(88 days)
Attachments are used in conjunction with a 20R "E" type slow speed handpiece motor to prepare carious teeth for restorations; to perform prophylaxis or other general procedures performed by the dentist in the oral cavity or in a laboratory environment.
Athena nosecones include models to fit "E" type slow speed motors, Midwest and Star slow speed handpiece in two versions, the standard 1:1 non-reduction model and the 4:1 speed reduction model. These have four ball bearing construction; durable stainless steel chuck and operating mechanism. Uses standard handpiece burs, disposable and metal prophy angles.
Athena contra angles include models to fit "E" type slow speed motors and Midwest slow speed handpieces. "E" type models include a standard 1:1 non-reduction model and three speed reduction models 4:1, 16:1 and 64:1. The Midwest version is a 16:1 speed reduction. They convert a straight handpiece to an angle for increased access in the oral cavity. The reduction angles use stainless steel gears and four ball bearings for durability and longevity. Uses latch type heads.
The provided text describes the acceptance criteria and the study conducted for Athena dental handpiece attachments (nosecones and contra angles).
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on the sterility and durability of the dental handpiece attachments.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility: Achieve sterility after autoclaving. | Sterile: Spore strips tested sterile by Namsa after a 12-minute cycle at 132°C and 210 kPa pressure in a Pelton & Crane Validator 8. |
| Durability (Life Cycle): Withstand a minimum number of sterilization cycles. | Minimum Life Cycle: 500 cycles when autoclaved for 12 minutes at 132°C and 210 kPa pressure. |
2. Sample Size Used for the Test Set and Data Provenance:
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Sterilization Test:
- Sample Size: "one each of the above named devices" was used for the spore strip insertion. The named devices are: Compact Nosecone, 1:1 Contra Angle, 64:1 Contra Angle, Heavy Duty 1:1 Straight Nosecone, and Heavy Duty 4:1 Straight Nosecone. This suggests a total of 5 devices were tested for sterilization effectiveness.
- Data Provenance: The study was conducted at Athena Technology, Inc. in San Dimas, CA, USA. The biological testing was performed by Namsa in Irvine, CA, USA. The data is prospective as it describes a specific test conducted for this submission.
-
Life Cycle Estimates:
- Sample Size: Not explicitly stated. The document mentions "The Athena Compact Nosecone, 1:1 Contra Angle, 64:1 Contra Angle, Heavy Duty 1:1 Straight Nosecone and Heavy Duty 4:1 Straight Nosecone have estimated minimum life cycles of 500 cycles". This implies internal testing or engineering estimates without specifying the number of units tested.
- Data Provenance: Not explicitly stated, but presumably from internal testing by Athena Technology, Inc. This would be prospective data if it was a dedicated test, or based on historical/internal engineering data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Sterilization Test: The "ground truth" for sterility was established by the biological testing facility, Namsa. While the exact number of experts isn't specified, Namsa is a professional testing laboratory, implying qualified personnel. The report from Namsa confirmed sterility.
- Life Cycle Estimates: No external experts are mentioned for establishing the life cycle estimates. This appears to be an internal estimate by the manufacturer.
4. Adjudication Method for the Test Set:
- Sterilization Test: There was no explicit adjudication method described. Namsa, as the independent biological testing facility, provided the definitive result ("spore strips tested sterile").
- Life Cycle Estimates: Not applicable, as this was an internal estimate.
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:
This document describes a medical device (dental handpiece attachments), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable, as this device is a mechanical tool and not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Sterilization Test: The ground truth for sterility was based on biological indicator testing (spore strips) cultured by a professional laboratory (Namsa). This is a definitive, objective measure of sterility.
- Life Cycle Estimates: The ground truth for durability is based on engineering estimates/testing of the number of autoclave cycles the devices can withstand. While objective to a degree, the term "estimated" suggests it might not be as rigorously defined as biological testing.
8. The Sample Size for the Training Set:
Not applicable, as this device is a mechanical tool and does not employ a training set for machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for this 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.