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Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated for the following: Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondylolisthesis Spinal Stenosis Fracture/dislocation Atlantoaxial fracture with instability Occipitocervical dislocation Revision of pervious cervical spine surgery Tumor When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 – T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System and/or the Synthes Axon System. The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.

The provided 510(k) summary for the Synthes Synapse System focuses on demonstrating substantial equivalence to predicate devices through design modifications, material commonality, and intended use. The performance data section explicitly states that "Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, the information required to populate most of the acceptance criteria and study design details (especially those related to clinical studies, ground truth, expert review, training data, etc.) is not available in the provided document. The submission relies solely on non-clinical bench testing to demonstrate substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

Acceptance Criteria and Device Performance Study for the Synthes Synapse System (K070573)

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical data was not required and no specific objective acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, or mechanical properties) are detailed as "acceptance criteria" in a quantitative sense, this table will reflect the qualitative overarching acceptance criterion of "substantial equivalence" as demonstrated by bench testing.

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

• Test Set Sample Size: Not specified in terms of number of devices, materials, or specific test configurations. The document only references "bench testing results."
• Data Provenance: Not applicable in the context of clinical data. It refers to non-clinical laboratory bench testing. The country of origin for the testing itself is not stated.
• Retrospective/Prospective: Not applicable, as this refers to a non-clinical bench study, not a human subjects study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth in the context of expert review or clinical diagnosis was established as this was a non-clinical bench study.

4. Adjudication method for the test set

• Not applicable. No human experts or clinical cases were adjudicated.

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

• No. An MRMC study was not conducted. This device is a surgical 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 device is a surgical implant, not an algorithm.

7. The type of ground truth used

• Not applicable. For a non-clinical bench test, the "ground truth" would be established by validated scientific methodologies, engineering specifications, and measurement standards for mechanical properties (e.g., fatigue strength, torsional rigidity, pull-out strength). The document does not specify these individual "ground truths" but concludes overall substantial equivalence.

8. The sample size for the training set

• Not applicable. This involved non-clinical bench testing of a medical device, not a machine learning algorithm requiring a training set.

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

• Not applicable. See point 8.

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