Search Results

substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.

The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems.

This document, "Summary of Safety and Effectiveness F.", does not describe a study involving an AI/Machine Learning device or a device with performance metrics that would typically be associated with acceptance criteria in the manner requested.

Instead, this document is a 510(k) Pre-market Notification for the DCL8 Enhanced Pulsed Nd: YAG laser system. The purpose of this document is to demonstrate "substantial equivalence" to other legally marketed devices, rather than to establish specific performance acceptance criteria based on a clinical study with a test set, ground truth, and expert evaluation.

Therefore, I cannot provide the information requested in the format specified because:

1. Acceptance criteria and reported device performance: This document does not outline specific performance metrics (e.g., sensitivity, specificity, AUC) for the DCL8 laser system that would be compared against acceptance criteria. Its acceptance is based on substantial equivalence to predicate devices, focusing on similar intended use and technological characteristics.
2. Sample size used for the test set and data provenance: No test set or associated data is mentioned, as this is not a performance study.
3. Number of experts used to establish ground truth and qualifications: Ground truth establishment is not relevant in this context.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is not an AI-assisted diagnostic device.
6. Standalone performance study: Not applicable in the context of substantial equivalence for a medical laser system.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission (510(k)) for a laser system seeking market clearance based on substantial equivalence, not a performance study for an AI/ML device.

Ask a specific question about this device

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

• 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.

Ask a specific question about this device

substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.

The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. The DCL8 Enhanced Pulsed Nd: YAG laser system can be operated by either a footswitch or a fingerswitch.

This document is a 510(k) Premarket Notification for a medical device, specifically a Pulsed Nd:YAG Laser System. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already legally marketed in the U.S., rather than to establish performance against specific acceptance criteria through a clinical study as would be required for a PMA (Premarket Approval) or De Novo submission.

Therefore, the sections requesting acceptance criteria and a study proving their fulfillment are not applicable in the context of this document. This submission does not provide the information requested in the prompt because it falls under a different regulatory pathway.

Here's a breakdown of why the requested information cannot be found in the provided text:

• Acceptance Criteria & Reported Device Performance: This submission aims to prove the device is as safe and effective as existing devices, not to meet pre-defined performance thresholds demonstrated through new clinical data.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these points relate to specific clinical study designs and data collection strategies. A 510(k) typically relies on engineering comparisons, performance testing to recognized standards (like electrical safety), and a declaration of substantial equivalence based on the predicate device's established safety and effectiveness.

Instead, this document focuses on the following:

1. Device Description:
* Device Name: DCL8 Enhanced Pulsed Nd:YAG Laser System and Associated Fiberoptic Delivery Systems
* Common Name: Pulsed Nd:YAG Laser System
* Classification: Class II medical device for the laser system; accessory delivery systems expected to be Class II.

2. Compliance with Standards:
* The DCL8 system conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
* Product labels comply with 21 CFR 1040.10, 1040.11, and 801.

3. Equivalence Statement (the core of a 510(k)):
* Predicate Devices:
* SunLase Master Pulsed Nd:YAG laser system, Sunrise Technologies, Inc.
* SunLase Pulsed Nd:YAG laser system, Sunrise Technologies, Inc.
* PulseMaster 600 Pulsed Nd:YAG laser system, American Dental Technologies
* PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies
* Basis for Equivalence:
* Intended Use: Substantially equivalent to other pulsed Nd:YAG laser systems for incision, excision, coagulation, or vaporization of soft tissues in open, endoscopic, and laparoscopic procedures.
* Operating Characteristics: Same average power to tissue, pulse rates, operating controls, indicators, red diode aiming beam, touch pad controls, and input power (110 VAC) as predicate devices.
* Delivery Systems: Uses industry standard SMA 905 fiberoptic connector system, identical to predicate devices. Many delivery systems to be used with DCL8 (NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery, Bipolar Dissector, Super Scalpel, Fiber Contact Handpiece) have already received market clearance for use with other Nd:YAG laser systems. The interaction with tissue is considered independent of the laser source.
* User Interface: Can be operated by footswitch or fingerswitch, a technology offered on existing Nd:YAG laser systems since 1990.

In summary, this document is a regulatory submission for substantial equivalence, not a report on a study designed to meet specific performance acceptance criteria.

Ask a specific question about this device