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The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premium Plus Prophy Air Motor. Based on the document, this is a Class I medical device (dental handpiece and accessories). For Class I devices, the level of regulatory scrutiny and required evidence of "performance" to establish substantial equivalence is generally much lower than for Class II or Class III devices, especially those involving AI/ML.

The provided document describes a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy or performance in the same way an AI/ML device would be scrutinized. Therefore, the "acceptance criteria" here relate to meeting basic safety and performance standards for a simple mechanical device and demonstrating similarity to an existing device. The "study" refers to the engineering and biocompatibility tests conducted.

Most of the specific information requested in your prompt (e.g., sample size for test set regarding AI algorithms, number of experts for ground truth, MRMC studies, standalone AI performance) is not applicable or not present in this type of submission for a simple mechanical dental device. This FDA submission is not for an AI/ML device.

Here's the closest breakdown based on the provided text:

Acceptance Criteria and Device Performance for Premium Plus Prophy Air Motor (K170261)

The Premium Plus Prophy Air Motor is a Class I mechanical dental device. The "acceptance criteria" in this context are defined by compliance with recognized international standards for dental handpieces and by demonstrating substantial equivalence to a predicate device. The "performance" refers to the device meeting the specifications outlined in these standards and its functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test (e.g., "Performance Test," "Biocompatibility Test," "Validation Testings"). These typically involve testing a representative sample of devices, but specific numbers are not provided in this summary. For Class I mechanical devices, the number of units tested is generally small as standardized tests are conducted on representative samples to ensure manufacturing quality and design integrity.
• Data Provenance: The device manufacturer, Premium Plus International Limited, is located in Hong Kong, China. The testing itself is conducted to international standards (ISO) and FDA guidance, but the exact location of the testing laboratories (e.g., in Hong Kong, or a third-party lab elsewhere) is not specified. The tests are prospective in the sense that they are performed on the device being submitted for marketing.

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

This concept is not applicable here. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where there is an interpretation or classification task. For a mechanical dental handpiece, the "ground truth" is determined by objective physical measurements and adherence to engineering standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, often for AI/ML devices or diagnostic tests. Here, the "tests" are compliance with engineering standards and validation protocols.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-driven ones, to assess how AI assistance impacts human reader performance. This device is a simple mechanical prophy air motor, not a diagnostic tool or an AI/ML product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an "algorithm" was not done. This device does not contain an algorithm or AI component. Its performance is measured directly through mechanical, airflow, and material safety tests.

7. The Type of Ground Truth Used

As this is a mechanical device, the "ground truth" is established by:

• Compliance with objective engineering standards (e.g., ISO 14457, ISO 9168).
• Results from biocompatibility assays (e.g., cytotoxicity, irritation, sensitization tests per ISO 10993 standards) where "ground truth" is defined by the test's positive/negative control and specific criteria for material response.
• Results from reprocessing validation tests (e.g., protein/hemoglobin analysis, sterilization cycles) designed to demonstrate effective cleaning and sterilization.
• Direct physical and operational measurements (e.g., dimensions, weight, air pressure, operating speed, power output) compared against specifications and the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable. This device is a mechanical product, not an AI/ML algorithm. There is no "training set" for an algorithm.

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

This concept is not applicable as there is no training set.

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Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.

The provided text is a 510(k) premarket notification from the FDA for a device called "Premium Plus Disposable Barrier Sleeve." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific acceptance criteria through a study involving diagnostic accuracy, human readers, or AI.

Therefore, the requested information about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as would be relevant for an AI/ML-driven diagnostic device, cannot be found in this document.

The document describes the physical and material characteristics of the barrier sleeves and confirms that they meet certain safety and performance standards for barrier efficacy, not diagnostic accuracy.

Here's what can be extracted from the document regarding the device's "performance" in its specific context:

Device: Premium Plus Disposable Barrier Sleeve
Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in a quantitative diagnostic performance metric (e.g., sensitivity, specificity, AUC). Instead, it compares the new device to a predicate device ("Pac-Dent Barrier Sleeve") based on various physical and biological properties relevant to its function as a barrier. The "acceptance criteria" are implied by the "Comparison of Technological Characteristics and Performance" table, where the new device is stated to be "comparable" or "equivalent" to the predicate.

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

This document does not describe studies that would have "test sets" in the context of diagnostic performance (e.g., patient data for an AI model). The "tests" mentioned are for material properties and barrier efficacy.

• Sample Size: Not specified in terms of "test set" for diagnostic performance. For mechanical and barrier tests, samples of the material/product would have been tested according to relevant ASTM/ISO standards, but specific sample numbers are not provided.
• Data Provenance: Not applicable in the context of patient data. The tests are laboratory-based material property tests.

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

Not applicable. This is not a diagnostic device or an AI/ML device requiring expert ground truth for interpretation of medical images or patient data. The "ground truth" for this device relates to established material performance standards (e.g., a material either passes or fails a tear strength test as per an ASTM standard).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

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

No. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI-assisted) on human readers' performance. This device is a physical barrier, not a diagnostic tool, so an MRMC study is not applicable.

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

No. This device is not an algorithm or an AI system. Its performance relates to its physical properties as a barrier.

7. The Type of Ground Truth Used

The "ground truth" is based on:

• Physical and Chemical Properties: Material composition (polyethylene film), thickness.
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These involve laboratory tests on cell cultures and animal models (though the document doesn't specify if human or animal data were used beyond stating "non-cytotoxic," etc.).
• Mechanical and Barrier Performance Standards: ASTM D882 (tensile strength), ASTM F1342 (puncture resistance), ASTM D1424 (tear resistance), ASTM F1670 (synthetic blood penetration), ASTM F1671 (viral penetration). These are well-defined laboratory test methods.
• Functional Testing: "Effectiveness of x-ray devices covered with Premium Plus Disposable Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices." This implies functional testing against a benchmark of an X-ray device operating without the barrier, but the specifics of this "ground truth" are not detailed.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

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Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.

Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.

This document is a 510(k) premarket notification for a dental curing light, the Premium Plus C01/C02 LED Curing Light. It aims to establish substantial equivalence to existing predicate devices. The information provided focuses on technical specifications and safety standards rather than clinical performance or AI algorithm validation.

Therefore, many of the requested details, such as acceptance criteria based on clinical metrics (e.g., sensitivity, specificity), sample size for test sets, ground truth establishment by experts, adjudication methods, or effects of AI assistance, are not applicable or not available in this document.

The document primarily relies on comparisons of technical characteristics and adherence to recognized safety and performance standards to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or human improvement with AI). Instead, it relies on demonstrating that the device meets recognized industry standards and performs comparably to predicate devices based on technical specifications and safety tests.

Therefore, instead of a clinical performance table, below are the relevant technical and safety performance criteria that were met:

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

• Sample Size for Test Set: Not specified for any clinical or performance comparison study. The document refers to "Performance Tests" for Electrical Safety, EMI, LED lamps, and Depth of Cure, but the number of units or materials tested is not mentioned.
• Data Provenance: Not applicable as there's no patient data or clinical imagery discussed. All testing appears to be laboratory-based and related to device specifications and safety.

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

Not applicable. The "ground truth" here is adherence to technical standards and specifications, not clinical diagnoses or interpretations. These standards are established by regulatory bodies and consensus organizations, not individual experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive task that would require adjudication.

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 dental curing light, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is based on:

• Compliance with recognized international and national standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights).
• Demonstrated technical equivalence in key specifications (intended use, light source, wavelength, radiant intensity, operational modes, power, environmental factors, safety standards) to already approved predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.

Not Found

I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device (Premium Plus Disposable Prophy Angle). It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training and test sets. This document is not relevant to those types of inquiries for AI/ML devices.

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