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The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:

• Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors (primary and metastatic)
• Failed previous fusions
• Pseudoarthrosis
• Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

The Cervical Plate spinal internal fixation device made from titanium alloy (all components are made from ASTM F-136). It is provided in a variety of sizes ranging from 20mm to 110mm in length, and accommodating fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. All plates, regardless of length have a nominal thickness of 1.85mm and width of 18mm. Screws are provided in 4:0mm and 4.5mm diameters and in fixed and variable angle styles. Screws are prevented from backing out of the plate by attaching a separate locking mechanism. The mechanism is either a lock washer, consisting of a set screw attached to a washer, or a lock cover, which is a solid screw whose head captures both bone screws at the level of application.

The provided text describes a medical device, the "Cervical Plate," and its 510(k) summary for FDA clearance. However, it does not contain details about a clinical study that would typically involve acceptance criteria related to a device's performance in a human context, nor does it discuss ground truth established by experts, an MRMC study, or standalone algorithm performance.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to legally marketed predicate devices based on design and mechanical performance.
• Device Description: Material, sizes, and locking mechanisms.
• Indications for Use: The medical conditions for which the device is intended.
• Design Requirements: The need to stabilize the spine and maintain alignment.
• Risk Analysis Method: Qualitative summarization and quantitative analysis of in-vivo performance requirements, with test results meeting or exceeding design input.
• Performance Aspects: Testing according to ASTM F1717 for static axial compression, dynamic axial compression, and static torsion.
• Reliance on Standards: ASTM F1717 was used, but no specific performance standard exists for anterior cervical spinal plates.

Therefore, the requested information cannot be fully provided based on the input text. The "acceptance criteria" discussed are primarily mechanical performance benchmarks relative to design input and predicate devices, not clinical efficacy or diagnostic accuracy.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The testing was biomechanical/mechanical in a lab setting, not on patient data.
• Data Provenance: The tests were conducted according to ASTM F1717, which is a standard for in vitro mechanical testing of spinal implant constructs. This implies a controlled laboratory environment, not data from a specific country or retrospective/prospective patient data.

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

• Not applicable. Ground truth for a clinical or diagnostic study is not established in this context. The "truth" for this device's performance is its mechanical behavior under specified loads, measured in a lab.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There's no clinical "adjudication" in a mechanical performance study. The tests follow standardized protocols (ASTM F1717).

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 is a physical medical device (cervical plate), not an AI/software device that assists human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is based on the objective mechanical measurements obtained through standardized laboratory testing (ASTM F1717). This compares the device's physical properties (strength, stability) against engineering specifications and the performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is a physical device and not an AI/machine learning application.

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

• Not applicable.

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