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Fiber Dust PRO is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• · Laser Resection of the Prostrate (LRP)
• · Laser Enucleation of the Prostate (LEP)
• · Laser Ablation of the Prostate (LAP)
• · Transurethral Incision of the Prostate (TUIP)
• Condylomas
• · Urethral strictures
• Lesions of external genitalia
• · Bladder neck incisions (BNI)
• · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• · Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
• monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Angiodysplasia
• · Polyps
• · Colorectal cancer
• · Biopsy
• · Telangiectasias
• Gall Bladder calculi
• · Telangiectasias of the Osler-Weber-Renu disease
• Biliary/Bile duct calculi
• Vascular Malformation
• Ulcers
• · Gastritis
• · Gastric ulcers
• · Esophagitis
• · Duodenal ulcers
• · Esophageal ulcers
• Non Bleeding Ulcers
• · Varices
• Pancreatitis
• Colitis
• Haemorrhoids
• Mallory-Weiss tear
• ·Cholecystectomy
• · Gastric Erosions
• ·Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Fiber Dust PRO is a laser system that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 um. The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical format of a clinical trial or performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, this is a 510(k) summary for the device "Fiber Dust PRO," indicating it's a premarket notification to the FDA. The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device (FiberDust - Quanta System S.p.A. (K210142)).

Here's a breakdown of the information available, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or other quantitative measures typically associated with device performance in clinical studies for diagnostic or AI-driven devices.

Instead, the "Performance data" section (page 7) states:

• "Based on the nature of the modified device was subjected to performance testing in accordance with the following recognized consensus standards:
  • IEC 60601-1:2005 MOD Medical Electrical equipment Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests"
• "The modified device passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

This indicates that the "acceptance criteria" were compliance with these safety and performance standards for medical electrical equipment, which the device reportedly met. These standards typically cover aspects like electrical safety, electromagnetic compatibility, mechanical safety, and basic operational performance, not clinical efficacy or diagnostic accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on compliance with engineering standards and comparison to a predicate device, not on a clinical trial with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth established by experts is described for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 an AI-driven or diagnostic device undergoing an MRMC study.

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

Not applicable. This is a laser surgical instrument, not an algorithm.

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

Not applicable. The performance reported is adherence to electrical and electromagnetic compatibility standards, not clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of the Study and Device Claim:

The "study" presented here is a premarket notification (510(k)) aimed at demonstrating substantial equivalence to a previously cleared predicate device (FiberDust, K210142). The Fiber Dust PRO is a powered laser surgical instrument.

The key aspects of the "study" are:

• Device Comparison: The Fiber Dust PRO is described as a modified version of the predicate device, primarily differing in its configuration (mobile vs. desktop). Key technical specifications (laser source, wavelength, emission, pulse duration, frequency, max average power, delivery system, aiming beam) are stated to be "Same or similar" to the predicate.
• Intended Use: The intended use and indications for use are "exactly the same" as the predicate device.
• Performance Data: The device underwent testing to ensure compliance with recognized international safety and performance standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that the device "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."
• Software Verification and Validation: Software testing was conducted according to FDA guidance for medical device software.
• Biocompatibility: No new patient-contacting materials were introduced that would adversely affect biocompatibility, implying reliance on the predicate's biocompatibility assessment.
• Conclusion: The submission concludes that the modifications "do not raise new types of questions regarding the safety and effectiveness" and that the performance testing supports its safe and effective use, thus establishing substantial equivalence to the predicate.

In essence, the "acceptance criteria" here are compliance with established safety and general performance standards for medical devices and demonstration that the changes from the predicate do not alter its safety or effectiveness profile. This is typical for a 510(k) submission for a non-diagnostic, non-AI device where engineering and safety standards are the primary focus of performance evaluation, rather than clinical efficacy studies with patient data.

Ask a specific question about this device

Fiber Dust is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• · Laser Resection of the Prostrate (LRP)
• · Laser Enucleation of the Prostate (LEP)
• · Laser Ablation of the Prostate (LAP)
• · Transurethral Incision of the Prostate (TUIP)
• Condylomas
• · Urethral strictures
• Lesions of external genitalia
• · Bladder neck incisions (BNI)
• · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• · Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
• monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Angiodysplasia
• · Polyps
• · Colorectal cancer
• · Biopsy
• · Telangiectasias
• Gall Bladder calculi
• · Telangiectasias of the Osler-Weber-Renu disease
• Biliary/Bile duct calculi
• Vascular Malformation
• Ulcers
• · Gastritis
• · Gastric ulcers
• · Esophagitis
• · Duodenal ulcers
• · Esophageal ulcers
• Non Bleeding Ulcers
• · Varices
• Pancreatitis
• Colitis
• Haemorrhoids
• Mallory-Weiss tear
• ·Cholecystectomy
• · Gastric Erosions
• ·Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue.

The Fiber Dust laser device includes a diode laser that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 μm.

The main subsystems of the device are the diode laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

The provided text is a 510(k) summary for the "Fiber Dust" laser device, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing against recognized consensus standards. It does not contain information about the use of AI/ML or a study that establishes acceptance criteria for an AI-powered device's performance metrics like sensitivity, specificity, or AUC, as typically seen in submissions for AI/ML medical devices.

Therefore, the requested information cannot be fully extracted based on the provided text. Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided in a format relevant to AI/ML device performance (e.g., no metrics like sensitivity, specificity, or accuracy based on a clinical ground truth). The document states that "non-clinical performance standards testing support that the device can be used safely and effectively," but these refer to engineering and safety standards, not AI performance metrics.

2. Sample size used for the test set and the data provenance: Not applicable, as no AI/ML test set is described. Performance testing primarily refers to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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. The device is a surgical laser, not an AI-assisted diagnostic or decision-support tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the purposes of this submission, the ground truth relates to the device meeting engineering and safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety). There is no "ground truth" as it would be defined for an AI/ML diagnostic or predictive model.

8. The sample size for the training set: Not applicable, as there is no mention of an AI model being trained.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The acceptance criteria for the Fiber Dust device are based on compliance with recognized consensus standards for medical electrical equipment and laser safety.

• IEC 60601-1:2012, ed 3.1 (General Requirements for Basic Safety And Essential Performance)
• IEC 60601-1-2:2014, ed 4 (Electromagnetic Disturbances - Requirements And Tests)
• IEC 60601-2-22: 2012, ed 3.1 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
• IEC 60825-1:2014, ed 3.0 (Safety of laser products – Part 1: Equipment classification and requirements)
• IEC60601-1-6:2013, ed 3.1 (Usability)

Additionally, "Software Verification and Validation Testing" was conducted following FDA guidance for software in medical devices.

The "study" or testing that proves the device meets these criteria refers to the performance testing against these standards, the results of which "support that the device can be used safely and effectively." These are non-clinical tests typically conducted in a laboratory or engineering environment. The document states: "The results of the non-clinical performance standards testing support that the device can be used safely and effectively."

In conclusion, the provided text describes the clearance of a traditional medical device (a surgical laser) based on engineering and safety standards compliance, not an AI/ML-driven device with performance metrics based on clinical data or expert ground truth.

Ask a specific question about this device