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The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. The system consists of a variety of bone plates and screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set of instruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTM F899. The system components are provided non-sterile and must be steam sterilized by the user prior to use.

Here's a breakdown of the acceptance criteria and study information for the ChoiceSpine Boomerang™ Anterior Cervical Plate System based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary indicates that mechanical testing was performed according to ASTM F1717-18. While specific numerical acceptance criteria (e.g., maximum deflection, fatigue cycles) are not detailed in the provided text, the summary states:

Missing Information: The document states "pre-defined acceptance criteria were met" but does not specify what those criteria are (e.g., specific load tolerances, cycles to failure, deflection limits per ASTM F1717-18). To fully answer this, one would need to consult the full ASTM F1717-18 standard and the original test report.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "mechanical testing" was performed but does not quantify the number of plates or screws tested.
• Data Provenance: Not specified. Mechanical testing is typically conducted in a laboratory setting, not with human patient data.

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

This question is not applicable to this type of device submission. Mechanical testing of an implantable device does not typically involve human experts to establish "ground truth" in the same way clinical studies or diagnostic AI algorithms do. The "ground truth" here is the physical performance and material properties of the device as measured by engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing outcomes are typically measured directly by equipment and analyzed by engineers, not adjudicated by experts in a consensus process.

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

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices with human readers, not for spinal implants.

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

Yes, in a sense. The "standalone" performance here refers to the device itself performing according to its design specifications through mechanical tests, without human interaction influencing the performance of the device itself. There is no algorithm being tested in this context.

7. The Type of Ground Truth Used

The ground truth used for this submission is mechanical performance data according to a recognized standard (ASTM F1717-18). This includes measurements of static and dynamic compression bending and static torsion, compared against design specifications and predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set.

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The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in sketally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 455/465 SS per ASTM A564 and 17-4 SS per ASTM F899.

The provided text is a 510(k) summary for the ChoiceSpine Stealth™ Cervical Spacer System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through comparisons of material, design, and indications for use.

Crucially, this document does NOT contain information regarding clinical studies, human-in-the-loop performance, or detailed test results with acceptance criteria and reported performance metrics that would typically be found in a study proving the device meets acceptance criteria.

The 510(k) process for this type of device (intervertebral body fusion device) generally relies on bench testing for mechanical properties and biocompatibility, as well as comparison to a predicate device. It does not typically require extensive clinical trials with human subjects to demonstrate safety and effectiveness beyond what has been established for the predicate device.

Therefore, an exhaustive answer to your request, especially sections 1 through 7 which relate to clinical performance testing and ground truth establishment, cannot be provided from this document. The document primarily focuses on equivalence rather than a new standalone performance study.

However, based on the information provided, here's what can be inferred and what cannot:

Information that CANNOT be Extracted from the Provided Text:

• A table of acceptance criteria and reported device performance (for clinical outcomes/diagnostic accuracy): This document does not describe specific clinical performance tests with defined acceptance criteria or reported values related to diagnostic accuracy, sensitivity, specificity, etc. It focuses on the physical and material characteristics and intended use compared to a predicate.
• Sample size used for the test set and data provenance (for clinical performance): Not applicable for clinical performance as no such study is detailed.
• Number of experts used to establish ground truth & qualifications (for clinical performance): Not applicable.
• Adjudication method (for clinical performance): Not applicable.
• MRMC comparative effectiveness study (for AI assistance): Not applicable, as this is a medical implant, not an AI diagnostic device.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used (for clinical performance): Not applicable.
• Sample size for training set (for an AI/algorithm): Not applicable.
• How ground truth for training set was established (for an AI/algorithm): Not applicable.

Information Extracted from the Provided Text (Relevant to Device Description and Equivalence):

1. Acceptance Criteria and Reported Device Performance (as pertains to mechanical/material properties, inferred from equivalence):

While a direct table of acceptance criteria for clinical performance is not present, the document implies acceptance by demonstrating substantial equivalence to predicate devices in terms of:

2. Sample Size and Data Provenance (for mechanical/material tests):

• The document implies that testing for mechanical properties (e.g., "PEEK spacer is the worst-case compared to the Titanium spacer which is previously tested and cleared under K091531") and sterilization validation was performed. However, specific sample sizes for these tests are not provided in this 510(k) summary.
• Data Provenance: Not specified, but standard regulatory submissions typically involve testing conducted by the manufacturer or accredited labs. The document does not mention multi-center data collection for clinical performance. The testing for substantial equivalence is generally done in a controlled, prospective manner by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as this document pertains to a medical implant and its safety/equivalence based on design, materials, and mechanical properties, not a diagnostic device requiring expert interpretation for "ground truth."

4. Adjudication Method:

• Not applicable.

5. MRMC Comparative Effectiveness Study:

• Not applicable; this is an intervertebral body fusion device, not AI software or a diagnostic tool that would typically involve human reader studies.

6. Standalone Performance:

• The "performance" discussed is related to the device's mechanical integrity, sterilization effectiveness, and biocompatibility, as compared to predicate devices. There isn't a "standalone algorithm" in this context. The device's performance is inherent to its physical properties and intended function as an implant.

7. Type of Ground Truth Used:

• For the physical device, "ground truth" relates to established standards for material properties (e.g., ASTM standards for titanium and PEEK), mechanical performance (e.g., specified load-bearing capabilities through bench testing), and biological compatibility (e.g., ISO standards for biocompatibility). The document indicates adherence to these standards (e.g., "Ti-6Al-4V ELI per ASTM F3001, Materials Class C," "PEEK-OPTIMA® polymer...per ASTM F2026").
• For sterility, the ground truth is a demonstrated Sterility Assurance Level (SAL) of 10⁻⁶, validated by testing.

8. Sample Size for the Training Set:

• Not applicable; "training set" is a concept for machine learning or AI models, which are not described here.

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

• Not applicable.

In summary, this 510(k) summary serves to demonstrate substantial equivalence of a medical implant to existing cleared devices, primarily through comparison of design, materials, manufacturing processes, and indications for use, supported by bench testing and validation (e.g., sterilization). It does not involve a clinical study with human "readers" or AI algorithms, and thus, many of the requested details about acceptance criteria for diagnostic performance or human-AI interaction are not present.

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