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Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty

The SOLX 790 Titanium Sapphire system is a flashlamp-pumped laser intended for use in performing laser trabeculoplasty. The laser operates at a wavelength of 790 nanometers (nm), and delivers user-selectable pulse energies of 30-80 millijoules (mJ), with nominal pulse duration of 8 microseconds (7+2usec) and a nominal spot size of 200 microns (um). A footswitch activates the laser to deliver pulses of laser energy through an optical fiber to a slit lamp. A trained physician then directs the laser pulses exiting the slit lamp to the desired regions of the trabecular meshwork inside the eye using a Goldman goniolens. A low power, visible aiming beam allows the physician to direct the treatment laser pulses.

The SOLX 790 Titanium Sapphire Laser is a medical device intended for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty. The device's performance was assessed through preclinical and clinical investigations to demonstrate substantial equivalence to a legally marketed predicate device, the COHERENT (LUMENIS) Ultima 2000 Argon Laser (K913127).

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the SOLX 790 Titanium Sapphire Laser are based on demonstrating substantial equivalence to the predicate device, K913127, in terms of intended use, safety, and effectiveness. The table below compares the key features and performance parameters of the SOLX 790 with the predicate device. The "Reported Device Performance" column reflects the specifications of the SOLX 790, which are deemed acceptable by showing equivalence or demonstrating that differences do not raise new questions of safety or effectiveness.

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states that "Preclinical and clinical data was provided to demonstrate that the Titanium Sapphire is safe and effective for use in trabeculoplasty to reduce intraocular pressure in patients with poorly controlled or elevated intraocular pressure or prior failed laser trabeculoplasty." The overarching study design is one of demonstrating substantial equivalence to the predicate device.

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

The document does not explicitly state the sample size for the test set of the clinical investigation, nor does it specify the country of origin of the data or whether the study was retrospective or prospective. It only broadly refers to "clinical investigations."

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical investigation mentioned.

4. Adjudication Method:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth within the clinical investigation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The provided information does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The comparison is primarily between the new device's specifications and the predicate device's specifications, along with general statements about clinical data demonstrating safety and efficacy without a direct human reader comparison in the context of AI.

6. Standalone (Algorithm Only) Performance Study:

This device is a physical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The performance is of the laser system itself, operated by a physician.

7. Type of Ground Truth Used:

The ground truth for demonstrating the safety and effectiveness of the SOLX 790 Titanium Sapphire Laser would be based on clinical outcomes data related to intraocular pressure reduction and safety profiles in patients undergoing laser trabeculoplasty. This means the actual physiological changes and patient responses observed in the clinical investigation.

8. Sample Size for the Training Set:

This device is a hardware system, not an AI algorithm that requires a "training set" in the conventional machine learning sense. Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established:

As explained above, the concept of a "training set" and associated ground truth establishment is not relevant to this type of medical device submission.

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