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The Elaris Pedicle Screw System is intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.

The ELARIS Pedicle Screw System consists of the following components: Elaris Pedicle Screws, Elaris Pins, Elaris Rod, Elaris Set Screw, Dedicated Manual Instruments, and an Ultrasonic System, which includes the ultrasonic generator (BoneWelder 150-W1) with corresponding footswitch and power cord, and the spring loaded Elaris Handpiece with the Elaris Connector, which rigidly couples the housing of the Elaris Handpiece with the Elaris Pedicle Screw. The cannulated pedicle screws are available in two diameters and four lengths and contain a distal fenestration to optionally allow injection of resorbable polymer into the cancellous bone of the vertebral body. The Ti alloy screws are multiaxial, and are rigidly attached to the set screw. The Elaris Pin can intraoperatively be inserted into the screws cannulation. The Elaris handpiece can be connected to the pedicle screw head, and using the BoneWelder, the polymer is ultrasonically heated so that it melts and is extruded out of the fenestrations.

The provided text is a 510(k) summary for the Elaris Pedicle Screw System. It describes the device, its intended use, and comparative data against a predicate device to demonstrate substantial equivalence. However, it does not explicitly state acceptance criteria in a structured manner or detail a specific study proving the device meets those criteria with the requested information (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth types, training set size and ground truth establishment).

The document focuses on demonstrating substantial equivalence to a predicate device (Medtronic's CD Horizon Pedicle Screw System) through various mechanical and material tests. It also mentions an animal study for bioresponse.

Here's an attempt to extract and infer the information based on the provided text, acknowledging that many details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table with quantified targets. Instead, the document argues for "substantially equivalent" performance to the predicate device. The performance data presented demonstrates that the device performs at least as well as or better than the predicate in certain aspects or is characterized without adverse findings.

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

The document mentions various tests but does not specify the sample size (N) for each test set nor the data provenance in terms of country of origin or whether the studies were retrospective or prospective.

• Mechanical Tests (ASTM F1717, pullout, toggle): Standardized tests typically involve a specific number of samples, but the exact count is not given.
• Animal Study: "Spine fusion animal study" is mentioned, but the number of animals used or other details are not provided.
• Polymer Characterization, Temperature Distribution, Screw Removal, Cavitation, Swelling, Flow Analysis, FEA: These are bench/material/simulation tests. Sample sizes are not stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This section is not applicable as the document describes a medical device (pedicle screw system), not an AI/software device that requires expert-established ground truth for performance evaluation in the described context. The performance evaluation is based on mechanical properties, material science, and animal studies.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. Adjudication methods are typically used when human interpretation of data (e.g., medical images) is involved in establishing a ground truth for an AI algorithm.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is a hardware implant (pedicle screw system), not an AI-assisted diagnostic or treatment planning tool for which MRMC studies are conducted to assess human performance with and without AI.

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

This section is not applicable for the same reasons as #5. The device is a physical implant.

7. The Type of Ground Truth Used

For the various tests performed, the "ground truth" implicitly refers to:

• Mechanical Tests: Established engineering standards (e.g., ASTM F1717), material properties, and comparison to the predicate device's known performance.
• Polymer Characterization: Material science principles, chemical analysis, and degradation studies to understand the polymer's behavior and composition before/after melting and over time.
• Animal Study: Histological analysis, radiological assessment, and clinical observation in the animal model to evaluate bioresponse and fusion outcomes. These outcomes would serve as the "ground truth" for biocompatibility and efficacy in that model.

8. The Sample Size for the Training Set

This section is not applicable as the description is for a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reasons as #8.

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