(123 days)
PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.
PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors.
This document, K131014, is a 510(k) Premarket Notification for a dental handpiece lubricant, PANA SPRAY Plus. It is not a document about an AI/ML medical device, and therefore, most of the requested information regarding AI/ML device testing criteria (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to this submission.
The acceptance criteria and study proving device performance for the PANA SPRAY Plus are based on demonstrating substantial equivalence to a predicate device through non-clinical testing for reliability and durability.
Here's the information that can be extracted from the provided text, adapted to the context of this non-AI/ML device:
Acceptance Criteria and Device Performance:
- Acceptance Criteria: The device was evaluated to confirm it met "NSK America internal requirements for reliability (package vibration, unit drop, and temperature testing) and durability (repeated usage, actual usage, and contra/turbine testing)."
- Reported Device Performance: "The test results indicate that PANA SPRAY Plus met all NSK America internal requirements and is therefore substantially equivalent to the predicate device."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests | Reported Performance |
|---|---|---|
| Reliability | Package vibration testing | Met NSK America internal requirements |
| Unit drop testing | Met NSK America internal requirements | |
| Temperature testing | Met NSK America internal requirements | |
| Durability | Repeated usage testing | Met NSK America internal requirements |
| Actual usage testing | Met NSK America internal requirements | |
| Contra/turbine testing | Met NSK America internal requirements |
Information Not Applicable or Not Provided for This Device (Common to AI/ML Device Submissions):
- Sample size used for the test set and the data provenance: Not specified for this type of non-clinical testing (e.g., for mechanical/chemical lubricant).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for lubricants is physical/chemical performance, not expert interpretation.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI/ML device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
- The type of ground truth used: For this device, the "ground truth" would be the fulfillment of pre-defined engineering and performance specifications for a lubricant (e.g., lubricating properties maintained after various stress tests, no adverse effects on handpiece function, package integrity). The document refers to "NSK America internal requirements."
- The sample size for the training set: Not applicable (this is not an AI/ML device; there is no training set).
- How the ground truth for the training set was established: Not applicable.
§ 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.