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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The devices belonging to Multicavity 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. A 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) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).

However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.

However, I can extract the available information regarding the device's technical specifications and the standards it met:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions (2-9):

The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.

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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The devices belonging to Multicavity 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. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided text describes a 510(k) premarket notification for a medical device (Quanta System Spa's Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60) which involves a modification to existing cleared devices. The modification is the addition of a new emission mode called "Virtual Basket" based on pulse modulation.

Critically, this document does not contain acceptance criteria or study data that proves the device meets specific performance metrics.

The submission is a Special 510(k) for device modifications, which means it evaluates whether the modified device remains substantially equivalent to its predicate devices, rather than establishing new performance benchmarks through de novo studies. Due to this, the level of detailed performance study data, acceptance criteria, and clinical trial information typically associated with complex AI/ML device submissions is not present.

Here's what can be extracted, and what information is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "Based on the nature of the changes implemented, the device underwent and successfully passed software verifications and validation according to the relevant standards." This implies the "acceptance criteria" were successful completion of these tests. However, no specific numerical or qualitative performance criteria are listed for the "Virtual Basket" mode.

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

• Sample Size: Not applicable in the context of a clinical test set with patients/data. The testing involved bench testing (presumably on materials relevant to laser-tissue interaction or stone fragmentation) and software verification and validation. No patient-specific test set is described.
• Data Provenance: Not applicable. The tests are technical/engineering in nature (bench testing, software V&V) rather than clinical studies using patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. There is no mention of human experts establishing a "ground truth" for a test set, as this submission is not about an AI/ML diagnostic or prognostic device requiring expert annotation. It's about a laser surgical instrument and a new emission mode.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not done. The device is a surgical laser, not an imaging analysis or diagnostic AI/ML device that assists readers. The document only mentions "Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device".

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable in the typical sense of AI/ML. The "Virtual Basket" mode is an emission mode of a laser; it's always used by a human surgeon. The "software verification and validation testing" would assess the software's standalone functionality.

7. The Type of Ground Truth Used:

• For Bench Testing: Likely physical measurements, observations, and objective assessment against engineering specifications related to laser power, pulse characteristics, and effects on target materials (e.g., stone fragmentation efficiency, tissue ablation depth).
• For Software Verification and Validation: Software requirements specifications, design specifications, and coding standards. The "ground truth" would be whether the software performs as designed and intended, free of critical defects.

8. The Sample Size for the Training Set:

• Not applicable. This submission doesn't describe an AI/ML model that requires a training set of data. The "Virtual Basket" mode is a predefined pulse modulation algorithm, not a machine learning model trained on data.

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

• Not applicable. (See point 8.)

Summary of what the document does tell us about the device and its assessment:

• Device: Holmium laser surgical system (Cyber Ho 60/100, Litho 60/100).
• Modification: Addition of a "Virtual Basket" emission mode via software update.
• Basis for Submission: Device modifications (Special 510(k)).
• Predicate Devices: Litho 60 (K172025) and Litho 100 (K180922).
• Testing Performed:
  • Bench testing comparing the new "Virtual Basket" mode to the standard emission mode.
  • Software Verification and Validation testing (according to FDA guidance).
• Tests Not Repeated (as there was no hardware or architecture change that could affect them): Electromagnetic compatibility, electrical safety, and general performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Conclusion: The device is considered substantially equivalent to its predicate devices, indicating the modifications (including the new Virtual Basket mode) do not raise new questions of safety or effectiveness.

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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The subject device is derived from the legally marketed (unmodified) device Litho 60 (K172025). This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power and frequency.

This document describes the FDA clearance (K180922) for the Quanta System SPA's Holmium laser systems (Empower H100, Cyber Ho 100, Litho 100). However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance related to diagnostic accuracy, or human reader performance with or without AI assistance.

The submission is specifically a Special 510(k) for "Device modifications" to an already cleared device (Litho 60, K172025). This type of submission generally relies on demonstrating that the modified device remains substantially equivalent to the predicate device, primarily through engineering, performance, safety, and software testing, rather than new clinical efficacy studies.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance related to clinical outcomes.
• Sample sizes for test sets where clinical performance (e.g., diagnostic accuracy) would be evaluated.
• Number of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies or effect sizes of human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for clinical performance.
• Training set sample size or ground truth establishment for a training set (as this is not an AI/ML device where such details would be relevant to the submission type).

Based on the provided text, the acceptance criteria and study proving the device meets them are focused on engineering performance, safety, and software validation.

Here's what can be extracted from the document regarding acceptance criteria and performance testing for these modifications:

1. Acceptance Criteria and Reported Device Performance (as per a Special 510(k) for device modifications):

2. Sample Size and Data Provenance:
This document indicates that the tests conducted were primarily engineering/bench testing and software verification/validation. These types of tests do not typically use "patient data" or "test sets" in the context of clinical performance evaluation. The data provenance would be laboratory results from the manufacturer.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable for this type of submission. Ground truth for engineering tests is based on established scientific principles, physical measurements, and standard compliance.

4. Adjudication Method for Test Set:
Not applicable. These are objective engineering and software tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention any clinical studies, MRMC studies, or AI assistance for human readers. This is a laser surgical instrument, and the modifications are related to its hardware, software, and emission parameters, not an AI diagnostic component.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (laser), not a standalone algorithm.

7. Type of Ground Truth Used:
For the various tests conducted (electrical safety, EMC, laser safety, software), the "ground truth" is adherence to recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1) and internal design specifications, verified through objective measurements and checks.

8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

In summary, the provided FDA clearance letter and summary for K180922 focuses on demonstrating substantial equivalence through non-clinical testing for hardware and software modifications to an existing device, rather than new clinical efficacy studies or performance evaluation of an AI-driven system.

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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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