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The Indigo 830e LaserOptic ™ Treatment System is intended to be used in the contact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), and in the contact or non-contact mode for cutting, excision, incision, and coagulation of soft tissue in both open or closed surgical procedures.

The Índigo 830e LaserOptic™ Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

Device Description

The Índigo Diffuser- Tip™ Fiberoptic is a sterile, single-use, disposable fiberoptic which is 3 meters in length with a light-diffusing section at the distal tip. The device is designed to deliver energy from the Indigo Model 830e diode laser only and bears a unique connector for coupling to the 830e laser at the proximal end. Modifications have been made to increase the resistance to breakage of the fiberoptic and improve the manufacturability of the device. None of the changes affect the function, intended use, or overall design of the fiberoptic or of the Indigo LaserOpticTM Treatment System.

AI/ML Overview

The Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option is a modified device, and its acceptance criteria and performance are established through equivalence testing against a previously cleared predicate device (K963969). The study focuses on demonstrating that the modified device performs equivalently to the predicate and shows improved resistance to breakage.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Equivalence to Predicate Device)	Reported Device Performance (Modified Diffuser-Tip™ Fiberoptic)
Equivalent Tissue Temperature Profile	Achieved
Equivalent Lesion Size	Achieved
Equivalent Internal Heating of the Fiber	Assumed equivalent based on other parameters
Equivalent Time to Reach Operating Temperature	Assumed equivalent based on other parameters
Equivalent Fiber Intensity Profile	Assumed equivalent based on other parameters
Equivalent Total Energy Delivered	Assumed equivalent based on other parameters
Improved Resistance to Breakage	Achieved (Significant improvement reported)

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for the nonclinical tests. The tests were performed to compare the modified fiberoptic with the existing fiberoptic for equivalence. The data provenance is a non-clinical "testing" that was performed, implying laboratory or experimental settings rather than patient data. No country of origin for this data is specified, but it's part of a US FDA submission. The study is prospective in the sense of comparing a new modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device's performance is based on direct physical measurements and comparisons to a predicate device, not expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. The testing involves direct physical measurements and comparisons, not subjective interpretations requiring adjudication.

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. This is not a diagnostic device involving human readers or AI.

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

Not applicable. This is a medical device (fiberoptic) for surgical procedures, not an algorithm.

7. The type of ground truth used

The ground truth used is based on direct physical measurements and comparisons to a legally marketed predicate device. This includes:

Tissue temperature profiles
Lesion size
Internal heating of the fiber
Time to reach operating temperature
Fiber intensity profile
Total energy delivered
Resistance to breakage

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a diagnostic tool that learns from data.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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