FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely;

Laser Endoprobes .
Laser Indirect Ophthalmoscope .
Slitlamp Delivery Systems .
The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

AI/ML Overview

The provided text is a 510(k) summary for the Laserex Model LP1532, a solid-state laser photocoagulator. This documentation is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a traditional scientific study would.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance simply does not exist within this document.

The document primarily focuses on technical specifications, intended uses, and a comparison to predicate devices to establish substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't define specific "acceptance criteria" for clinical performance in the way a clinical study would. Instead, its acceptance criteria for clearance are based on demonstrating substantial equivalence to predicate devices. The "performance" reported is primarily the device's technical specifications and a direct comparison to those of the predicate devices.

Characteristic Compared	Predicate Devices (Range/Typical)	Laserex LP1532 Performance	Acceptance Status (vs. Predicate)
Intended Uses	Range of ophthalmic treatments (Retinal Photocoagulation, Pan Retinal Photocoagulation, Endophotocoagulation, Photocoagulation for Macular Degeneration, Laser Trabeculoplasty)	Same intended uses as predicate devices.	Equivalent
Laser Power (W)	1.2W - 3W	Up to 2W	Falls within or near the range of predicates; considered equivalent for intended use.
Laser Wavelength (nm)	532nm	532nm	Equivalent
Laser Class	IV	IV	Equivalent
Exposure Time (sec)	0.01 - 3 sec (some and CW)	0.01 to 2.0 sec	Within the typical range of predicates.
Aiming Laser Type	HeNe, Red Diode	Red Diode	Similar to some predicates.
Aiming Laser Power	0 - 1 mW	0.05 to 0.95 mW	Within the range of predicates.
Aiming Wavelength	630 - 670 nm	635nm	Within the range of predicates.
Electrical Supply	Various AC configurations	100-250VAC, 50/60 Hz	Standard electrical specs, comparable.
Power Consumption	300W - 3KW	450W	Falls within the range of predicates, specifically more efficient than some (e.g., Alcon Ophthalas 532).
Weight	8.1Kg - 99 Kg	17 Kg	Falls within the range of predicates.
Size	Various dimensions	W 31cm, D 51cm, H 19cm	Falls within the range of predicates.
Cooling	Air cooled, Internal water cooling	Air cooled	Similar to some predicates (Iris Occulite, Alcon EyeLyte).
Scientific Concepts	Green laser source, Yag laser, Diode/Arclamp pumping, fiberoptic delivery	Green laser source, Diode pumped Yag, air cooling, software control, fiberoptic delivery	Similar underlying technology principles to predicate devices.
Accessories	Endo Probes, LIO, Slitlamp Adaptors, Operating Microscope Filters	Equivalent range of accessories available and adaptable to common clinical equipment.	Equivalent
Spot Size	50-1000 microns	50-500 microns	Within the range of predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This document does not describe a clinical study with a test set of patients or medical images. It's a technical submission for regulatory clearance based on substantial equivalence.
Data Provenance: Not applicable for clinical performance data. The "data" provided is primarily technical specifications and comparative analysis against existing, legally marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. No clinical ground truth establishment process is described in this document.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

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

MRMC Study: No, this document does not mention or present any MRMC comparative effectiveness study. The device is a laser photocoagulator, not an AI-assisted diagnostic or therapeutic system that would typically be evaluated in such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. The device is a medical device (laser system) operated by a physician, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: Not applicable for clinical performance. The "ground truth" for the 510(k) submission is the established safety and effectiveness of its predicate devices. The new device demonstrates "substantial equivalence" to these predicates.

8. The Sample Size for the Training Set

Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device being developed through data training.

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment: Not applicable. No training set is mentioned.

Summary of Device Evidence for Substantial Equivalence (from the document):

The primary "study" proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is a comparison of its technical specifications and intended uses to those of legally marketed predicate devices.

"Study" Methodology: A table-based comparison (Sections 5.4 and 7) of the Laserex LP1532's characteristics (e.g., laser power, wavelength, accessories, physical dimensions, electrical requirements, scientific concepts) against four predicate devices: Alcon Ophthalas 532, Alcon EyeLite, Iris Occulite, and Nidek Prima.
Key Findings: The document asserts, "There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product." The detailed comparative tables support this by showing that the LP1532's specifications fall within the range or are similar to those of the predicate devices.
Biocompatibility and Sterilization: For patient-contacting components (endo probes), the submission relies on the 510(k) approvals of the supplier (Creative Medical Products, Inc.) for those specific probes (K954307, K954308).
Software Validation: The document notes that software validation and verification processes are ongoing but believes equivalence can be determined before completion, with a commitment from the CEO to complete these processes (Section 9). The level of concern for the software was identified as "Minor to Moderate."

This 510(k) summary provides evidence of technical and functional equivalence to existing devices, which is the basis for regulatory clearance in the absence of new safety or efficacy questions. It is not designed to present de novo clinical performance data in the format of a research study.

Summary

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.