(90 days)
Not Found
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.
{0}------------------------------------------------
Summary of Safety and Effectiveness V.
Summary of 21 CFR 807.87
A. Device Name:
-
- Proprietary Name:
K960905
- Proprietary Name:
JUN - 3 1996
SDL Diode Laser System and Associated Fiberoptic Delivery Systems
- Common Name:
Near-infrared Diode Laser System
- B. Establishment Registration Number:
SLT-J, Ltd. has not yet registered as a medical device establishment with the FDA. The company intends to complete all regulatory filings prior to introducing the SDL diode laser system into interstate commerce.
Address all correspondence to: Mr. Michael D. Johnson iohnson + associates -5848 Price Road Milford, OH 45150 513-248-8804
- C. Device Classification:
Diode surgical laser systems are currently considered Class II medical devices subject to pre-market notification provisions for many surgical applications.
Although not formally classified, diode surgical laser delivery systems typically have been regulated as Class II devices.
{1}------------------------------------------------
Electrosurgery handpieces (pencils, electrodes) are considered Class II 79 GEI [21 CFR 878.4400]. SLT-J, Ltd. anticipates these accessory devices would receive the same classification if such energy delivery systems were officially classified.
D. Compliance With Standards
The SDL diode laser conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. Certification reports will be submitted to CDRH certifying compliance with this standard and are currently in preparation and will be submitted by SLT-J, Ltd. prior to commercial distribution of this product.
E. Labeling
Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. An Operator's Manual for the SDL diode laser system is currently in preparation. A draft Operator's Manual is included in this submission (See Attachments).
Product labels comply with 21 CFR 801 as applicable for ... accessory devices. Copies of the proposed text for these package labels are located in Section IV of this submission.
F. Statement of Equivalence
In the opinion of SLT-J, Ltd., the SDL diode laser system, when used with any of the following fiberoptic delivery systems:
NEOS Alloy Scalpel (K#914197) LCA, Inc. (Cincinnati, OH)
{2}------------------------------------------------
Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH)
Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH)
Closed End (K#931070) LCA, Inc. (Cincinnati, OH)
Closed End/Electrocautery (K#932272) LCA, Inc. (Cincinnati, OH)
Bipolar Dissector (K#901365) LCA, Inc. (Cincinnati, OH)
is substantially equivalent to the use of any of the abovementioned devices when used with any of the following medical devices which are used as a laser (energy) source:
Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX)
ZOE Nd: YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH)
Section III of this submission provides information in support of this equivalence claim.
This belief of equivalence is based upon the following facts:
-
- The SDL diode laser system has the same operating characteristics as the diode laser system offered by Diomedics Inc with respect to power output, operating parameters and operating controls and indicators. The SDL diode laser system incorporates touch pad controls
{3}------------------------------------------------
for setting of operating parameters, uses identical input power (110 VAC) as the Diomed 25W diode laser system offered by Diomedics Inc. (The Woodlands, TX).
-
- The SDL diode laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector system used by Diomedics (The Woodlands, TX). The delivery system which will be used with the SDL diode laser system will be able to directly attach to the fiberoptic connector system.
-
- Due to the technologies used in the manufacturing of the NEOS family of fiberoptic delivery systems as well as the Bipolar Dissector, the laser system used with these products is not a dependent variable to achieve a desired tissue effect. The particular surface treatment used on the NEOS Alloy Scalpel, Fiber Cap, Hybrid Surgical Device and the Bipolar Dissector, provide a product which completely absorbs the laser energy, thus converting laser light energy into thermal energy, regardless of the wavelength of the laser light source.
The Closed End and Closed End/Electrocautery fiberoptic delivery systems use swaged stainless steel hypo tubing to convert light energy transmitted through the fiberoptics into thermal energy, again regardless of the wavelength of the laser light source.
Laboratory bench top studies were performed to compare temperature profiles of a NEOS Alloy Scalpel tip with respect to the use with a diode laser or a 1.06u Nd:YAG laser system. Temperature plots were made at typical power settings of 3.5 and 6.5 watts. The maximum temperatures obtained using both laser devices were equivalent. These studies support the belief that the NEOS family of fiberoptic delivery systems and the
{4}------------------------------------------------
Bipolar Dissector can be used with a variety of sources of energy (i.e. - many different laser wavelengths) due to their surface coatings which makes these devices true heat sources independent of input laser wavelength.
In 1993, Judy et al reported a study in which comparisons of the depths of thermal coagulation in rabbit tissues obtained with a diode laser and a 1.06u Nd:YAG laser using contact fibers. Results of this study support the equivalency of tissue thermal effects obtained with the diode and Nd: YAG lasers in a contact mode; and support the use of the diode laser as an alternative medical device.
-
- The SDL diode laser system can be operated by either a footswitch or a fingerswitch. This technology is equivalent to, and has been offered since 1990 on Nd:YAG laser systems offered by Surgical Laser Technologies (The Oaks, PA) and LCA (Cincinnati, OH). This allows the operator to select between either footswitch or fingerswitch control of the fiberoptic delivery system.
{5}------------------------------------------------
Bibliography
Absten GT, Joffe SN. Lasers in Medicine - An Introductory Guide. 2nd ed. London: Chapman and Hall, Ltd, 1989.
Dixon, JA. Surgical Applications of Lasers. 2nd ed. Chicago: Year Book Medical Publishers, Inc, 1987.
Joffe SN, Oguro Y. Advances in Nd:YAG Laser Surgery. New York: Springer-Verlag, 1988.
Joffe, SN. Lasers in General Surgery. Baltimore, Maryland: Williams & Wilkins, 1989.
Judy MM, Matthews JL, Aronoff BL, Hults DF. Soft Tissue Studies With 805nm Diode Laser Radiation: Thermal Effects With Contact Tips and Comparison With Effects of 1064nm Nd: YAG Laser Radiation. Lasers in Surgery and Medicine, 13:528-536 (1993).
§ 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.