(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.
§ 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.