(86 days)
Use in combination with attachments, i.e., a nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparations or other procedures used by a dentist in the oral cavity.
20R "E" type slow speed dental handpiece motor; fully autoclavable (up to 135°C); utilizes an E type coupling to accept standard E type attachments. ISO couplings B, C and D are available.
This 510(k) summary describes a dental handpiece motor and demonstrates its substantial equivalence, primarily focusing on sterilization effectiveness and life cycle. It does not present a typical device performance study with specific acceptance criteria directly comparable to clinical efficacy metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by successful sterilization and estimated durability.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Effectiveness | Complete sterility after autoclaving | Passed: Spore strip cultured at Namsa for 7 days showed 0 positive articles (no growth of Bacillus stearothermophilus). Conclusion: "TEST ARTICLE MEETS THE REQUIREMENTS OF THE STERILITY TEST." |
| Autoclavability | Withstand repeated autoclaving cycles without loss of function | Passed: Device is "fully autoclavable (up to 135°C)." |
| Minimum Life Cycle | Not explicitly stated as an "acceptance criterion" | Estimated: "The Athena 20R "E" Type Slow Speed Motor has an estimated minimum life of 500 cycles when autoclaved for 12 minutes at 132 degrees Celsius and 210 kPa pressure." (This is an estimate, not a proven acceptance criterion in this context, but indicates durability.) |
| Material Biocompatibility | Medical grade materials, commonly used in medical/dental devices | Passed: Aluminum (Type 2011/6016) and stainless steel (300/416 series) conform to ASTM specifications. VITON is a "medical grade, FDA approved elastomer." Flourosilicone is "commonly used." |
Note: The primary "study" described is the Sterilization Test and Analysis, which directly addresses the critical safety aspect of being able to be rendered sterile.
2. Sample Size Used for the Test Set and Data Provenance
- Sterilization Test Sample Size:
- One Athena 20R "E" type motor was physically disassembled for the spore strip insertion and then reassembled and autoclaved.
- Six spore strips (identified as "Spore Strip" in the Namsa report table) were incubated to test for sterility.
- Two positive control spore strips were used.
- Data Provenance: The study was conducted by Athena Technology, Inc. at their facility in San Dimas, CA, using a Pelton & Crane Validator 8 autoclave. The biological testing (incubation of spore strips) was performed by Namsa, located in Irvine, CA. This is a prospective test specifically for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No external experts were explicitly stated to establish "ground truth" for the sterilization test. The "ground truth" was established by objective laboratory culture methods for bacterial growth.
- The biological testing facility, Namsa, is a professional independent lab specializing in medical device testing. Their staff (e.g., Frank Zuklic, M.S. who approved the report) would be qualified microbiologists or similar specialists responsible for conducting and interpreting such tests according to established procedures (USP Methods or client's procedures).
4. Adjudication Method for the Test Set
- None. For the sterility test, the result is objective: either bacterial growth occurred (positive) or it did not (sterile). There is no "adjudication" necessary in the sense of reconciling differing expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human readers assess images or data, and AI assistance is being evaluated. The Athena 20R "E" Type motor is a mechanical dental tool, not an interpretative diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in essence, the described sterilization test is a standalone performance test of the device's ability to be sterilized. There is no "human-in-the-loop" component being evaluated for this specific performance characteristic. The device itself (plus spore strip) was subjected to the sterilization process, and its sterility was objectively measured.
7. The Type of Ground Truth Used
- The "ground truth" for the sterilization test was objective biological culture results. The absence of bacterial growth on the spore strips after incubation indicated sterility.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical dental handpiece. It does not use algorithms that require a "training set" of data in the manner of AI/ML devices for image analysis or diagnostic support.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.