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The Holmium Medical Laser and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynecology, ENT, Pulmonary Surgery and General Surgery.

Urology
Open and endoscopic surgery (incision, 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 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, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

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

Pulmonary Surgery
Open and endoscopic pulmonary surgery (cutting, vaporization, incision and coagulation of soft tissue)

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, turnors and lesions
• · Biopsy

The devices belonging to Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. Specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided document is a 510(k) summary for a medical device called "Holmium Medical Laser." It demonstrates substantial equivalence to predicate devices, which means it has similar intended use, technological characteristics, and safety/efficacy profile to devices already legally marketed in the U.S.

However, the document does NOT describe a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or reader performance with and without AI assistance. This type of study is typically done for AI/ML-enabled devices that rely on complex algorithms for diagnosis or analysis, often involving image interpretation.

The Holmium Medical Laser is a surgical instrument, a hardware device that emits laser energy for various surgical procedures. The testing described is primarily focused on safety and performance standards for a physical device, not an AI algorithm.

Therefore, many of the requested details from your prompt, such as "multireader multicase study," "effect size of how much human readers improve with AI," "standalone algorithm performance," "type of ground truth (expert consensus, pathology, outcomes data)," and "training set details," are not applicable to the information provided in this 510(k) summary for a "Holmium Medical Laser."

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, reinterpreted for a physical medical device:

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

For a physical medical device like a laser, "acceptance criteria" and "reported device performance" are typically defined by adherence to recognized electrical, laser safety, and risk management standards. The document states that the device was tested in compliance with these standards.

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

• Sample Size: Not applicable in the context of clinical test sets for AI/ML. The "testing" refers to verification and validation of engineering specifications and compliance with safety standards, not a clinical trial on patient data.
• Data Provenance: Not applicable for device safety and performance testing.

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

• Not applicable. Ground truth as understood in AI/ML (e.g., expert annotations on images) is not relevant for this type of device submission. Safety and performance are established through engineering tests and adherence to established standards.

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

• Not applicable. This refers to consensus methods for expert labeling in AI/ML datasets.

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:

• No. This is a hardware surgical laser, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. The device is a surgical laser, directly operated by a human surgeon. There is no "standalone algorithm" performance to evaluate.

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

• Not applicable in the AI/ML context. The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and functional requirements (e.g., laser output measurements, electrical safety checks).

8. The sample size for the training set:

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

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

• Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (Holmium Medical Laser) and details its substantial equivalence to predicate devices by demonstrating compliance with established safety and performance standards. It does not contain information related to AI/ML device acceptance criteria or studies involving clinical image interpretation, which is what your detailed prompt questions are geared towards.

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The Solvo 35W is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy
• Urology
• Lithotripsy
• Pulmonology
• Gastroenterology
• Gynecology
• ENT
• General Surgery

The Dornier Medilas H Solvo 35 Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400 um (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Solvo can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coaqulation and vaporization.

The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.

A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. There is a wireless remote display panel available as well that allows the user to see the control panel information without being in front of the unit.

The provided document is a 510(k) premarket notification summary for a medical device, the Dornier Medilas H Solvo 35 Laser. It describes the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.

Key takeaway regarding Acceptance Criteria and Study proving device meets criteria:

Based on the provided text, there is no specific clinical study with human patients described that establishes acceptance criteria for performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI-driven device. This document is for a surgical laser, a therapeutic device, and the evaluation for substantial equivalence primarily focuses on engineering specifications, safety standards, and technological characteristics compared to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or not mentioned in this type of submission for this particular device.

Here's how to address your request based on the information available:

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

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 for this type of device and submission. This 510(k) is based on engineering verification and validation testing, compliance with standards, and comparison to a predicate device, not a clinical study on a patient test set to evaluate diagnostic performance. The "performance data" section refers to adherence to voluntary standards and software V&V, not clinical outcomes data from a specific patient cohort.

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

• Not applicable. No clinical ground truth was established by experts for a test set in this submission. The "truth" for this device is its adherence to specified engineering parameters and safety standards, verified through bench testing and documentation.

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

• Not applicable. No test set requiring expert adjudication was conducted.

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 device is a surgical laser, not an AI-driven diagnostic or assistive technology. 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 hardware surgical device, not an algorithm. Benchtop testing and engineering verification ensure its standalone performance against specifications.

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

• The "ground truth" for this submission revolves around engineering specifications, compliance with recognized voluntary standards (e.g., IEC standards for medical electrical equipment and laser safety), and risk management (ISO 14971). For software, software verification and validation serve as the "ground truth" that the software performs as intended. The "truth" is that the device, when manufactured and used correctly, is safe and effective within its specified parameters and is substantially equivalent to the predicate.

8. The sample size for the training set

• Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set for an AI model.

In summary, the provided document is a regulatory submission for a medical device that is a surgical laser. The "acceptance criteria" and "study" described are primarily related to engineering validation, compliance with established safety and performance standards for medical electrical equipment and lasers, and demonstration of substantial equivalence to a legally marketed predicate device. It does not involve typical clinical study designs for diagnostic devices or AI algorithms that would require patient data, expert ground truth, or statistical performance metrics like sensitivity/specificity.

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The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and in Lithotripsy of stones.

It is indicated in medical specialties including, but not limited to:

• . Urology
• Gastroenterology
• Arthroscopy .
• . Neurosurgery
• Pulmonary .
• . Gynecology
• 0 ENT
• Dermatology 0
• Plastic Surgery ●
• General Surgery .

This Special 510(k) of the modified device Cyber Ho is submitted due to Device Modifications of the already cleared device Litho (K163009) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power, energy and frequency.

The provided text is a 510(k) Summary for the Cyber Ho laser system, detailing modifications made to an already cleared device, Litho (K163009). The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria for a diagnostic algorithm, a study proving device meeting acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.

Instead, the document details physical device modifications, regulatory compliance, and performance testing related to electrical safety, electromagnetic compatibility, and laser equipment standards.

Here's an analysis of what is present and what is missing based on your request:

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

• Not provided. The document does not include quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics typically associated with a diagnostic or AI algorithm. It only states that the device "successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards" and "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

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

• Not provided. This information is relevant to studies involving patient data or images, which are not described here. The study here focuses on device engineering performance.

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/Not provided. This information is relevant to clinical studies where expert consensus is used to establish ground truth for a diagnostic algorithm. The document describes engineering and safety testing.

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

• Not applicable/Not provided. This is relevant for clinical studies involving expert readers, which is not the type of study 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:

• Not provided/Not applicable. This document describes a laser surgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to this submission.

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

• Not applicable/Not provided. The device is a surgical laser system, not an algorithm, so "standalone algorithm performance" is not relevant in this context.

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

• Not applicable/Not provided. The "ground truth" in this context refers to compliance with established engineering and safety standards (e.g., electrical safety limits, EMC emission limits).

8. The sample size for the training set:

• Not applicable/Not provided. This pertains to machine learning algorithms, which are not the subject of this 510(k) submission.

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

• Not applicable/Not provided. As above, this relates to machine learning.

Summary of what the document does provide regarding device performance and compliance:

The document describes the Cyber Ho laser system, which is a modification of a previously cleared device, Litho (K163009). The modifications include hardware and software changes, and a broadening of laser emission parameters (power, energy, frequency).

Performance Standards and Compliance (as described):

• No mandatory performance standards specific to this device type were identified, but the device underwent and passed testing according to the following recognized consensus standards:

  • IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
  • IEC 60601-2-22:2007+ A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • IEC 60825-1 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification and requirements

• Reported Device Performance (Qualitative):

  • "The device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards."
  • "The modified device Cyber Ho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

In essence, the study described in this 510(k) summary is an engineering and regulatory compliance study demonstrating that the modified device continues to meet established safety and performance requirements for medical electrical equipment and laser products, rather than a clinical study evaluating diagnostic accuracy or AI performance.

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