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Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, Gynaecology, ENT and General Surgery.

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

• · Urethral Strictures
• · Bladder Neck Incisions (BNI)
• · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors
• · Ablation of Benign Prostatic Hypertrophy (BPH)
• · Transurethral incision of the prostate (TUIP)
• · Holmium Laser Resection of the Prostrate (HoLRP)
• · Holmium Laser Enucleation of the Prostate (HoLEP)
• · Holmium laser Ablation of the Prostate (HoLAP)
• · Condylomas
• · Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate,

• monohydrate and calcium oxalate
• · Dehydrate stones
• · Endoscopic fragmentation of kidney calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

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

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

Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

• · Ligament and tendon Release
• · Contouring and sculpting of articular surfaces
• · Capsulectomy in the Knee
• · Chondreplasty in the Knee
• Debridement of inflamed synovial tissue
• Chondromalacia Ablation
• · Chondromalacia and tears
• Plica Removal
• · Meniscectomy
• Loose Body Debridement
• Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

• · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty
• · Percutaneous Cervical Disc Decompression/Discectomy
• · Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, and haemostasis of soft tissue and cartilage) including:

• · Endonasal/sinus Surgery
• · Partial turbinectomy
• · Polypectomy
• Dacryocystorhinostomy
• · Frontal Sinusotomy
• · Ethmoidectomy
• Maxillary antrostomy
• Functional endoscopic sinus surgery

General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Skin incision
• · Excision of external and internal lesions
• · Complete or partial resection of internal organs, tumors and lesions
• • Biopsy

Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively.

Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).

The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called "special effects": Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations.

Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.

Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be "caught" to be fragmentated. The set energy is the sum of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 μs vs 1100 μs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos.

The device can be divided into four main sections:

• . Power electronics: they manage power supplied to all device compartments;
• . Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
• Cooling system: it cools the laser source pumping chamber;
• . Optical bench.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving device performance.

It's important to note that the provided text is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical laser device. This type of document primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than outlining a detailed clinical or performance study with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, many of the typical questions asked about acceptance criteria and proving device performance for AI/ML devices (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies) are not directly applicable or explicitly detailed in this type of submission.

The "performance" described here is primarily in terms of technical specifications and demonstrating that the device's optical and safety characteristics are similar to or within acceptable limits compared to predicates.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The submission describes the "Litho 60; Litho 100; Litho 150" laser systems. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Litho 60, Litho 100 (K192600), Litho 150 (K201455)) and a reference device (MultiPulse HoPlus (K161257)). The change addressed in this submission is the introduction of a new "Magneto" configuration, which alters the pulse duration.

The "acceptance criteria" in this context are not performance metrics for an AI/ML algorithm (like sensitivity/specificity), but rather the demonstration that the modified device's technical specifications (e.g., laser wavelength, power, pulse width) and safety profiles remain substantially equivalent to, or are a sub-set of, the predicate/reference devices, and that it continues to meet relevant medical device safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document does not describe a "test set" in the context of an AI/ML model's performance on patient data.
• The "testing" mentioned refers to non-clinical bench testing to confirm the device's technical specifications and compliance with safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety).
• Data provenance for such bench tests is typically internal laboratory data, not patient data from specific countries or retrospective/prospective studies.

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

• Not applicable. There is no "ground truth" derived from expert review in this type of submission. Performance is measured against engineering specifications and international standards.

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

• Not applicable. No expert adjudication process foreseen for this type of device and submission.

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/ML device, and no MRMC study was performed.

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 in the AI/ML sense. The "ground truth" here is the adherence to engineering specifications, validated physical measurements (e.g., laser power, pulse width), and compliance with the requirements of recognized safety and performance standards (e.g., IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary, this 510(k) demonstrates substantial equivalence for a medical laser device based on engineering specifications, compliance with international safety standards, and comparison of its performance characteristics (like laser parameters) and indications for use to previously cleared devices. It does not involve AI/ML performance testing or studies with human readers/cases.

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The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

The Sentient Manufacturing Laser Fiber System is a fiber optic delivery device, with the intended use of delivering laser radiation to soft tissue via contact and non-contact procedures, with any compatible laser system. The Sentient Manufacturing Laser Fibers consist of a fiber optic core, cladding, coating, laser specific compatible connector (proximal end), and optional tip configurations on the distal end (sometimes left bare). The device length can vary from 3 - 5 meters in length with core diameter sizes of 200, 400, 605, 800 and 1000 microns. The device also includes a fiber stripper, fiber cleaver, canula and hand piece to prepare and use the fibers in specific procedures. The proximal end of the fiber optic is connected to the laser system via SMA-905 or compatible connector type. This connection between the fiber and the laser system allows for the laser radiation to transmit through the fiber core and output at the distal end of the fiber optic. The fiber connector also keeps the laser centered on the fiber optic surface to ensure proper power transmission throughout the fiber optic. The fiber optic itself is multilayer; comprised of a core, cladding, and a coating. The fiber cladding and coating provide a protective laver around the core. They also have a low refractive index to keep the power confined inside of the fiber core. The distal end of the laser fiber can have multiple configurations to fit the needs of the treatment application. The most common configuration of the distal end is primarily a bare fiber, with a polished surface.

The provided text describes a 510(k) premarket notification for the Sentient Manufacturing Laser Fiber System, aiming to demonstrate its substantial equivalence to a predicate device (K200234 Quanta System Surgical Laser Fibers). This type of submission relies on comparative data rather than a detailed clinical effectiveness study with human subjects, making some of the requested information (like MRMC studies, human reader improvement, and extensive expert ground truthing) not directly applicable or reported in this document.

The acceptance criteria in this context are primarily based on demonstrating a comparable performance to the predicate device across several non-clinical parameters.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): For the performance tests:
  • Power Stability: 10 individual power stability tests were performed on the Sentient Manufacturing Laser Fibers and 10 on the Predicate Device. After sterilization, the power test was re-run 10 times.
  • Tensile Strength: Each fiber (Sentient and Predicate) was tested, implying at least one sample of each, likely more for robust data, but specific number not stated beyond "Each fiber".
  • Beam Profile: At least one sample of each (Sentient and Predicate) was analyzed.
  • Durability (Heat & Sterilization): "Both fibers" (Sentient and Predicate) were subjected to heat testing. "Each fiber optic assembly" for sterilization duration, implying at least one of each type.
• Data Provenance: The tests described are "Internal Performance Testing," meaning they were conducted by the manufacturer, Sentient Manufacturing LLC. The origin (country/location) of the testing facility is not specified, but the company is based in Park City, UT, USA. The data is prospective in the sense that these specific tests were conducted to demonstrate equivalence for this submission, rather than being collected from prior clinical use.

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

This type of 510(k) submission for a laser fiber system does not typically involve expert clinical reads or establishment of ground truth by clinicians. The "ground truth" for the performance tests mentioned (power output, stability, tensile strength, beam profile, durability) is established by physical measurements and comparisons against a well-characterized predicate device. There is no mention of external experts or their qualifications in establishing the "ground truth" for these engineering and performance tests.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical findings or diagnostic outputs from multiple readers. The performance data is objective (e.g., power measurements, physical characteristics, visual comparison of beam profile by technical personnel).

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-assisted diagnostic device and therefore an MRMC study with human readers is not relevant to this submission.

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

Not applicable. This is a physical medical device (laser fiber system), not a software algorithm. The "standalone performance" refers to the device's inherent physical and optical characteristics as measured in the performance tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Physical and Optical Measurements: For power output, power stability, tensile strength, and beam profile.
• Comparative Performance to a Legally Marketed Predicate Device: The primary "ground truth" for substantial equivalence is the demonstrated "nearly identical" or "very similar" performance compared to the K200234 Quanta System Surgical Laser Fibers. This type of submission relies on the predicate having already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI or machine learning algorithm. There is no "training set."

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

Not applicable for the reason above.

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The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The DEKA Smartperio device consists of: An AC/DC power supply unit CPU controller LASER source Cooling system User interface with LCD touch screen Beam delivery system Laser activation is controlled by footswitch.

The provided document is a 510(k) summary for the DEKA SmartPerio laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, noting where information is absent.

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

This document does not specify quantitative acceptance criteria typically seen in performance studies for new medical devices, nor does it report specific device performance metrics in detail beyond a comparison of technical specifications with a predicate device.

Instead, the document's primary "acceptance criteria" appear to be meeting electrical safety and electromagnetic compliance standards, as well as demonstrating substantial equivalence to a legally marketed predicate device.

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

The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to compliance with electrical and laser safety standards. This implies there was no "test set" of patient data in the sense of a clinical trial or performance study. The data provenance and sample size for such a test set are therefore not applicable or not provided.

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, as no clinical test set or ground truth adjudication using experts is mentioned.

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

Not applicable, as no clinical test set or ground truth adjudication is mentioned.

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 DEKA SmartPerio is a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. The DEKA SmartPerio is a physical medical device (laser surgical instrument), not an algorithm or AI system.

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

Not applicable, as no clinical performance study requiring a "ground truth" (e.g., for diagnostic accuracy) was performed or reported.

8. The sample size for the training set

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm.

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