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510(k) Data Aggregation
(171 days)
The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.
The Cocoon Hygienist is a dental operative unit that provides the dentist with primary requirements for dental operations. The delivery system is designed to be used as an interface device to connect the dental operating hand instruments to the appropriate supply utilities such as air, water suction, drain, and electricity. The unit is supplied with controls that allow the dentist. dental hygienist, or operator to set the water flow to the hand pieces. The water flow of the syringe, directly connected to main water supply, depends on the input water pressure. The output air pressure is preset in the unit.
The provided text is a 510(k) summary for the Satelec Cocoon Hygienist, a dental operative unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance testing with quantitative metrics as might be found for a novel or more complex medical device.
Based on the provided document, here's what can be extracted and what cannot be determined:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The technical characteristics of the Cocoon Hygienist are almost identical to those of the Boyd Industries Inc., Dental Operative Units (K020833)." |
| Functionality (supply utilities, serve as base for dental tools) | "The Cocoon Hygienist is a dental operative unit that provides the dentist with primary requirements for dental operations." "The intended use... is to supply utilities to and serve as a base for dental tools and accessories for the dental professional." |
| Safety and Effectiveness | "Differences that exist between the systems relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the Cocoon Hygienist." |
| Given the nature of a 510(k) for a Class I dental operative unit, specific quantitative acceptance criteria (e.g., minimum flow rates, pressure ranges, durability cycles) and detailed study results demonstrating performance against these criteria are not typically included in the summary. The "acceptance criteria" here are primarily met by demonstrating substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary for a device like this focuses on design comparison and functional equivalence to a predicate, not on a clinical or performance study with a test set of data points or patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. This typically applies to studies involving human interpretation (e.g., image analysis, diagnosis), which is not relevant for a dental operative unit's 510(k) submission.
4. Adjudication Method for the Test Set
This information is not provided, as there is no mention of a test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
This information is not provided. MRMC studies are relevant for diagnostic devices where human readers interpret results, which is not the case for this dental operative unit.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This information is not provided. This device is a mechanical/electrical unit, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence claim is effectively the performance and safety profile of the predicate device (Boyd Industries Inc., Boyd Delivery Units K020833). The manufacturer asserts that the technical and functional characteristics of the Cocoon Hygienist are "almost identical" and that minor differences do not affect safety or effectiveness, thus relying on the established history of the predicate. No specific pathology, outcomes data, or expert consensus was used as "ground truth" for this particular submission.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no mention of a "training set" in the context of device development or validation for this type of medical device submission. Training sets are typically associated with machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reasons as point 8.
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