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The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy

The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.

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

• Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
• Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.

4. Adjudication Method:

Not applicable.

5. MRMC Comparative Effectiveness Study:

Not applicable. No clinical studies involving human readers or AI assistance were performed.

6. Standalone Performance Study:

Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.

7. Type of Ground Truth Used:

Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.

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

Not applicable.

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