(88 days)
The Sunrise Curing Lamp is indicated for use in curing of composite resin materials for restoration of cavity preparation, curing of bonding materials, and any application where a conventional halogen curing lamp would be used.
The Sunrise Curing Lamp is a high intensity light source that is filtered and transmitted through a liquid optical fiber to the tooth for curing of composite resins.
The provided text describes a 510(k) submission for the Sunrise Curing Lamp, comparing it to a predicate device, the ADT 1000 Plasma Arc Curing System. However, the information provided focuses on technical specifications and substantial equivalence, not on the performance of the device against specific acceptance criteria in a clinical study as would be expected for a diagnostic AI/ML device.
Therefore, many of the requested items cannot be extracted directly from this document.
Here's an analysis based on the provided text, highlighting what is present and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Sunrise Curing Lamp) |
|---|---|
| Curing Power Output: 270mW to 850mW | 400mW ± 50mW |
| Duration: 10 sec. to 25 sec. | Default 10 sec.; Adjustable 1 to 99 sec. |
| Optical Bandwidth: 430nm to 500nm | 420nm to 500nm |
| Light Source: Xenon short arc lamp | Xenon short arc lamp |
| Beam Delivery: Liquid Light Guide | Liquid Light Guide |
| Intended Use: Curing composite resins, bonding materials, etc. (same as predicate) | Indicated for use in curing of composite resin materials for restoration of cavity preparation, curing of bonding materials, and any application where a conventional halogen curing lamp would be used. |
Explanation of Inferred Criteria:
The document states, "Based on the favorable comparison of the technical performance specifications of the Sunrise Curing Lamp with the ADT 1000 Plasma Arc Curing Lamp, the company concludes that these substantially equivalent devices are safe and effective." This implies that the technical specifications of the predicate device serve as the de facto acceptance criteria for the new device. The Sunrise Curing Lamp's reported performance falls within or is comparable to these specifications, supporting its claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document describes a medical device (curing lamp), not a diagnostic AI/ML system that would typically undergo a study with a test set of data. The "study" here is a comparison of technical specifications to a predicate device.
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 / Not provided. No ground truth establishment by experts is mentioned, as this is a technical equivalence submission for a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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
- No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For this type of device, the "ground truth" for proving effectiveness would likely involve material science testing on cured composite resins (e.g., hardness, bond strength) rather than clinical outcomes or diagnostic accuracy. However, this document relies on substantial equivalence to a predicate device based on technical specifications.
8. The sample size for the training set
- Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set ground truth is mentioned.
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K962192 ✓
SEP 3 1000
SUNRISE
TECHNOLOGIES
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
| Regulatory Authority: | Safe Medical Devices Act of 1990, Section 513.21 CFR 807.92 |
|---|---|
| Company Name: | Sunrise Technologies, Inc.47257 Fremont Blvd.Fremont, CA 94538(510) 623-9001 |
| Device Name: | Sunrise Curing Lamp |
| Predicate Device: | ADT 1000 Plasma Arc Curing System |
| Device Description: | The Sunrise Curing Lamp is a high intensity light sourcethat is filtered and transmitted through a liquid optical fiberto the tooth for curing of composite resins. |
| Intended Use: | The Sunrise Curing Lamp is indicated for use in curing ofcomposite resin materials for restoration of cavitypreparation, curing of bonding materials, and anyapplication where a conventional halogen curing lampwould be used. |
| Comparison WithPredicate Device: | See accompanying table. |
| Additional Information: | A bibliography of selected articles is available from SunriseTechnologies, Inc. upon request. |
| Conclusion: | Based on the favorable comparison of the technicalperformance specifications of the Sunrise Curing Lampwith the ADT 1000 Plasma Arc Curing Lamp, the companyconcludes that these substantially equivalent devices aresafe and effective when used by properly trainedindividuals. |
Sunrise Technologies, Inc. ________________________________________________ Date
Sunrise Curing Lamp 510(k)
Sunrise Curing Lamp 510(k)
00043
Sunrise Technologies, Inc. • 47257 Fremont Boulevard, Fremont, CA 94538 • (510) 623-9001 FAX (510) 623-9008
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EQUIVALENCE IV:
A. General
The Sunrise Curing Lamp is substantially equivalent to the ADT 1000 Plasma Arc Curing System marketed by American Dental Technologies, Inc., San Carlos, California. The table below compares the features of these two equivalent systems. Please see Section 15 for a copy of predicate device ADT 1000 Plasma Arc Curing System Operator Manual.
| Features | ADT 1000 Plasma ArcCuring System | Sunrise Curing Lamp |
|---|---|---|
| Power Input | Provided by KCP 1000 | 115V~, 50/60 Hz, 2A230 V~, 50/60 Hz, 1 A |
| Light Source | Xenon short arc lamp | Xenon short arc lamp |
| Curing Power Output | 270mW to 850mW | 400mW ± 50mW |
| Duration | 10 sec. to 25 sec. | Default 10 sec.Adjustable 1 to 99 sec. |
| Optical Bandwidth | 430nm to 500nm | 420mm to 500nm |
| Beam Delivery | Liquid Light Guide, 1.7mLength.Rotating Handpiece.Fiber-optic Tip, 6.5 mm dia. | Liquid Light Guide, 1.8m LengthRotating HandpieceFiber-optic Tip, 6mm dia. |
| User Controls | Footswitch (for KCP 1000) | Power ON/OFF - Switch on frontpanelDuration set - Increment/ decrementtouchpads on front panelLight ON/OFF - Switch onhandpiece |
| Calibration | Port on front panel. | Prompted at each power ONsequencePort on front panel |
| Indicators | Two 7 segment LED digitalindicators, curing time inseconds. | Power ONCalibration2 digit display (curing time inseconds). |
Sunrise Curing Lamp 510(k)
§ 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.