(195 days)
The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.
The DEKA BLUEBEAM is a diode laser engineered to enhance performance in surgical applications. The DEKA BLUEBEAM electrical specifications are: 100-230V~, 50/60Hz, 300VA.
The FDA 510(k) Clearance Letter for the DEKA BLUEBEAM laser device explicitly states that no clinical performance data was submitted or used for its clearance. The clearance was based solely on non-clinical performance data and a comparison to a predicate device.
Therefore, the following information cannot be provided based on the given document:
- A table of acceptance criteria and the reported device performance: This document does not contain specific acceptance criteria or performance metrics derived from clinical (human) studies. The assessment was based on equivalence to a predicate device and adherence to safety and electromagnetic compatibility standards.
- Sample size used for the test set and the data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is a laser surgical instrument, not an AI-assisted diagnostic device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser surgical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for non-clinical testing refers to the specifications and performance against established safety and technical standards (e.g., electrical safety, EMC, laser safety).
- The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set in the context of clinical performance.
- How the ground truth for the training set was established: Not applicable.
However, I can provide information on the non-clinical acceptance criteria and the study that proves the device meets these criteria, based on the provided document:
Non-Clinical Acceptance Criteria and Study Details:
The DEKA BLUEBEAM device clearance was based on its substantial equivalence to a predicate device (Wolf 445nm, K192272) and its compliance with relevant non-clinical performance and safety standards.
1. Non-Clinical Acceptance Criteria and Reported Performance:
The primary acceptance criterion was demonstrating that the DEKA BLUEBEAM is "as safe, as effective, and performs as well as the legally marketed predicate device (K1992272)." This was assessed through:
- Comparison of Technical Specifications: Demonstrating close similarity or subset relationship of key laser parameters to the predicate.
- Compliance with Recognized Standards: Meeting specific electrical safety, electromagnetic compatibility (EMC), and laser safety standards.
- Software Verification and Validation: Ensuring the software functions as intended and is safe.
| Acceptance Criteria (Implicit via Predicate Equivalence & Standards Compliance) | Reported DEKA BLUEBEAM Performance/Characteristics |
|---|---|
| Indications for Use (Identical to Predicate) | Intended for incision, excision, vaporization, ablation, hemostasis, and coagulation of body soft tissue. |
| Regulation Number (Identical to Predicate) | 21 CFR 878.4810 |
| Product Code (Identical to Predicate) | GEX |
| Laser Type (Identical to Predicate) | Diode Laser |
| Laser Power (Identical to Predicate) | From 0.5W to 10W |
| Wavelength (Identical to Predicate) | 445nm |
| Laser Class (Identical to Predicate) | Class 4 |
| Operation Mode (Similar/Subset to Predicate) | Continuous Wave (CW), Pulsed mode (PW) or Single Pulse |
| Pulse Length / Duration (Subset of Predicate) | 1 ms to 2 s |
| Pulse Frequency (Subset of Predicate) | 0.25 to 500 Hz and Single Pulse |
| Spot Size (Similar to Predicate) | 0.27 to 0.6 mm |
| Aiming Beam Wavelength (Similar to Predicate) | 520 nm |
| Aiming Beam Power (Subset of Predicate) | 3.2 mW |
| Use in Combination (Identical to Predicate) | Optical fibers with or without handpieces |
| Cooling (Identical to Predicate) | Air |
| Electrical Safety Compliance | Compliant with ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 and IEC 60601-2-22:2019. |
| Electromagnetic Compatibility (EMC) Compliance | Compliant with IEC 60601-1-2 Edition 4.1 2020-09. |
| Laser Safety Compliance | Compliant with IEC 60825-1: 2014. |
| Software Verification & Validation Compliance | Conducted and documented as recommended by FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the non-clinical testing, the "sample size" refers to the specific DEKA BLUEBEAM device(s) subjected to the electrical safety, EMC, and laser safety tests, and the software itself for V&V. The document does not specify the exact number of physical units tested, but it implies a sufficient number were tested to demonstrate compliance.
- Data Provenance: The testing was conducted by or for El.En. S.p.A. based in Italy. The data is generated from laboratory testing of the device itself against international and national standards. This is prospective testing specifically for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
- Number of Experts/Qualifications: This is not applicable in the sense of human interpretation of medical images or data. The "ground truth" for non-clinical testing is established by the definitions and requirements of the referenced international and national standards (e.g., IEC 60601 series, IEC 60825 series). The experts involved would be certified testing engineers and regulatory affairs professionals who interpret and apply these standards.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Non-clinical compliance is typically a pass/fail determination against pre-defined limits or requirements set by the standards, not a consensus or adjudicated reading process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret outputs (e.g., medical images) with and without AI assistance. The DEKA BLUEBEAM is a laser surgical instrument.
6. Standalone Performance (Algorithm Only):
- Standalone Performance: Not applicable. This refers to the performance of a software algorithm without human interaction, typically in diagnostic or analytical AI. The DEKA BLUEBEAM is a medical device incorporating software, but its primary function is physical intervention (laser surgery), not analytical output. Its "performance" is assessed overall as a system meeting safety and functional specifications.
7. Type of Ground Truth Used:
- Ground Truth: For non-clinical performance, the "ground truth" is defined by the internationally recognized performance and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the technical specifications of the predicate device. The device's performance (e.g., output power, wavelength, electrical safety parameters, EMC emissions/immunity) is measured directly and compared against the specific limits and requirements set forth in these standards and the predicate's known performance.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. The DEKA BLUEBEAM is not an AI/machine learning device in the context of requiring training data to learn diagnostic or predictive patterns. Its software is for controlling the hardware and ensuring safe operation, verified through traditional software validation methods.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the machine learning sense for this device. Software verification and validation involve testing the software against its functional and non-functional requirements, which serve as the "ground truth" for whether the software performs as designed and safely.
§ 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.