(125 days)
Cavity Preparation Removal of decayed and sound tooth structure Removal of restoration materials Prep for pit and fissure sealant Modification of enamel and dentin for increased bond strength
The Jetstream System is a pneumatic device which combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The Jetstream is capable of removing dental caries, old composite restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a highspeed dental drill. The Jetstream consists of a console, handpiece, and a footswitch. Specifications for the Jetstream System are provided in the table below. The console houses the system pneumatics, simple, easy to use controls, and canisters for holding the particulate supply. The system is designed for easy service and maintenance with easily accessed and refillable canisters for the particulate supply.
This document does not contain the information requested for acceptance criteria and study details.
The provided text is a "Summary of Safety and Effectiveness Information" (a 510(k) premarket notification) for a dental device called the "Jetstream Cavity Preparation System." This type of document is used to demonstrate substantial equivalence to existing devices, not to present a detailed study proving the device meets specific acceptance criteria in the way you've described.
Here's why the information is missing:
- Acceptance Criteria/Performance Table: The document provides a comparison table of features between the Jetstream and predicate devices, but this is a comparison of specifications, not a table of pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy, precision) and the performance of the device against those criteria.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states: "As of September 1995, Dove Systems, Inc. conducted a database search of the published literature to identify adverse use experience with cavity preparation systems. This literature review revealed the following adverse event experience with cavity preparation systems." This indicates a literature review was performed for adverse events, not a dedicated study to assess the Jetstream's performance against specific metrics. There is no mention of a test set, training set, ground truth establishment, expert involvement, or any form of a comparative effectiveness study.
- Training Set Sample Size/Ground Truth: Not applicable as no specific study of the device's diagnostic or performance metrics is described.
Instead, the document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices by comparing technical specifications (e.g., cutting material, velocity settings, operating modes) and noting similar indications for use and adverse event profiles. The conclusion is based on this comparison, not on a new clinical performance study.
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MAR - 7 1996
Appendix V Summary of Safety and Effectiveness Information
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Section 510(k) Premarket Notification
Summary of Safety and Effectiveness Information
Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name:
Dove Systems, Inc. 4280 Higuera Road San Jose, CA 94328 (408) 223-2418
Company Contact Requlatory Affairs:
Arthur Vassiliadis, Ph.D. Dove Systems, Inc. 4280 Higuera Road San Jose, CA 94328 (408) 223-2418
Device Name:
Jetstream Cavity Preparation System.
Predicate Devices:
KCP 2000 Cavity Preparation System (American Dental Laser, Trov, Michigan) Microprep Cavity Preparation System (Sunrise Technologies, Inc.) Kv-1 Cavity Preparation System (Kreativ, Inc.)
Device Description:
The Jetstream System is a pneumatic device which combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations .
The Jetstream is capable of removing dental caries, old composite restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a highspeed dental drill.
The Jetstream consists of a console, handpiece, and a footswitch. Specifications for the Jetstream System are provided in the table below. The console houses the system pneumatics, simple, easy to use controls, and canisters for holding the particulate supply. The system is designed for easy service and maintenance with easily accessed and refillable canisters for the particulate supply.
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Comparison With Predicate Device:
| FEATURE | Jetstream | Microprep | Kv-1 | KCP 2000 | SE? |
|---|---|---|---|---|---|
| Cutting material | Aluminum OxidePowder 50µ particles | Aluminum OxidePowder 50µ particles | Aluminum OxidePowder 27µ & 50µparticles | Aluminum OxidePowder 27µ & 50µparticles | Yes |
| Velocity settings | Continuously Variable40-120 psi | Continuously Variable80-120 psi | ContinuouslyVariable 40-120 psi | Slow, Medium, High(40-120-140) psi | Yes |
| Delivery medium | Compressed Air - Wallsource | Compressed Air -Internal Compressor | Compressed Air -Wall source | Compressed Air -Wall source | Yes |
| Operating modes | Pulse & Continuous | Pulse & Continuous | Pulse & Continuous | Continuous Only | Yes |
| Evacuation | Other Evacuator | Proprietary -"Quickevac" | Other Evacuator | Built In | Yes |
| Electrical | 100-240V, 50/60 Hz | 110-220-240V 50/60 Hz | 100-240V, 50/60 Hz | 110V | Yes |
| Controls | Touch Pad MembraneSwitches | Touch Pad MembraneSwitches | Touch PadMembrane Switches | Touch PadMembrane Switches | Yes |
| Delivery system | Handpieces | Handpieces | Handpieces | Handpieces | Yes |
| Indications | Cavity PreparationRemoval of decayedand sound toothstructureRemoval of restorationmaterialsPrep for pit and fissuresealantModification of enameland dentin forincreased bondstrength | Cavity PreparationRemoval of decayedand sound toothstructureRemoval of restorationmaterialsPrep for pit and fissuresealantModification of enameland dentin for increasedbond strength | Cavity PreparationRemoval of decayedand sound toothstructureRemoval ofrestoration materialsPrep for pit andfissure sealantModification ofenamel and dentin forincreased bondstrength | Cavity PreparationRemoval ofdecayed and soundtooth structureRemoval ofrestoration materialsPrep for pit andfissure sealantModification ofenamel and dentinfor increased bondstrength | Yes |
| K-Number | Pending | K932997 | K940776 | K921748 | Yes |
Summary of Adverse Product Experience:
As of September 1995, Dove Systems, Inc. conducted a database search of the published literature to identify adverse use experience with cavity preparation systems. This literature review revealed the following adverse event experience with cavity preparation systems.
- Cutting of adjacent soft tissue. 1.
- Subcutaneous injection of air and/or air and abrasive particles. 2.
- Etching of adjacent tooth surface. 3.
- Reduced effect on existing gold or amalgam restorations ব .
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- Infection
Additional Information
A bibliography of selected articles is available from Dove Systems, Inc. upon request.
Conclusions:
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Based on the comparison of the technical specifications of the Jetstream Cavity Preparation System with the KCP 2000 Kinetic Cavity Preparation System, the Microprep Cavity Preparation System, and with the Kv-1 Cavity Preparation System, the company concludes that the Jetstream Cavity Preparation System is substantially equivalent. Dove Systems, Inc. believes that the Jetstream Cavity Preparation System may reasonably be expected to be safe and effective when used according to its labeling by properly trained individuals. The adverse events identified with the use of the Jetstream are the same or similar to the adverse events associated with the use of the referenced equivalent devices.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”