(105 days)
High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of this device is identical to the predicate 430 series handpiece currently marketed under 510(k) numbers K960719 and K982593.
The Solara Series High Speed Dental Handpieces are pneumatically driven, handheld devices intended for use by trained dental professionals for drilling in the oral cavity. Procedures include but not limited caries removal, restorative work and crown preparations.
This 510(k) premarket notification for the Solara Series High Speed Dental Handpieces does not contain a study section that describes acceptance criteria or a study proving the device meets said criteria in the way a modern AI/software as a medical device (SaMD) submission would.
The document is for a traditional medical device (dental handpieces) and focuses on demonstrating substantial equivalence to predicate devices rather than providing performance metrics against predefined acceptance criteria from a clinical study. The "study" mentioned here refers to the comparative analysis performed to show that the proposed device is as safe and effective as existing legally marketed devices.
However, based on the provided text, I can infer the context of "acceptance criteria" through the lens of safety and effectiveness equivalence, and describe the "study" as a comparative analysis.
Here's an attempt to structure the information based on your request, with significant caveats that many sections will be marked "Not Applicable" or "Not specified" due to the nature of this particular 510(k) submission:
Acceptance Criteria and Device Performance
This submission for the Solara Series High Speed Dental Handpieces is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices. The "acceptance criteria" are therefore inferred to be that the proposed device is as safe and effective as the predicate devices, with similar technology and design, and the same intended use and means of operation. Device performance is therefore assessed relative to the function and safety profile of the predicate.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Safety: Device is as safe as predicate devices. | "Improvements made to the proposed device were initiated to improve the handpiece performance while maintaining the safety of the device." - Implies safety is maintained at predicate level. |
| Effectiveness: Device is as effective as predicate devices for drilling in the oral cavity. | "The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have the same intended use, similar technology and design. Both devices have the same means of operation and are used for the same procedures." - Implies effectiveness is equivalent to predicate. |
| Intended Use: Device performs the stated indications for use. | "High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of this device is identical to the predicate 430 series handpiece..." - Implies all intended uses are met, identical to predicate. |
| Technology and Design Similarity: Device utilizes similar underlying technology and design principles. | "similar technology and design." - Directly stated in the substantial equivalence argument. |
| Means of Operation: Device operates in a similar manner. | "Both devices have the same means of operation..." - Directly stated in the substantial equivalence argument. |
Details of the "Study" (Substantial Equivalence Analysis)
The "study" in this context is the substantial equivalence comparison performed by the manufacturer, Star Dental Products, against their own previously cleared devices and another manufacturer's device. This is not a prospective clinical trial or a performance study with a test set as would be common for AI/SaMD.
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. There is no "test set" in the sense of a dataset of cases used to evaluate an algorithm's performance. The comparison is conceptual and based on the design, materials, and intended use of the devices.
- Data Provenance: Not applicable. The comparative analysis is based on the known specifications and performance characteristics of the proposed Solara Series handpieces and the predicate devices (StarDental 430 Series High Speed Handpiece (K960719 and K982593) and NSK TI-Max Titanium Handpiece). This is a retrospective analysis of device specifications and clinical indications, rather than a prospective study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment in the context of expert consensus on a test set of data. The "ground truth" for the predicate devices' safety and effectiveness was established through their original 510(k) clearances and their market history. The manufacturer's engineering team (Contact Person: William Guscott, Engineering Manager) performed the comparison.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication was used. The substantial equivalence determination is made by the FDA based on the provided submission.
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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 not an AI/SaMD device, and therefore no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical dental handpiece, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. This
"ground truth" was initially validated through the FDA's 510(k) clearance process for the predicate devices, which would have involved assessing their design, performance data (e.g., durability, RPM, torque, vibration), and intended use. Outcomes data, while not explicitly detailed in this document for the predicates, would have contributed to their market acceptance and the FDA's initial clearance.
- The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. This
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The sample size for the training set:
- Not applicable. This is a traditional medical device, not an algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.