(206 days)
The Pilot Diode Laser is indicated for the procedures of
- Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
And - Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
The Pilot Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid state diodes capable of producing laser energy at 810 ± 20nm for a maximum of 9 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided text describes a 510(k) summary for the Pilot Diode Laser and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific clinical study with granular performance metrics against a defined acceptance criterion.
Therefore, many of the requested elements for describing a study that proves the device meets acceptance criteria are not explicitly present in the provided text.
However, I can extract the available information and highlight what is missing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Criterion | Reported Device Performance |
|---|---|---|
| Output Wavelength | Consistent with predicate devices (810nm range). | 810 ± 20nm |
| Maximum Energy Output | Sufficient for intended uses and comparable to predicate devices. | Maximum of 9 watts of energy output. |
| Delivery System | Optical fiber system for safe transmission. | Proprietary optical fiber system, contained within a metal handpiece with a disposable single-use tip. |
| Aiming Beam | Present and adjustable. | Switchable 630nm aiming beam, adjustable power output for both working beam and aiming beam. |
| Delivery Mode | Continuous or pulse delivery option. | Continuous delivery or pulse delivery option. |
| Activation Method | Foot-actuated switch. | Foot-actuated switch. |
| Applicable Standards Compliance | Compliance with relevant federal and international safety and performance standards (e.g., 21 CFR 1040.10, 1040.11, IEC 60601-1, etc.). | Complies with 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, July 26, 2001). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, UL60601-1, 47 CFR 15 and 18, and ETSI 301-489-1. |
| Effectiveness for Indications for Use | Deliver laser energy necessary for the specified indications (soft tissue procedures and temporary relief of minor pain/stiffness/etc.). | "This device was tested and found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use. The device was tested and passed CAO Group internal requirements for construction and performance." The document further states, "The Pilot Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics." This implies it also meets effectiveness for "Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue" by virtue of substantial equivalence to predicate devices with these indications. |
Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., "power output must be 9W +/- 0.5W") nor detailed quantitative performance data for these criteria beyond general statements like "deliver laser energy necessary." It refers to compliance with standards and internal requirements, but the specifics of those are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "The Pilot Diode Laser tested as compliant" and "This device was tested and found to deliver laser energy necessary," but it does not describe a clinical study with a test set of data or participants. The testing appears to be based on engineering and safety compliance rather than clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The assessment described in the document is primarily about device specifications, safety standards, and functional characteristics rather than diagnostic or therapeutic efficacy requiring expert ground truth on a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided, as no clinical test set requiring adjudication 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
This information is not applicable/not provided. The device is a surgical/therapeutic laser, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to human reading performance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical laser system, not an algorithm. Its performance is inherent to its output and delivery, not an autonomous algorithmic decision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a clinical study that would require a ground truth of these types. The "ground truth" implicitly used for the performance claims appears to be adherence to engineering specifications and regulatory standards, and the ability to emit laser energy suitable for the stated indications, as verified by internal testing and compliance with external standards.
8. The sample size for the training set
This information is not applicable/not provided. There is no mention of a "training set" as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no "training set."
Summary of the "Study" (as described in the document):
The document primarily describes a technical compliance and substantial equivalence study.
- Objective: To demonstrate that the Pilot Diode Laser is substantially equivalent to legally marketed predicate devices without raising new issues of safety or effectiveness.
- Methodology:
- Comparison to Predicate Devices: Analysis of design features, wavelength, control systems, safety features, performance monitoring, power output, applications, and indications for use against three predicate devices (Velure Family of Diode Lasers, DenLaser 800 Plus, THOR VR Single Diode Laser Treatment Probe).
- Compliance Testing: The device was tested for conformity to various international and federal standards:
- 21 CFR 1040.10 and 1040.11 (with permissible deviations per Laser Notice 50)
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-22
- IEC 60825-1
- UL60601-1
- 47 CFR 15 and 18
- ETSI 301-489-1
- Internal Performance Testing: "The device was tested and passed CAO Group internal requirements for construction and performance."
- "Acceptance Criteria" (Implicit):
- Meet or be comparable to the technical specifications and safety features of predicate devices.
- Comply with all listed regulatory and performance standards.
- Demonstrate the ability to deliver laser energy necessary for the specified indications for use.
- "Results": The device was "tested as compliant" with the listed standards and "found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use." The conclusion was that the device is "substantially equivalent" to the predicate devices.
§ 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.