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Near-infrared Diode Laser System
The provided text is a pre-market notification (510(k)) for a medical device (SDL Diode Laser System) seeking substantial equivalence to existing devices. As such, it does not detail acceptance criteria and a study proving the device meets those criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating equivalence to predicate devices based on shared characteristics and operational principles.
Therefore, many of the requested elements for an AI device acceptance criteria and study are not applicable or directly available in this document.
However, I can extract information related to the basis of equivalence, which serves a similar function to "meeting acceptance criteria" in this context.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Study for the SDL Diode Laser System
The "acceptance criteria" for this device are not explicitly stated in a quantitative table with specific metrics of performance as they would be for an AI diagnostic device. Instead, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to predicate devices. The "study" proving this largely consists of comparisons of operating characteristics and benchtop tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit) | Reported Device Performance |
|---|---|
| Operating Characteristics (Laser System) | The SDL diode laser system has the same operating characteristics as the Diomed 25, 25W surgical diode laser system with respect to: |
- Power output
- Operating parameters
- Operating controls and indicators (touch pad controls for setting parameters, identical input power 110 VAC). |
| Fiberoptic Connector System | The SDL diode laser system uses the industry standard SMA 905 fiberoptic connector system, identical to that used by Diomedics. |
| Delivery System Efficacy (Thermal Conversion) | For NEOS family of fiberoptic delivery systems (NEOS Alloy Scalpel, Fiber Cap, Hybrid Surgical Device) and Bipolar Dissector: - Mechanism: Surface treatment completely absorbs laser energy, converting light energy into thermal energy regardless of wavelength.
- Benchtop Study Result: Temperature profiles of a NEOS Alloy Scalpel tip (at 3.5 and 6.5 watts) were equivalent when used with a diode laser or a 1.06µ Nd:YAG laser system.
For Closed End and Closed End/Electrocautery systems:
- Mechanism: Swaged stainless steel hypo tubing converts light energy into thermal energy, regardless of wavelength. |
| Tissue Thermal Effects (Clinical Equivalence) | Reference Study (Judy et al., 1993): Comparisons of depths of thermal coagulation in rabbit tissues obtained with a diode laser and a 1.06µ Nd:YAG laser using contact fibers supported the equivalency of tissue thermal effects. |
| Operational Controls (User Interface) | The SDL diode laser system can be operated by either a footswitch or a fingerswitch, a technology equivalent to and offered since 1990 on Nd:YAG laser systems by Surgical Laser Technologies and LCA. |
| Compliance with Standards | Conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. (Certification reports to be submitted). |
| Labeling Compliance | Product labels comply with 21 CFR 1040.10, 1040.11, and 801 as applicable. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable in the context of an AI device’s test set. The "test" here is largely a comparison of specifications and a benchtop study.
- Benchtop Study: The text mentions "Laboratory bench top studies were performed to compare temperature profiles of a NEOS Alloy Scalpel tip." The number of "samples" (e.g., number of tips tested, number of measurements) is not specified.
- Clinical Study (cited): A study by Judy et al. (1993) on "rabbit tissues" is cited. The specific sample size within that study (e.g., number of rabbits, number of tissue samples) is not provided in this document.
- Data Provenance:
- Benchtop Study: Unspecified. Assumed to be conducted by SLT-J, Ltd. or associated entities.
- Clinical Study (cited): Judy et al., 1993; published in "Lasers in Surgery and Medicine." The study would be prospective in nature, using fresh rabbit tissue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document does not describe an "expert ground truth" establishment process for a diagnostic test set. The equivalency claim relies on observable physical characteristics, engineering specifications, and a cited scientific study.
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication of a "test set" for a diagnostic outcome is described.
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 a laser system, not an AI diagnostic device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Benchtop Study: Direct physical measurements (temperature).
- For Cited Clinical Study (Judy et al.): Direct observation and measurement of "depths of thermal coagulation" in rabbit tissues, likely histopathological analysis. Not expert consensus in the sense of a diagnostic image review.
8. The Sample Size for the Training Set
- Not Applicable. This device uses engineering design and predicate device comparison, not machine learning with a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" or corresponding ground truth for this type of device submission. The functionality is based on established physics and previous device designs.
§ 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.