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The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver.

The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The device is provided sterile and is for single use only.

The document provided does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a clinical trial or performance study with detailed statistical results. Instead, it is a 510(k) Premarket Notification from the FDA to Propel Orthodontics, LLC, confirming substantial equivalence of their PROPEL Device to a predicate device.

The information primarily focuses on comparing the PROPEL device's features to a predicate device (Synthes 90° Screwdriver, K082649) to demonstrate substantial equivalence, rather than setting specific performance acceptance criteria and then validating against them with a dedicated study.

However, based on the provided text, I can extract information related to "acceptance criteria" in the sense of compliance with standards and "reported device performance" from bench testing, and information about the evidence used to support substantial equivalence.

Here's an analysis based on the structure of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, "acceptance criteria" here refer more to compliance with recognized standards and successful completion of bench tests, rather than explicit numerical thresholds for clinical performance.

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

The document does not detail specific sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients or cases). The "supporting data" section refers to:

• Bench testing: Conducted to demonstrate performance, but no sample sizes (e.g., number of devices tested for reliability) are provided.
• Clinical literature article: Only one article is cited ("Alikhani M, Rapis M, Soldan B, et al. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 144:639-48; 2013."). The provenance of data within this article (country of origin, retrospective/prospective) is not specified in the 510(k) summary. This is presented as existing published literature, not a study specifically commissioned for this 510(k) submission with a freshly collected test set.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a process of establishing ground truth by experts for a specific test set. The clinical literature cited (Alikhani et al.) would have its own methodology and expert involvement, but this is not detailed in the 510(k) summary.

4. Adjudication Method

Not applicable. There is no mention of a ground truth adjudication method as there is no specific test set undergoing expert review described.

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

No. The document presents a comparison of the PROPEL device to a predicate device (Synthes 90° Screwdriver) for substantial equivalence based on technological characteristics and intended use, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a manual drilling tool, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

No. This is a physical medical device (a manual drill), not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests (biocompatibility, sterilization, shelf-life, electrical safety, bench tests), "ground truth" is defined by compliance with established international and national standards (ISO, ASTM, IEC) and the device's own product specifications.

For the claim of being able to create holes in alveolar bone, the "ground truth" is supported by a citation to published clinical literature.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices like a manual bone drill.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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