(78 days)
The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.
The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.
The provided document describes a 510(k) summary for Sharplan CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication. It does not provide detailed acceptance criteria or a comprehensive study report with the requested specifics. However, based on the available information, I can extract and infer some points:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" are provided in a quantitative table format as per a typical performance study. Instead, the document focuses on demonstrating "substantial equivalence" to predicate devices.
| Acceptance Criteria (Inferred from "substantial equivalence") | Reported Device Performance |
|---|---|
| Same technology as predicate CO2 lasers | Identical technology |
| Same intended use as predicate CO2 lasers | Same intended use |
| Same intended use as predicate surgical scalpel | Same intended use |
| No significant differences in overall performance characteristics compared to predicates | Sharplan Lasers, Inc. believes no significant differences exist. |
| Safety and Effectiveness demonstrated (based on clinical results and historical data) | Clinical results from 80 patients at 2 sites, plus historical data, were presented to demonstrate safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 80 patients
- Data Provenance: Obtained at 2 sites. The document does not specify the country of origin but implies a clinical study was conducted. It is a prospective collection of clinical results for this submission, augmented by "historical data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "clinical results" but does not detail how the outcomes of the myringotomy/tympanostomy procedures were evaluated or by whom, nor does it specify the qualifications of any experts involved in establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
An MRMC study is not applicable here as the device is a surgical laser, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable for a surgical laser. The device itself performs the surgical task, and its performance is evaluated based on the clinical outcome of the procedure, not as a standalone algorithm in a diagnostic context.
7. The Type of Ground Truth Used
The document mentions "Clinical results from 80 patients." This implies that the ground truth for evaluating the safety and effectiveness of the device was based on clinical outcomes observed in patients who underwent the procedure using the Sharplan CO2 Laser. Further details on specific metrics (e.g., successful tympanostomy, complication rates, healing) are not provided.
8. The Sample Size for the Training Set
This information is not applicable as this is a medical device submission, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for a medical device in this context.
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Image /page/0/Picture/0 description: The image shows the text 'NOV - 5 1996'. The text is in bold and appears to be part of a document or label. The date is likely a reference to when the document was created or when the label was printed. The image is simple and straightforward, with the text being the main focus.
Image /page/0/Picture/1 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a stylized circle with a pie chart-like design on the left, followed by the word "SHARPLAN" in large, bold, sans-serif font. Below "SHARPLAN" is the text "LASERS, INC." in a smaller, sans-serif font. The entire logo is in black against a white background.
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510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Sharplan CO2 Laser Systems for Laser Assisted Myringotomy/ Tympanostomy Indication is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel .
- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance August 16, 1996
- Model: Sharplan Models 20c, 30c, and 40c CO2 Lasers 2 .
- Predicate Devices: The Sharplan CO2 Lasers which are intended for use in ENT and 3 . the ScalpelTEC, Inc. Myringotomy Safety Scalpel.
- The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers 4 . Description: are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.
- The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to 5 . the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.
Clinical results from 80 patients, which were obtained at 2 sites, were presented as part of this 510(k) submission, along with historical data, in order to demonstrate the safety and effectiveness of the device.
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510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication (continued)
- From a design and clinical perspective, the predicate and candidate laser devices, are of the same technology (they are identical), and have the same intended use. The other predicate device, which is a surgical scalpel, has the same intended use as the candidate device. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this expanded indication should not raises any concerns regarding the safety or effectiveness of the Sharplan Lasers, Inc. CO2 Laser Systems for a Laser Assisted Myringotomy/Tympanostomy Indication
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.