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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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The Osseus Black Diamond Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Osseus 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 of the components are available in a variety of sizes to match more closely the patient's anatomy.

This is a 510(k) summary for a spinal implant system and as such, it does not involve AI/ML device performance testing. The 'acceptance criteria' and 'device performance' in this context refer to mechanical and material performance rather than diagnostic accuracy or classification metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices." This implies that the device met the performance standards established by the predicate devices through these ASTM tests. The specific numerical acceptance criteria (e.g., maximum load, fatigue life) are not detailed in this summary document but would have been part of the full submission.

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

Given this is a mechanical engineering test of a physical device, not an AI/ML system:

• Sample Size for Test Set: The document does not specify the exact number of units or replicates tested for each static and dynamic test. These would typically be defined by the ASTM F1717 standard and the test protocol.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured devices, not on human patients or data derived from them. The data is generated from physical mechanical testing.

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

• This question is not applicable to this type of device submission. Ground truth, in the context of device performance described here, is established by adherence to ASTM standards for mechanical testing, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests according to ASTM standards do not involve adjudication by multiple experts in the same way clinical or AI/ML studies do. The results are quantitative measurements against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or AI systems where human readers interpret medical images. This submission is for a physical orthopedic implant.
• Effect Size: Not applicable as no such study was performed.

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

• This question is not applicable. This device is a physical pedicle screw system, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards and specifications (specifically ASTM F136 for materials and ASTM F1717 for mechanical performance). The device's performance is compared against the known performance of legally marketed predicate devices through these standardized mechanical tests.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a pedicle screw system's mechanical testing. This concept applies to AI/ML devices.

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

• This question is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided 510(k) summary describes a traditional medical device (a spinal implant) and its non-clinical mechanical testing, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of the questions related to AI/ML study design, readers, and ground truth are not relevant to this specific document. The "study" referenced is a series of mechanical tests to demonstrate substantial equivalence to predicate devices.

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