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510(k) Data Aggregation
(126 days)
SABLE INDUSTRIES, INC.
Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.
A. Premium Slow Speed 20K Air Motor w/ Internal Air & Water:
The Sable Premium Slow Speed Air Motor is used in conjunction with accessories such as contra-angle and straight attachments that are manufactured in accordance with ISO 7785-2. This premium slow-speed air-driven motor is capable of running up to a speed of 20,000 RPM at 43.5 PSI (3 Bar). It does not require a separate coupler and interfaces with Midwest-type 4-hole tubing. The motor has an integrated locking mechanism for easy connection and removal of any attachment. The motor can deliver both chip air and water to assist with the removal of debris from the cutting area in the oral cavity when used in conjunction with an ISO designed attachment with internal air and water lines.
B. Slow Speed & Premium Slow Speed Heads (push button and switch latch)
The Sable Premium Slow Speed Heads are used in conjunction with attachments (Contra-angles and straight) and slow speed motors manufactured in accordance with -ISO-7785-2 and ISO 13294 respectively. These heads have an integrated locking mechanism for easy connection and removal of any attachment. These heads can be used with a variety of different latch burs conforming to the specifications of ISO 1797-1" +These heads are capable of running up to a speed of 40,000 RPM at 42 PSI (3 Bar) and have a 1:1 gear/drive ratio. These heads may be used with attachments capable of delivering both chip air and water when used in conjunction with an ISOdesigned air or electric motor with internal air and water.
C. Premium Slow Speed Contra-Angles (1:1 Fiber Optic and Non-Fiber Optic Ball Bearing w/ Internal Air & Water):
The Sable Premium Slow Speed Contra-Angles are used in conjunction with components such as slow speed heads and slow speed motors manufactured in accordance with ISO 7785-2-and ISO 13294, respectively. The fiber optic version produces 25,000 LUX for a shadow-less view of the oral cavity. These contraangles have an integrated locking mechanism for easy "snap-on" connection and removal from the motor. These contra-angles can be used with Sable premium slow speed heads which are attached / removed by a "quick-twist" locking mechanism on the contra Angle. These contra-angles are capable of running up to a speed of 40,000 RPM at 43.5 PSI (3 Bar) and have a 1:1 gear/drive ratio. These contra-angles deliver both chip air and water when used in conjunction with an ISO-designed air or electric motor with internal air and water.
D. Premium Slow Speed Straight Nosecones (1:1 Ball Bearing w/ Internal Air & Water):
The Sable Premium Slow Speed Straight Nosecones are used in conjunction with slow speed motors manufactured in accordance with ISO 13294 These nosecones have an integrated locking mechanism for easy connection and removal from the motor and can be used with a variety of different burs conforming to the specifications of ISO 1797-1. These nosecones are capable of running up to a speed of 40.000 RPM at 42 PSI (3 Bar) and have a 1:1 gear/drive ratio. These nosecones deliver both chip air and water when used in conjunction with an ISO-designed air or electric motor with internal air and water.
This document describes the 510(k) summary for Sable Industries' Premium Slow Speed Dental Handpieces & Accessories.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't specify numerical "acceptance criteria" in the format of a typical medical device study with specific performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or diagnostic device. Instead, the device's "acceptance criteria" appear to be conformity with established international standards for dental handpieces and sterilization. The "reported device performance" is implicitly that the device meets these standards, thus demonstrating it is as safe and effective as predicate devices.
| Acceptance Criteria (Compliance to Standard) | Reported Device Performance (Implicitly Met) |
|---|---|
| ISO 13294 Dental Handpieces – Dental Air Motors | Conforms to standard |
| ISO 7785-2 Dental Handpieces – Part 2: Straight & Geared Angle Handpieces | Conforms to standard |
| ISO 9168 Dental Handpieces – Hose Connections | Conforms to standard |
| ISO 3964 Dental Handpieces – Coupling Dimensions | Conforms to standard |
| ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Conforms to standard |
| ISO 11134 Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization | Conforms to standard |
| ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing | Conforms to standard |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a medical device (dental handpieces), not a software or AI-driven diagnostic device. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI studies is not applicable here. The evaluation is based on engineering design, materials, and mechanical performance tests to ensure compliance with the stated ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this type of device is established by compliance with international engineering and safety standards, not by expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. There is no diagnostic "test set" that requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI or diagnostic tool that involves human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical dental handpiece, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this medical device is compliance with established international engineering, manufacturing, and safety standards (e.g., ISO 13294, ISO 7785-2, ISO 9168, ISO 3964, ISO 17665-1, ISO 11134, ISO 10993-1).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI or machine learning algorithm. The design and manufacturing process would involve engineering specifications, testing of prototypes, and quality control of production units.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an AI algorithm, there's no ground truth established in that context. The design of the device is based on established engineering principles and adherence to the aforementioned ISO standards, which themselves represent an agreed-upon "ground truth" for safe and effective dental handpiece design and performance.
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(65 days)
SABLE INDUSTRIES, INC.
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.
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