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510(k) Data Aggregation
(242 days)
1550nm laser:
Indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including menscus cartilage, in conjunction with an imaging modality for medical specialties including: General Surgery, Orthopedics, Podiatry, Arthroscopy and Spinal Surgery.
980nm laser:
Indicated for use to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Regenalase is a portable console that houses a fiber laser operating at 1550 nm wavelength and a diode laser operating at 980 nm wavelength. The system utilizes a wired one-pedal footswitch for hands-free laser activation. The console consists of the 1550 nm laser module, the 980 nm laser module, control electronics, optical module, air cooling, and a touch screen display.
The laser energy for the 1550 nm laser is delivered via previously cleared commercially available laser fibers. The fibers come in two different sizes.
The 980 nm laser is used with a fiber delivery system, consisting of the Universal Stage One handpiece and four different attachments.
This looks like a 510(k) summary for a medical laser system. Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics like a typical software or AI device study would. Instead, it describes various non-clinical tests and their outcomes, aimed at demonstrating substantial equivalence. The "acceptance criteria" are implied by the conformance to standards and the comparability to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1550 nm Laser: | |
| Similar thermal damage to predicate device (1470 nm laser) | "The results show that the two devices produced comparable thermal damage." (ex vivo study) "The data show that the induced damage was comparable between the subject and predicate devices for comparable energy deposition." (Thermal Performance Evaluation) |
| Pulse duration within safe and effective range (subset of predicate) | "The Subject device's pulse durations fall within the range of the Predicate device's pulse durations. All possible combinations of power and pulse duration of the Subject device are a subset of all possible combinations of power and pulse duration of the Predicate device. Therefore, there are no new additional questions of safety and effectiveness raised since all the Predicate device's possible combinations of power and pulse duration are equivalent to those of the Predicate device." |
| Pilot beam wavelength does not raise safety concerns | "The Subject device differences in pilot beam wavelengths, both being visible, do not raise any different concerns for safety." |
| General Device: | |
| Risk management adherence | "Risk management was performed according to ISO 14971 Third Edition 2019-11 Medical Devices -Application of risk management to medical devices and the FDA Guidance Document." |
| Electrical safety & electromagnetic compatibility | "The device conforms to the following standards: IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-22 Edition 3.1 2012-10, IEC 60825 Edition 2.0 2007-03." |
| Software verification and validation | "Software verification and validation testing was conducted and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices' and in ANSI/AAMI/IEC 62304:2006/A1:2016...results were found acceptable for software release." |
| Human factors evaluation | "Human Factors...confirmed using ANSI/AAMI/IEC 1:2015+AMD1 2020 (Consolidated Text) Medical Devices Part 1 Application of Usability engineering to medical devices...results found to be acceptable." |
| Biocompatibility of patient-contacting materials | "Biocompatibility testing was conducted...in compliance with ISO 10993-1 and the FDA Guidance...results of the tests indicated that all success criteria were met with no issues." |
| Bench testing (power output, beam quality, environmental, safety control) | "Testing shows that the device delivers set energy parameters within specifications and performs as intended." |
| Overall safety and effectiveness compared to predicate | "Comparison between the Regenalase Laser System and the predicate device shows that the Regenalase Laser System is as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The only specific "test set" mentioned in terms of data collection for performance comparison is for the thermal performance evaluation, which used "three ex vivo tissue samples." No other specific sample sizes for tests like electrical safety, software validation, or human factors are given.
- Data Provenance: The thermal performance evaluation was an ex vivo study (meaning performed on tissue outside a living organism). The country of origin is not specified, but the manufacturer is based in Marlborough, MA, USA.
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. For a laser system primarily demonstrating physical effects (like thermal damage), the "ground truth" is typically the measured physical effect itself (e.g., thermal damage depth/width). There's no mention of expert human readers or reviewers establishing ground truth for performance metrics.
4. Adjudication Method for the Test Set:
This information is not provided. Given that the thermal performance evaluation relied on physical measurements rather than subjective human assessment, an adjudication method for reconciling expert opinions would likely not be relevant or necessary.
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 type of study is typically done for AI/software devices that assist human readers in tasks like image interpretation. The device being described (Regenalase Laser System) is a surgical laser, not an AI diagnostic or assistive tool for human readers. "Clinical trials were not deemed necessary," and the submission focuses on non-clinical substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The concept of a "standalone algorithm performance" is not applicable to this device. The Regenalase Laser System is a physical medical device (a surgical laser), not an algorithm or software that performs a task independently. The device's performance is inherently tied to its physical output and how it interacts with tissue.
7. The Type of Ground Truth Used:
For the thermal performance evaluation, the "ground truth" was established by direct measurement of thermal damage in the ex vivo tissue samples. For other non-clinical tests, the ground truth was conformance to established engineering and medical device standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility).
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Regenalase Laser System is not an AI/ML device that requires a "training set." Its development and validation are based on engineering principles, physical testing, and comparison to a predicate device.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this type of device.
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