(977 days)
AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.
THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED. ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.
The provided text describes a 510(k) submission for a dental handpiece (K971732). However, it does not contain any information regarding acceptance criteria, study methodologies, performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) summary/statement and the FDA's response letter indicating substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often by highlighting similar design, materials, and intended use, rather than presenting detailed clinical study data with specific acceptance criteria and performance outcomes.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.
Here's what I can extract, and why the other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | The device is described as "durable and safe," similar to existing dental handpieces. The primary claim for substantial equivalence is based on "ease of alignment in all areas of the mouth," which is stated to give it a "safety margin over any existing highspeed handpiece." However, no specific performance metrics or quantitative acceptance criteria are provided. |
Missing Information: Quantitative acceptance criteria (e.g., specific thresholds for durability, ergonomic benefits, or any other performance aspect) are not mentioned. Corresponding quantitative performance results are also absent.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe any specific test set, clinical study, or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: No information about expert involvement in establishing ground truth is provided, as no test set or study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned, as there is no description of a test set requiring 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
Missing Information: This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This is not an algorithm or software device. No standalone performance data is relevant or provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: No ground truth information is provided, as no specific study or clinical data is presented. The substantial equivalence relies on the comparison to predicate devices' known safety and efficacy, often inferred from long-standing market use (as implied by the statement "All dental handpieces, since their inception in the late 1800's, have been consructed of the same materials: brass and chrome, or stainless, or a combination of both. AALL dental handpieces have been both durable and safe.")
8. The sample size for the training set
Missing Information: No training set is mentioned or applicable to this device type and submission.
9. How the ground truth for the training set was established
Missing Information: No training set or ground truth for such a set is discussed.
Summary of Document Content:
The provided documents are a 510(k) "Substantial Equivalence" submission and the FDA's clearance letter for a dental handpiece (K971732). The basis for substantial equivalence is primarily:
- Similar materials: "Constructed of the same materials: brass and chrome, or stainless, or a combination of both" as other dental handpieces.
- Historical safety: "All dental handpieces... have been both durable and safe."
- Design feature leading to safety margin: The new handpiece's "ease of alignment in all areas of the mouth" is presented as a safety improvement over existing designs.
- Intended use: "To grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth," identical to other dental handpieces.
This type of submission often leverages known safety and performance of predicate devices without requiring new, specific clinical studies with detailed acceptance criteria or performance metrics for the new device.
§ 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.