(14 days)
This device will be used in ophthalmic applications, including:
- . Posterior Capsulotomy
- Peripheral Iridotomy .
- Pupillary Membranectomy .
The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has the form of a table containing supply and control electronics and supporting a headrest where the head of the patient is placed, as well as a movable housing that is controlled by a joystick. The housing comprises a biomicroscope with a slit-lamp illumination (Haag-Streit), a Qswitched Nd:YAG laser, a laser diode producing a red (635 nm) aiming beam and optical, mechanical and electronics elements necessary to control the parameters and geometry of the laser beams.
The integrated Q-switched Nd:YAG laser emits short pulses of light at wavelength of 1064 nm. This light is focused in the plane of observation of the ophthalmic microscope. The irradiance at the focal point is high enough to cause optical breakdown, thus permitting the disruption of tissues.
The MICRORUPTOR V allows the physician to adjust the energy delivered to the target tissue and to precisely control and visualize the position of the beam focus, thus allowing a precise and noninvasive dissection of tissues inside the eye of the patient.
This document is for a medical device cleared in 2002, which is before the current requirements for AI/ML device submissions. Therefore, the document does not contain the detailed information typically expected for AI/ML device studies, such as specific acceptance criteria tied to performance metrics, sample sizes for training/test sets, ground truth establishment methods for AI, or comparative effectiveness studies with human readers.
The information provided focuses on demonstrating substantial equivalence to a predicate device, as was the standard practice at that time.
Here's an analysis based on the provided text, highlighting the absence of AI/ML-specific details:
Device: MICRORUPTOR V (Q-switched Nd:YAG laser)
Intended Use: Noninvasive tissue/membrane dissection (photodisruption) in the eye, including posterior capsulotomy, peripheral iridotomy, and pupillary membranotomy.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission from 2002 for a laser device (not an AI/ML device), the "acceptance criteria" are not framed in terms of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, they revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Summary of Submission) |
|---|---|
| Intended Use Equivalence: Same indications for use as the predicate device. | Identical indications: posterior capsulotomy, peripheral iridotomy, pupillary membranotomy. |
| Technological Equivalence: Similar fundamental technology, design, and operating principles. | Both are Q-switched Nd:YAG lasers, emit 1064 nm light, and allow energy adjustment and beam focus control. "Controls, materials, method of manufacture, indications and labeling of both systems are identical or equivalent." |
| Performance Equivalence (Clinical/Functional): Achieves similar clinical outcome/functionality as the predicate. | Expected to achieve similar tissue disruption as the predicate, based on equivalent technology. No AI performance metrics are relevant here. |
| Safety Equivalence: Does not raise new questions of safety or effectiveness. | No new safety concerns identified; design and operating principles are similar to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This device is a laser system, not an AI/ML algorithm that operates on a "test set" of data. The submission relies on engineering specifications and comparison to the predicate device, not on data-driven performance metrics from a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. As above, there is no "test set" in the context of an AI/ML algorithm for which ground truth would be established by experts.
4. Adjudication Method for the Test Set
- Not Applicable. There is no test set or adjudication method described for an AI/ML algorithm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a hardware device, not an AI/ML system. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a standalone medical device (laser system), not a standalone AI/ML algorithm intended to analyze data without human intervention. The device is operated by a "skilled Physician."
7. The Type of Ground Truth Used
- Not Applicable. For this laser device, "ground truth" would relate to its physical properties (e.g., energy output, wavelength, beam focus accuracy) and its ability to achieve tissue disruption safely when operated by a physician. This is established through engineering testing and clinical experience with the predicate device, not through expert consensus, pathology, or outcomes data in the context of an AI's diagnostic or predictive output.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no training set for an AI/ML algorithm.
Summary regarding AI/ML Device Study Information:
The provided 510(k) summary for the MICRORUPTOR V laser system does not contain any of the requested information pertaining to AI/ML device studies because the device itself is a traditional medical hardware device, not an AI/ML-driven diagnostic or therapeutic tool. The clearance is based on demonstrating substantial equivalence to a predicate device, which primarily involves comparing specifications, intended use, and technological characteristics.
§ 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
(a)
Identification. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.(b)
Classification. Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.