(27 days)
The Empower H65 laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.
The Empower H65 laser system and its fiber optic delivery system. The device is a modified version of the Litho 60 (K172025) with some technical modifications.
The provided text is a 510(k) summary for the Empower H65 laser system. It describes the device, its intended use, modifications, and testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain information regarding traditional acceptance criteria, performance metrics, or study details (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies) typically found in an AI/ML medical device submission.
The document states: "There are no mandatory performance standards for this device." and focuses on demonstrating compliance with electrical safety, electromagnetic compatibility, and general laser safety standards. The performance testing section specifically refers to:
- IEC 60601-1:2012, ed 3.1 (Basic Safety And Essential Performance)
- IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Compatibility)
- IEC 60601-2-22: 2012-10 ed 3.1 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
- IEC 60825-1 Ed. 3.0 (2014) (Safety of laser products)
- Software verification and validation testing (as per FDA guidance for software in medical devices)
Since the prompt asks for specific details related to acceptance criteria and study design for demonstrating performance, and the provided document focuses on regulatory compliance and safety standards rather than clinical performance metrics, the answer will reflect the absence of this information in the input.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2012, ed 3.1 | Passed |
| Compliance with IEC 60601-1-2 Edition 4: 2014 | Passed |
| Compliance with IEC 60601-2-22: 2012-10 ed 3.1 | Passed |
| Compliance with IEC 60825-1 Ed. 3.0 (2014) | Passed |
| Software Verification and Validation | Successfully passed, documentation provided as recommended |
2. Sample sized 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 testing described is related to hardware and software performance according to electrical and safety standards, not a clinical test set with patient 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 and not provided. The "ground truth" concept is relevant for AI/ML diagnostic or prognostic devices, which this laser system is not. The testing focused on technical performance against engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not described here.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is relevant for AI-assisted diagnostic tools, not for a surgical laser system designed for direct therapeutic intervention. The device is a surgical instrument, not an AI diagnostic assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the Empower H65 is a laser surgical instrument, a hardware device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The concept of "ground truth" as it applies to clinical data for device performance evaluation is outside the scope of the substantial equivalence claim presented in this 510(k) summary for a surgical laser.
8. The sample size for the training set
This information is not applicable as the Empower H65 is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the Empower H65 is a hardware device, not an AI/ML algorithm that requires a training set and ground truth establishment in that context.
§ 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.