(44 days)
The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.
The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)
This 510(k) submission (K092053) for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath does not contain a study or detailed acceptance criteria for device performance.
Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market. In such cases, a detailed performance study with specific acceptance criteria is typically not required, as the safety and effectiveness are established through comparison rather than de novo testing.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in this submission. The basis for acceptance is substantial equivalence to predicate devices. | The device is deemed "as safe and effective as the predicate devices" based on the comparison presented. No quantifiable performance metrics are listed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no mention of a "test set" in the context of a performance study for this device. The submission focuses on a comparison to predicate devices, not on direct performance testing of the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no performance study with a test set generating new data was conducted, there were no experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or associated adjudication was performed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study. The comparison is made at a device level (similarity of design, materials, intended use) rather than assessing human reader performance.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a mechanical dental attachment; therefore, an "algorithm only" performance study is irrelevant.
7. Type of Ground Truth Used:
- Not applicable/Implicit. The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The new device leverages this existing regulatory record by demonstrating its similarity.
8. Sample Size for the Training Set:
- Not applicable. This is a hardware device; machine learning or AI models with training sets are not involved.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set or associated ground truth establishment process is relevant for this type of device.
Summary of the Study (or lack thereof):
The "study" in this 510(k) submission is a comparison to predicate devices (MIDWEST STRAIGHT ATTACHMENT-K792445 and NSK CONTRA ANGLE SHEATH-K962540). The applicant, Handpiece Headquarters, asserts that the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is substantially equivalent to these legally marketed devices based on:
- Device Description: Both the proposed device and the predicate devices are described as connecting between a low-speed air-driven motor and a handpiece head (1 to 1 ratio).
- Intended Use: The intended use statement for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is identical in function to what would be expected of the predicate devices: "removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth."
- Safety and Effectiveness: The conclusion explicitly states: "The Straight Attachment & Contra Angle Sheath are as safe and effective as the predicate devices as cited above."
The FDA's letter (Page 3 of the document) confirms that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination signifies that the FDA accepted the applicant's argument of substantial equivalence, meaning no new clinical or performance studies were required for this specific filing.
§ 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.