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The T2™ Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of a series of end caps, baskets, and covers which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.

The T2TM Spinal System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.
The T2 XVBR™ expanding cage is made of titanium alloy, cobalt chrome, and nitinol. The T2 XVBR™ end caps, baskets, and covers are attached to the T2 XVBR™ expanding cage to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

T2™ Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.

This document is a 510(k) summary for the T2™ Spinal System, which is a medical device. Based on the provided text, it's not a study proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/diagnostics device. Instead, it's a submission to demonstrate substantial equivalence to previously cleared devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) submission asserting substantial equivalence to predicate devices, not a performance study against specific acceptance criteria. The "performance" being demonstrated is the T2™ Spinal System's similarity in intended use, technology, and safety/effectiveness to existing devices.

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

Not applicable. No test set or data provenance related to a performance study is described. The submission is based on comparison to predicate devices, material testing, and design specifications.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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 device is a physical spinal implant, not an AI or diagnostic tool.

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

Not applicable. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable. No ground truth as typically understood for a performance study is described. The basis for clearance is "Substantial Equivalence" to legally marketed predicate devices, meaning the device's design, materials, and intended use are comparable to already approved devices.

8. The sample size for the training set

Not applicable. No training set is described.

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

Not applicable. No training set or ground truth establishment for it is described.

Summary of the K082112 510(k) Pre-market Notification (T2™ Spinal System):

This document is a 510(k) summary for a vertebral body replacement system. The core of this submission is to demonstrate substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, based on similarities in intended use, technological characteristics, and performance (often demonstrated through bench testing and material compatibility, though not detailed here).

The FDA's letter (pages {2} and {3}) confirms that a substantial equivalence determination was made, allowing the device to be marketed. This regulatory pathway does not typically involve a clinical performance study with acceptance criteria and a test set like those for AI or diagnostic devices. Instead, the "proof" is in the successful demonstration of equivalence to existing, approved devices.

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The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays in Dental Radiography.

The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography. The system is comprised of the following main components: X-ray tubehead, Yoke with user interface capabilities, Articulation arm, Horizontal arm, Electronic control unit (which my be mounted remotely), Wall mount, 8" or 20cm cone. Optional components include: 8 ft. coil cord with exposure switch, 55" and 65" reach option, Optional cone lengths and shapes. The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.

The provided text describes a 510(k) premarket notification for the Gendex 765DC Intraoral Dental X-Ray System, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria. As such, the information required for a comprehensive answer to your request is largely absent in the document.

However, I can extract and infer some information based on the typical requirements for such submissions and what is explicitly stated.

Acceptance Criteria and Device Performance Study (Based on Submitted Document)

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC that are typical for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

The "study" described is a regulatory submission process rather than a standalone clinical trial with quantifiable acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document refers to "Performance testing to meet product specifications" and "Effective clinical image exposures" but does not detail the size of any test sets used in these evaluations.
• Data Provenance: Not specified. It's likely that any performance testing or clinical image evaluations would have been conducted internally by the manufacturer (Gendex Dental X-Ray Division of Dentsply International, Inc.) or contracted labs. The document does not indicate country of origin for data or if it was retrospective/prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "Effective clinical image exposures," implying evaluation by dental or radiology professionals, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a 510(k) for an X-ray system (which focuses on device safety and performance characteristics rather than diagnostic interpretation by an AI), a formal adjudication method for a test set of interpretations is unlikely to be discussed in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, the document does not mention an MRMC study. This type of study is typically done for diagnostic AI devices where human performance changes with AI assistance. The Gendex 765DC is an X-ray imaging system, not an AI diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was reported and the device is not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Not explicitly in the sense of an "algorithm only" performance. The device is a hardware system (X-ray machine). The "Software testing to validate software design / performance" would be similar to a standalone evaluation of the device's internal software functions, but not an independent diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The document refers to "Effective clinical image exposures." For an X-ray system, the ground truth would typically relate to:
  • Image Quality Metrics: Resolution, contrast, signal-to-noise ratio, dose-to-image quality relationship, absence of artifacts.
  • Compliance with Standards: Meeting electrical, radiation safety, and performance standards.
  • Clinical Efficacy (Inferential): The ability to produce images suitable for diagnostic tasks, as judged by experts (though not explicitly detailed here).
    No specific "pathology" or "outcomes data" ground truth is mentioned in relation to proving the device's utility, as it is a foundational imaging tool.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is an X-ray system, not an AI model that undergoes a "training" phase with a dataset. Any internal software development would not use a "training set" in the AI sense.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.

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