(263 days)
The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "
The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
The provided text describes a 510(k) submission for a dental device, the "Bosworth Air Polisher." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics and acceptance criteria in the same way a novel device might.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission in the provided document. The "study" here is primarily a comparison to a predicate device and limited performance testing to support basic functionality.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for a 510(k) are typically based on demonstrating equivalent performance or safety to a predicate device, as opposed to establishing specific numerical thresholds for clinical outcomes. The "performance" described here relates to functional tests rather than clinical efficacy.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Device is intended for "cleaning & polishing of teeth by the projection of water, air, & dental powder onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth." | Met: The Bosworth Air Polisher has the identical intended use: "a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface." The Predicate Device is also an "Air Polisher." |
| Technological Equivalence | Device shares similar operating principle, function, cleaning/preparatory action, delivery control, activation, water/air supply, sterilization process with the predicate device. | Met: Both the Bosworth Air Polisher and the predicate device (EMS Air-Flow Master Standard) have an "identical operating principle: Projection of a powder, water, and air spray stream onto the tooth-surface-provides-the-cleaning-and-polishing-action." Detailed comparison in "Comparison Chart for Determination of Substantial Equivalence" shows high similarity. |
| Durability/Reuse Life | Support a minimal reuse life (e.g., specific number of treatments or hours of use). | Met: "The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use." |
| Connection Integrity | Demonstrate that the turbine tube connection remains intact when subjected to specified air pressures. | Met: "The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of human subjects or teeth. The tests described are functional engineering tests.
- Data Provenance: The tests were conducted internally by the manufacturer, Harry J. Bosworth Company. The document does not specify country of origin for any "data" beyond the company's location in Skokie, Illinois, USA. The testing is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for the tests described are engineering specifications and functional outcomes (e.g., connection remaining intact, completing 130 treatments). These are not clinical outcomes requiring expert adjudication in the same way as, for example, image interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are functional/engineering in nature, formal adjudication by multiple experts for a "test set" is not relevant or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not performed or described. This type of study is typically conducted for diagnostic devices or AI-assisted interpretation, which is not the nature of this dental hand-held device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a mechanical dental handpiece, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this device. The device is the "algorithm" in that its mechanical function is its performance.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Outcomes: The "ground truth" for the performance testing cited (reuse life, connection integrity) refers to successful completion of engineered stress tests against predefined functional criteria.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and performance are based on mechanical engineering principles, comparison to a predicate, and specified functional tests.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth established for one. The "ground truth" for the device's design is the established performance and safety record of the predicate device and relevant engineering standards.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.