(29 days)
The Multicavity Holmium 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 subject device is derived from the legally marketed (unmodified) device Litho 60 (K172025). This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power and frequency.
This document describes the FDA clearance (K180922) for the Quanta System SPA's Holmium laser systems (Empower H100, Cyber Ho 100, Litho 100). However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance related to diagnostic accuracy, or human reader performance with or without AI assistance.
The submission is specifically a Special 510(k) for "Device modifications" to an already cleared device (Litho 60, K172025). This type of submission generally relies on demonstrating that the modified device remains substantially equivalent to the predicate device, primarily through engineering, performance, safety, and software testing, rather than new clinical efficacy studies.
Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria and reported device performance related to clinical outcomes.
- Sample sizes for test sets where clinical performance (e.g., diagnostic accuracy) would be evaluated.
- Number of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies or effect sizes of human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used for clinical performance.
- Training set sample size or ground truth establishment for a training set (as this is not an AI/ML device where such details would be relevant to the submission type).
Based on the provided text, the acceptance criteria and study proving the device meets them are focused on engineering performance, safety, and software validation.
Here's what can be extracted from the document regarding acceptance criteria and performance testing for these modifications:
1. Acceptance Criteria and Reported Device Performance (as per a Special 510(k) for device modifications):
| Acceptance Criteria Category | Details (as per device modifications) | Reported Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2012, ed 3.1; IEC 60601-2-22: 2012-10 ed 3.1. | "The subject device passed all the required testing and applicable sections of the above-mentioned performance standards." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4: 2014. | "The subject device passed all the required testing and applicable sections of the above-mentioned performance standards." |
| Laser Safety | Compliance with IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements. | "The subject device passed all the required testing and applicable sections of the above-mentioned performance standards." |
| General Performance | Not explicitly detailed but implied by "performance testing" to ensure the broadening of laser emission parameters (power and frequency) works as intended. | "The subject device passed all the required testing and applicable sections of the above-mentioned performance standards." |
| Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." |
| Intended Use/Indications for Use Preservation | The modified device must maintain the same intended use as the unmodified predicate device. | "The modified device has the same intended use of the unmodified device." "Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications." |
| Fundamental Scientific Technology Preservation | The device must continue to be based on Holmium laser sources. | "The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Holmium laser sources." |
2. Sample Size and Data Provenance:
This document indicates that the tests conducted were primarily engineering/bench testing and software verification/validation. These types of tests do not typically use "patient data" or "test sets" in the context of clinical performance evaluation. The data provenance would be laboratory results from the manufacturer.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable for this type of submission. Ground truth for engineering tests is based on established scientific principles, physical measurements, and standard compliance.
4. Adjudication Method for Test Set:
Not applicable. These are objective engineering and software tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention any clinical studies, MRMC studies, or AI assistance for human readers. This is a laser surgical instrument, and the modifications are related to its hardware, software, and emission parameters, not an AI diagnostic component.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (laser), not a standalone algorithm.
7. Type of Ground Truth Used:
For the various tests conducted (electrical safety, EMC, laser safety, software), the "ground truth" is adherence to recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1) and internal design specifications, verified through objective measurements and checks.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
In summary, the provided FDA clearance letter and summary for K180922 focuses on demonstrating substantial equivalence through non-clinical testing for hardware and software modifications to an existing device, rather than new clinical efficacy studies or performance evaluation of an AI-driven system.
§ 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.