Search Results
Found 1 results
510(k) Data Aggregation
(65 days)
Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are indicated for the preparation of dental cavities for restorations, such as fillings.
The Access™ L & KL and RotaMax™ L & KL Fiber Optic High Speed Dental Handpieces and Accessories are indicated for use in the preparation of dental cavities for restorations, such as fillings. These handpicces arc a scries of fiber optic high speed, air-driven turbine handpieces for use with standard size burs in accordance with ISO 1797. The technological characteristics and form/fit/function of the Access™ L & KL and RotaMax™ L & KL handpieces, respectively, are substantially equivalent to the Bien-Air Prestige L & LK Turbine Handpieces (FDA-cleared via K983183) and the Bora L & LK Turbine Handpieces (FDA-cleared via K983183).
The Access™4 series have a stainless steel ball bearing turbine with rotational speeds of up to 335,000 rpm and a smaller head as compared to the RotaMaxTM models. The Access™ is available for use with a Sable 6 Hole, 360° Swivel Quick Connect Coupler or Multiflex™ Coupler. The handpiece also contains a triple spray cooling system. The three air and water ports are located within the detachable diffuser. The diffuser is replaceable and is easily removed for cleaning. The Access™ incorporates an anti-retraction valve within the handle. The handpiece is autoclavable to 135° C. The Access™ has a patented nonheating, push button chuck bur-changing mechanism. The dual glass optics consist of a single block of optic rods. The glass rods are angled to help reduce shadows on the tooth. The fiber-optic light unit is fully interchangeable.
The RotaMax™ series have a ball bearing turbine with rotational speeds of up to 310,000 rpm and a larger head as compared to the Access™ models. The RotaMax™ is available for use with a Sable 6 Hole, 360° Swivel Quick Connect Coupler or Multiflex™ Coupler. The handpiece also contains a triple sprav cooling system. The three air and water ports are located within the detachable diffuser. The diffuser is replaceable and is easily removed for cleaning. The RotaMax™ incorporates an anti-retraction valve within the handle. The handpiece is autoclavable to 135° C. The RotaMax™ also has a patented nonheating, push button chuck bur-changing mechanism. The dual glass optics consist of a single block of optic rods. The glass rods are angled to help reduce shadows on the tooth. The fiber-optic light is fully interchangeable.
The electronic fiber optic control board available for use with the Access™ and RotaMax™ series handpieces is for one or two handpieces and supplies an adjustable power output ranging from 2 - 3.5 volts. The control board has an adjustable illumination time delay ranging from 0.5 - 4.5 seconds for each handpiece.
A range of air hoses are available for use with the Access™ and RotaMax™ series handpieces. The connectors for these hoses meet the criteria either for Type B or C per ISO 9168, and therefore have five outlets (to accommodate drive-air & exhaust, fiber optic, spray-air, and irrigation) or four outlets plus electrical contacts (to accommodate drive-air & exhaust, fiber optic power supply, sprayair, and irrigation). The air hoses arc straight and come in various colors.
KaVo Spray (preamendments device) or other FDA-cleared lubricants may be used to lubricate the Access™ L & KL and RotaMax™ L & KL Fiber Optic High Speed Dental Handpieces.
The provided text is a 510(k) Summary for dental handpieces and accessories. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI/ML device.
Instead, the document focuses on demonstrating substantial equivalence through conformity with established performance and safety standards for medical devices.
Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Information Not Provided in Text".
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Numerical Acceptance Criteria | The device's performance is demonstrated through conformity with a range of ISO and IEC standards for medical devices. Explicit numerical performance metrics with defined acceptance thresholds are not provided. |
| Conformity to ISO 7785-1 (High-speed Air Turbine Handpieces) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to ISO 9168 (Dental Handpieces Hose Connections) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to ISO 1797-1 (Dental Rotary Instruments Shanks) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to ISO 11134 (Sterilization of health care products) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to ISO 10993 Part-1 (Biological Evaluation of Medical Devices) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to IEC 60601-1 (Medical Electrical Equipment Part 1: General requirements for safety) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
| Conformity to IEC 60601-1-2 (Medical Electrical Equipment Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility) | "Conformity with the above standards demonstrates that the Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not Applicable. The document does not describe a clinical "test set" in the context of an AI/ML development. The "performance and safety" assessment is based on conformity to engineering and medical device standards, which would involve testing according to those standards, but not a patient-data-based test set as typically understood for AI/ML.
- Data Provenance: Not Applicable.
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 information is not relevant to the type of device (dental handpiece) and the type of evidence presented (conformity to standards, not AI/ML performance on clinical data).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept relates to expert review of clinical cases for ground truth establishment, which is not described.
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. The device is a dental handpiece, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant here. The "ground truth" for this device's safety and effectiveness is its compliance with recognized industry standards for dental handpieces, sterilization, biocompatibility, and electrical safety.
8. The sample size for the training set
- Not Applicable. This device is not an AI/ML model, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This device is not an AI/ML model, so there is no training set or associated ground truth establishment process.
Ask a specific question about this device
Page 1 of 1