(127 days)
High Speed Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
High Speed Handpieces and Accessories include 45° High Speed Handpieces, 90° High Speed Handpieces and Couplings. The models of 45° High Speed Handpieces are A45series (A45L, A45, A45M4) and 90° High Speed Handpieces are A6series (A6KL, A6L, A6, A6M4, A6B2), A5series (A5KL, A5K, A5L, A5, A5M4, A5B2), A4series (A4, A4M4, A4B2), A3series (A3, A3M4, A3B2), E-6510series (E-6510K, E-6510N), E-6500series (E-6500K, E-6500N), E-6110series (E-6110K, E-6110N), E-6100series (E-6100K, E-6100N), HPXseries (HPX4CML-Ti, HPX4CQ, HPX4CQ-Ti), HPMseries (HPM1CML, HPM1CQ, HPM1C4, HPM1C2, HPM1S4, HPM1S2) and HPKseries (HPK1C2, HPK1S4, HPK1S2). And the accessories of High Speed Handpiece are Couplings, the models of Accessories are Q6series (Q6M, Q6M-LED, Q6K, Q6K-LED, Q6KW), Q5series (Q5K), Q4series (Q4K, Q4M, Q4Q), Q2series (Q2Q), CKseries (CK4010, CK4000) and CNseries (CN4010, CN4000).
This looks like a 510(k) premarket notification for a dental device, specifically "High Speed Handpieces and Accessories." The document demonstrates substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving performance through a standalone study with ground truth.
Therefore, many of the requested categories in your prompt are not applicable to the information provided in this 510(k) summary. I cannot extract information related to:
- Sample size used for the test set and data provenance: This is not a study proving a diagnostic or AI device's performance against a ground truth. The tests are for engineering specifications.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no diagnostic ground truth being established.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as this is a physical dental device, not an AI or diagnostic tool.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the acceptance criteria and reported device performance from the "Non-clinical Testing" section and the "Comparison of Technical Features" table, as these relate to the device's engineering specifications.
Here's a summary of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
The document states: "All the test results demonstrate the performance of High Speed Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." While specific numerical "acceptance criteria" and "reported performance" are not presented side-by-side in a table in the exact format you requested for each test, the document implies that the device passed the tests outlined by the referenced standards.
From the "Comparison of Technical Features" section, we can infer performance characteristics based on comparison to predicate devices, which serve as a benchmark for "acceptance" in a 510(k) context.
| Feature | Predicate Device Performance (Implied Acceptance Criteria) | Proposed Device Performance (Reported Performance) |
|---|---|---|
| Operational Modes | Air-powered | Air-powered |
| Water Spray | Single/Triple (K033213), Single (K130455), N/A (K945734, K102517) | Single/Triple/Quattro |
| Coupling Pin | 2-pin/4-pin/6-pin (K033213, K945734); 4-pin/6-pin (K130455); 5-pin (K102517) | 2-pin/4-pin/5-pin |
| Fiber Optics | With light/Without light (K033213, K130455, K945734); With light (K102517) | With light/Without light |
| Dimensions (mm) - Length | 84~117 (K033213) | 84~117 |
| Dimensions (mm) - Width | 19~21 (K033213) | 19~21 |
| Accessories | With coupling/without coupling (K033213); With coupling (K130455); N/A (K945734, K102517) | With coupling/without coupling |
| Composition of Main Materials | Stainless steel, Brass, Aluminum, Titanium (K033213) | Stainless steel, Brass, Aluminum, Titanium |
| Chuck Design | Push Button (K033213, K130455) | Push Button |
| Light Intensity | 25,000 lux to 32,000 lux (K033213) | 25,000 lux to 32,000 lux |
| Bur Extraction Force | 22N~45N (K033213, K130455) | 22N~45N |
| Maximum Air Pressure | 1.5 l/min at 200kPa (2bar) (K033213, K130455) | 1.5 l/min at 200kPa (2bar) |
| Maximum Water Pressure | 50ml/min (K033213, K130455) | 50ml/min |
| Speed in rpms | 350,000 rpm to 380,000 rpm (K033213); 400,000rpm (K130455) | 350,000 rpm to 400,000 rpm |
In addition, the device successfully completed non-clinical testing according to the following standards, indicating it met the acceptance criteria defined within those standards:
- ISO 14971:2007 Medical devices Application of risk management to medical devices
- ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
- ANSI/AAMI ST79:2010/A3:2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3
- AAMI/ANSI/ISO 17665-1:2006/(R)2013 – Sterilization of health care products – moist heat - part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.
- ISO 11138-3:2006 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat
- ISO 14457:2012 Dentistry - Handpieces and Motors
- ISO 10993-1:2009 - Biological Evaluation of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
- ISO10993-5:2009 – Biological evaluation of medical devices – tests for in vitro cytotoxicity
- ISO 10993-10:2010 - Biological evaluation of medical devices - tests for intracutaneous irritation and skin sensitization
- Guidance for Industry and FDA Staff-Dental Handpieces-Premarket Notification[510(k)] Submissions
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to recognized standards, rather than detailing a specific experimental test set. The manufacturer is based in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical dental instrument, not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a physical dental instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device like this, "ground truth" would relate to its manufacturing specifications and performance against engineering standards, not diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a traditional device submission, not an AI/machine learning device that involves training sets.
9. 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.