provided text details the performance data for the device, focusing on its mechanical strength and biological compatibility to demonstrate substantial equivalence to predicate devices. It does not describe an AI medical device. Therefore, several of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as they pertain to AI/ML device studies.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size" in terms of number of devices tested for each mechanical test. It mentions "bench testing," implying a set of physical samples were tested.

• Data Provenance: The tests are bench tests performed by Implanet S.A. No country of origin for data or retrospective/prospective status is relevant for these types of mechanical and biological tests.

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

Not applicable. Ground truth for mechanical and biological testing is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus interpreting complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies) to resolve disagreements. Here, objective measurements against pre-defined standards are used.

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

No. This is a spinal fixation device, not an AI medical device, so an MRMC study is not relevant to its regulatory submission.

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

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is defined by established industry standards and specifications (e.g., ASTM F1798, ASTM F1717, ISO 10993, ISO 11137, ISO 17665). The measurements taken during bench testing are compared directly against these quantitative and qualitative criteria.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set.

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