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The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.

The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.

Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks.

Dental Handpiece Lubricant: Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.

The provided document is a 510(k) premarket notification for dental handpiece cleaners and lubricants. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria and proving performance against them in the same way a de novo device might.

Here's an analysis based on the document, addressing the requested points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, it relies on demonstrating that the subject devices perform comparably to a legally marketed predicate device. The "acceptance criteria" are implicitly that the subject device's performance in the specified tests is equivalent to or better than the predicate device's performance, allowing it to meet its design performance requirements.

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

The document does not specify the sample size used for the test set (i.e., the number of handpieces or test iterations). It simply states that "performance testing... was conducted on the subject devices and the predicate device."

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it is likely that the testing was conducted prospectively by the manufacturer or a contracted lab.

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

This type of information is generally not relevant for 510(k) submissions of accessories like handpiece lubricants. The "ground truth" here is objective physical and mechanical measurements of handpiece performance, not subjective expert assessment of clinical outcomes or images. Therefore, no experts were used in this capacity.

4. Adjudication Method for the Test Set:

Not applicable, as the "ground truth" is based on objective measurements, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human reader performance is a key metric. This device is a maintenance product for dental equipment.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical product (lubricant). Performance is evaluated based on its effect on the mechanical function of dental handpieces.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on objective physical and mechanical measurements. Specifically, the test evaluated:

• Bur extraction force
• Concentricity
• Noise level
• Torque

These are measurable performance specifications for dental handpieces, which are expected to be maintained or improved by the lubricants.

8. The Sample Size for the Training Set:

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

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

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

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The Dental Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

This document is a 510(k) summary for the Henry Schein/HHC/SCORE Canister Handpiece, indicating a premarket notification for a dental device. The primary finding is that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating equivalence rather than conducting new clinical studies with established acceptance criteria and detailed performance reporting.

Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in this document.

Here's an analysis based on the provided text, highlighting the absence of the requested clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided.
The document states: "The canister handpiece is as safe and effective as the predicate device as cited above." This is a statement of substantial equivalence, not a report of specific performance metrics against pre-defined acceptance criteria from a clinical study. No specific quantitative or qualitative acceptance criteria are listed, and no detailed performance data (e.g., accuracy, precision, durability, success rates) are reported.

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

Not applicable/Not provided.
Since no new clinical study demonstrating performance against acceptance criteria was conducted or reported, there is no test set sample size or data provenance information. The basis for equivalence is a comparison of design and functional principles with existing predicate devices.

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

Not applicable/Not provided.
No test set requiring expert ground truth establishment is mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not provided.
No test set requiring adjudication is mentioned.

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

Not applicable/Not provided.
No MRMC study was conducted or reported. The document focuses on device design and intended use equivalence, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided.
This device is a mechanical dental handpiece, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

Not applicable/Not provided.
There is no "ground truth" mentioned in the context of a clinical performance study. The ground truth for this submission is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable/Not provided.
No training set is mentioned as this is a physical device, not a machine learning model.

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

Not applicable/Not provided.
As there is no training set for an algorithm, this question is not relevant.

Summary of Device Rationale from the Document:

The basis for market clearance for the Henry Schein Canister Handpiece is substantial equivalence to an already legally marketed predicate device (SUPER-AIR S & SUPER-AIR U Handpiece Models manufactured by PENG LIM ENTERPRISE CO., Ltd.).

The document describes the device and its intended use, then states: "The canister handpiece is as safe and effective as the predicate device as cited above." This implies that by being similar in design, function, and intended use to a device already deemed safe and effective, no new, extensive clinical studies demonstrating specific performance against novel acceptance criteria were required for this 510(k) submission.

The "study" in this context is the comparison against the predicate device, not a clinical trial.

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