(28 days)
The Empower H35 laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.
The Empower H35 laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue. The device is a modified version of the legally marketed device Litho (K163009) and is based on Holmium laser sources.
The FDA 510(k) summary for the Empower H35 laser system (K180426) describes a Special 510(k) submission for device modifications to an already cleared device, Litho (K163009). Therefore, the information provided focuses on demonstrating that the modified device remains substantially equivalent to the predicate, rather than an independent clinical study to establish new acceptance criteria.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define specific performance acceptance criteria in numerical terms (e.g., "accuracy must be >90%"). Instead, it states that the device was subjected to performance testing in accordance with recognized consensus standards and that it passed all required testing.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2012 (Basic Safety & Essential Performance) | Passed all required testing |
| Compliance with IEC 60601-1-2:2014 (Electromagnetic Compatibility) | Passed all required testing |
| Compliance with IEC 60601-2-22:2012 (Surgical Laser Equipment Specific Requirements) | Passed all required testing |
| Compliance with IEC 60825-1:2014 (Safety of Laser Products) | Passed all required testing |
| Compliance with FDA Software Verification and Validation Guidance | Conducted and documentation provided, passed |
2. Sample size used for the test set and the data provenance
The document describes performance testing rather than clinical or diagnostic test set evaluations. The "test set" here refers to the device itself being tested according to engineering and safety standards. Therefore:
- Sample size for test set: N/A (The "sample" is the device prototype undergoing testing).
- Data provenance: N/A (The testing is against engineering and safety standards, not a patient dataset). The document implies testing was performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to the type of testing described. Ground truth in this context would refer to objective measurements of physical properties and safety parameters according to the defined standards, typically performed by engineers and technicians using calibrated equipment, not medical "experts" establishing a clinical diagnosis.
4. Adjudication method for the test set
Not applicable. This type of testing involves direct measurement and verification against standard requirements, not interpretation by multiple independent parties.
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
Not applicable. The Empower H35 is a laser surgical instrument, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or mentioned in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is a laser surgical instrument, not an algorithm. The "performance" described is the physical and electrical safety and functionality of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of the Empower H35 is the compliance with established recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and safety/engineering requirements (e.g., software verification and validation guidance). This involves objective measurements of power output, electrical safety, electromagnetic compatibility, laser safety, and software functionality according to predetermined specifications.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
In summary, the provided document describes a Special 510(k) for a medical device modification, where the "study" proving acceptance criteria is a series of engineering and safety tests demonstrating compliance with recognized consensus standards. It is not a clinical study involving human subjects, diagnostic accuracy, or AI performance.
§ 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.