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510(k) Data Aggregation
(17 days)
The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.
The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.
The provided text describes a 510(k) premarket notification for the SOL Portable Diode Laser Unit, claiming substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The study described is a comparative performance test against predicate devices.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated for a novel device performance. Instead, the study aims to show that the new device (SOL Portable Diode Laser Unit) performs as well as or better than the predicate devices, and that all devices (subject and predicates) meet a general standard.
| Acceptance Criteria (Based on IEC 60601-2-22) | Reported Device Performance (SOL Portable Diode Laser Unit) | Reported Predicate Performance |
|---|---|---|
| Laser output should vary from the device's setting by less than ± 20% of the setting. | Average variance: | Average variance: |
| - 1.4% in Continuous Wave (CW) | - 2.2% in CW | |
| - 0.5% in Pulse (P) | - 2.7% in P | |
| Conclusion: The subject device demonstrated less variability (more control) than the cleared predicate devices, satisfying the standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings..." This implies a series of measurements across different power settings for both the subject device and two predicate devices, but the exact number of measurements or units tested is not provided.
- Data Provenance: The study was conducted for the purpose of a 510(k) submission, implied to be by the manufacturer (Den-Mat Holdings, LLC). The nature of the performance data (e.g., in-house testing) suggests it's prospective, but no specific country of origin for the data is mentioned beyond the manufacturer's location in Lompoc, CA, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This study does not involve expert evaluation for establishing "ground truth" in the clinical sense (e.g., disease diagnosis). It is a technical performance comparison based on physical measurements of laser output.
4. Adjudication Method
Not applicable. There is no adjudication method described as the study is a technical comparison of laser output measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an MRMC comparative effectiveness study. It's a technical performance comparison of a medical device against predicate devices, specifically focusing on laser output accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device (SOL Portable Diode Laser Unit) operates in a standalone manner for laser emission, the performance data presented is for the device itself (its laser output characteristics) rather than an "algorithm only" performance in the context of AI or diagnostic software. Therefore, this question, framed for AI/algorithm performance, is not directly applicable. The performance described is for the hardware's output.
7. The Type of Ground Truth Used
The "ground truth" for this study is the device's setting for laser output power, against which the actual measured output is compared. The acceptance criterion of "less than ± 20% of the setting" from IEC 60601-2-22 serves as the standard or benchmark.
8. The Sample Size for the Training Set
Not applicable. This is not a study involving machine learning or AI where a training set would be used. The performance data is derived from direct measurements of the physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
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(15 days)
To be used as a general purpose suction and/or irrigation device during open or laparoscopic surgical procedures; including general, gynecologic, thoracic, otolaryngologic, plastic and urologic.
Not Found
This FDA document is a 510(k) clearance letter for the VTI Suction Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document provided does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter is an administrative notification of clearance and refers to a premarket notification, but the content of that notification (which would contain the study details) is not included here.
Therefore, I cannot fulfill your request for the tables and study descriptions based solely on the provided text.
To answer your request, I would need access to the actual 510(k) premarket notification (K141323) submitted by Vascular Technology, Inc. to the FDA. This notification would typically include:
- A summary of the non-clinical and/or clinical performance data.
- A comparison to a predicate device, including performance data.
- The deemed acceptance criteria for performance.
- The details of any validation studies performed.
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