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The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surqical procedures in urology.

MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container. The device is available with either sterile single use blades and non-sterile reusable blades.

The provided text is related to a medical device submission (K240831) for the MultiCut Solo Morcellator. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a new device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in the provided text.

The document states that the MultiCut Solo Morcellator is a modification of an already cleared device (K213597), with the specific modification being the addition of sterile single-use blades. The submission focuses on non-clinical performance data to support the substantial equivalence.

Here's what can be extracted from the text regarding the device's assessment:

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

• No specific acceptance criteria or performance metrics related to diagnostic accuracy or clinical outcomes are provided. The submission focuses on product safety and function rather than a software algorithm's diagnostic performance.
• The document mentions that the device "successfully passed the following testing" and "is in compliance with all applicable sections of the above-mentioned performance standards." These relate to the safety and functionality of the device and its components, particularly the new sterile single-use blades. The "performance" in this context refers to meeting engineering and safety standards, not clinical diagnostic accuracy.

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

• Not applicable. The document describes non-clinical performance data (e.g., sterilization validation, biocompatibility) rather than a test set for diagnostic 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. There is no mention of expert-established ground truth for a diagnostic test set.

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

• Not applicable. No test set requiring adjudication is 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 applicable. The MultiCut Solo is a mechanical morcellator, not an AI diagnostic device, and thus no MRMC study would be relevant.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. The assessments made (e.g., sterilization effectiveness, biocompatibility) are based on established scientific methods and standards (e.g., EN/ISO 10993, IEC 60601 series) rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. The device is not based on machine learning or AI that would require a training set.

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

• Not applicable.

In summary, the provided FDA 510(k) summary focuses on the technical safety and performance of a medical device (a morcellator) and its components, specifically regarding modifications and substantial equivalence to a predicate device, rather than on the diagnostic accuracy or clinical efficacy that would involve the type of acceptance criteria and study designs typically associated with AI/software-as-a-medical-device (SaMD) clearances.

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Dermablate System with its accessories is indicated for coagulation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The device can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

This document, a 510(k) Premarket Notification summary for the Dermablate laser system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) cannot be extracted directly from this document.

The document outlines that "Dermablate passed all the required testing and is in compliance with all applicable sections of the abovementioned performance standards," which implies that the device did meet acceptance criteria related to these standards, but the specific performance results or acceptance thresholds are not detailed.

Here's an analysis of the information available:

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

The document does not provide a table of specific acceptance criteria (e.g., target energy output with an allowable deviation) and the device's reported performance against these criteria. Instead, it lists harmonized standards that the device passed. Compliance with these standards is the reported performance in this context, demonstrating that the device meets safety and electromagnetic compatibility requirements, among others.

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

This information is not provided in the document. The testing described (performance testing, software V&V, biocompatibility) typically involves engineering tests, hardware verification, and software validation rather than patient-level clinical studies with test sets in the context of AI/diagnostic devices.

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)

This information is not applicable/provided. The Dermablate is a laser surgical instrument, and its performance evaluation documented here revolves around technical and safety specifications rather than diagnostic accuracy established by expert consensus on a test set.

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

This information is not applicable/provided. As explained in point 3, the evaluation of this device does not involve expert adjudication of a test set in the way a diagnostic AI would.

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

An MRMC comparative effectiveness study is not applicable here. The Dermablate is a therapeutic laser device, not a diagnostic AI system designed to assist human readers.

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

This concept is not applicable to a therapeutic laser device. The device's function is direct treatment, not an algorithmic standalone performance for diagnosis or image analysis.

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

The document does not detail "ground truth" in the context of clinical outcomes or diagnostic accuracy. For a laser device, "ground truth" would relate to its physical output parameters (wavelength, energy, fluence, etc.) matching specifications, and its safety compliance with international standards. The document states that the device "passed all the required testing and is in compliance with all applicable sections of the above-mentioned performance standards," implying that these standards' requirements serve as the "ground truth" for technical and safety performance.

8. The sample size for the training set

This information is not applicable/provided. The Dermablate is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided. As above, the device does not use a training set.

Summary of available information regarding compliance and efficacy (as per the document):

The document focuses on demonstrating substantial equivalence of the modified Dermablate device (increased max pulse energy to 3J and addition of a "DeepSpot" microbeam handpiece) to its predicate devices (MCL 31 Dermablate and Erise). The "study" proving the device meets acceptance criteria is implied through its successful passage of various harmonized standard tests and software verifications and validations.

The key statement is: "Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards." and "Dermablate passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."

The listed standards that the device passed are:

• IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1: General requirements for safety and essential performance
• IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 62304: Medical Device Software – Software life cycle processes
• IEC 62366-1:2015: Medical devices – Application of usability engineering to medical devices
• IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirement
• ISO 14971: Medical devices - Application of risk management to medical devices
• FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software V&V)
• EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
• ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation

The "acceptance criteria" are compliance with these standards, and the "reported device performance" is that it did comply. The document does not elaborate on the specific test results or the criteria defined within each standard that the device had to meet (e.g., maximum electromagnetic emissions or specific laser output tolerances).

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The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology.

The MeDioStar laser system is intended for the treatment of benign vascular lesions.

The MeDioStar laser system is intended for the treatment of benign pigmented lesions.

The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months ..

The modified MeDioStar is a pulsed diode laser emitting a wavelength of 755 - 1060 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

The provided text describes modifications to an existing laser system, the "MeDioStar," focusing on an expanded wavelength range. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics for its stated indications for use (e.g., hair reduction, treatment of vascular/pigmented lesions).

The document primarily focuses on:

• Regulatory Clearance (510(k) summary): Confirming that the modified device is substantially equivalent to a predicate device.
• Device Description: Outlining the technical specifications and modifications from the previous version.
• Performance Standards (Non-clinical): Listing the electrical safety, electromagnetic compatibility, software, usability, risk management, and laser-specific safety standards that the device passed. These standards ensure the device is safe and functions correctly from an engineering perspective, but not necessarily its clinical efficacy for its stated indications.

Therefore, for your specific request, most of the information is not present in the provided document. I can only report on what is available.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists performance standards the device passed, which are primarily related to safety and engineering aspects, not clinical efficacy or specific acceptance criteria for its intended uses (hair reduction, lesion treatment). Therefore, a table for clinical performance criteria and results cannot be generated from this text.

The document states:

• "MeDioStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."

The performance standards mentioned are:

• ISO 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance
• ISO 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 62304: Medical Device Software – Software life cycle processes
• IEC 62366-1: Medical devices Application of usability engineering to medical devices
• IEC 60601-2-22: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• ISO 14971: Medical devices – Application of risk management to medical devices
• Software verification and validation testing (according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").

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

Not provided. The document does not describe any clinical test sets or studies related to the device's efficacy for its intended uses.

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 provided. There is no mention of clinical experts or ground truth establishment for clinical performance.

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

Not provided.

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. This is a laser device, not an AI-assisted diagnostic tool for human readers.

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

Not provided. This is a laser device, not an AI algorithm performing a standalone task.

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

Not provided. No clinical ground truth is discussed.

8. The sample size for the training set

Not provided. No training set for an algorithm is mentioned.

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

Not provided. No training set or ground truth for it is mentioned.

In summary: The provided FDA 510(k) clearance letter and summary primarily address the safety and engineering compliance of a modified medical laser device (MeDioStar) compared to its predicate. It confirms that the device meets various international and FDA standards for electrical safety, software, usability, and risk management. However, it does not include information about clinical performance studies, efficacy acceptance criteria, or any data related to how well the device performs for its stated indications (e.g., hair reduction, treatment of lesions). Such clinical data, if required for a 510(k), would typically be referenced or summarized, but none appears in this document.

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Laser Device:

The MultiPulse HoPLUS 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: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) 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, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma 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 / Orthopedic surgery (excision, ablation 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 Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular 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 Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

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

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

Laser Device:

The MultiPulse HoPLUS 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: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) 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, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma 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 / Orthopedic surgery (excision, ablation 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 Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular 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 Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

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

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

This document is an FDA 510(k) clearance letter for the MultiPulse HoPLUS Laser system and MultiCut Solo Morcellator. It outlines the regulatory approval and intended uses of the device.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond its substantial equivalence to predicate devices and adherence to general controls.

The document primarily focuses on:

• Confirming the 510(k) clearance (K231876) for the MultiPulse HoPLUS Laser and MultiCut Solo Morcellator.
• Stating its classification as a Class II device.
• Listing its broad Indications for Use across various medical specialties (Urology, Gastroenterology, Arthroscopy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery).
• Mentioning regulatory requirements and guidance documents.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided FDA clearance letter.

The FDA 510(k) pathway for medical devices largely relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics or comparison against specific, pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission might. While the manufacturer would have submitted data to the FDA to support the substantial equivalence claim, the details of those studies and specific acceptance criteria are not typically included in the public-facing clearance letter.

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The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

The MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container.

The provided text describes a 510(k) submission for a medical device called "MultiCut Solo Morcellator." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance standards. Itdoes not contain information about a clinical study involving a dataset, human readers, or AI assistance. Therefore, I am unable to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The information provided is typical for a traditional medical device 510(k) submission, detailing:

• Device Description: MultiCut Solo Morcellator, an endoscopic handpiece with a motor-driven blade for mechanical tissue shredding and aspiration.
• Intended Use: Transurethral mechanical morcellation and removal of prostate adenoma after enucleation during endoscopic surgical procedures in urology.
• Nonclinical Performance Data:
  • Compliance with various IEC/EN/ISO standards for electrical safety, EMC, software lifecycle, risk management, and biocompatibility.
  • "Comparative bench testing has been performed to show the performance equivalence of the subject device to its predicate."
• Comparison to Predicate Devices: A detailed table comparing the MultiCut Solo to two predicate devices (VersaCut + Morcellator and MORCE SCOPE SET 8970) across various characteristics like principle of operation, intended use, speed regulation, dimensions, materials, power supply, rotation speed, aspiration, electrical requirements, suction pump, and reusability.

Based on the provided document, the following items CANNOT be addressed as they are not present in the text:

• A table of acceptance criteria and reported device performance related to a data-driven or AI/ML study. The "acceptance criteria" discussed are primarily compliance with safety and performance standards for a mechanical device.
• Sample size used for the test set and data provenance. No test set of data (like images or patient records) is mentioned.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document concludes that "The non-clinical performance testing conducted supports that the device can be used safely and effectively. The differences in the indications for use and technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices." This statement refers to bench testing, compliance with design standards, and similarity to existing devices, not a study proving performance on a clinical dataset.

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The PicoStar laser system is indicated for the following at the specified wavelength:

532 nm:

Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.

1064 nm:

Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Only with microspot handpiece. indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.

The provided text is a 510(k) summary for the PicoStar laser system. It outlines the device's indications for use, technological characteristics, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/machine learning medical device.

The document states:

• "Clinical Performance Data: None" on page 6.
• "Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". PicoStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards." on page 5. This refers to software engineering practices, not a performance study of an AI algorithm based on clinical data.

The PicoStar device is a laser surgical instrument, and its clearance is based on substantial equivalence to a predicate laser device, supported by non-clinical performance data (electrical safety, EMC, software lifecycle processes, risk management) and biocompatibility, not by a clinical study on AI performance metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document. The document pertains to the regulatory clearance of a laser device, not an AI/ML-driven diagnostic or therapeutic device that would require such performance studies.

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The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

The provided text is a 510(k) summary for the MCL 31 Dermablate System, a pulsed Er:YAG laser. It details the device's technical characteristics, intended use, and compares it to legally marketed predicate devices. However, this document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with various safety and performance standards. It does not present a study with specific acceptance criteria related to a device's diagnostic or therapeutic performance, nor does it report on a device's performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as such a study is not part of this 510(k) summary. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical performance studies to establish new performance metrics.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for test sets.
3. Details on the number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Nonclinical Performance Data" section lists various engineering and biocompatibility standards the device complied with, such as:

• EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-2-22 (Particular requirements for laser equipment)
• EN/IEC 60825-1 (Safety of laser products)
• IEC 62304 (Medical Device Software - Software life cycle processes)
• ISO 14971 (Risk management)
• EN/ISO 10993-1, -5, -10, -23 (Biocompatibility testing for cytotoxicity, sensitivity, and irritation)

These are standards that the device must meet for safety and basic performance, not metrics measuring its effectiveness in treating patients or its diagnostic accuracy. The compliance with these standards is considered sufficient for substantial equivalence in this context, aligning with the "General controls provisions of the Act" mentioned in the FDA letter.

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The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and in dermatology.

The MeDioStar laser system is intended for the treatment of benign vascular lesions.

The MeDioStar laser system is intended for the treatment of benign pigmented lesions.

The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

The MeDioStar is a pulsed diode laser emitting a wavelength of 750 - 950 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

This document is a 510(k) Pre-Market Notification for a medical device, specifically a laser system. It outlines the modifications to an existing device, the MeDioStar, and demonstrates its substantial equivalence to previously cleared predicate devices.

Based on the provided document, there is no information regarding acceptance criteria, reported device performance metrics against those criteria, or clinical study details (sample size, data provenance, expert adjudication, MRMC, standalone algorithm performance, ground truth establishment for test or training sets).

The document explicitly states: "Clinical Performance Data: None".

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through:

1. Technical Modifications: Listing specific changes from the predicate device (e.g., GUI design, handpiece port, repetition rate, handpieces, USB drive).
2. Comparison of Technical Characteristics: A table comparing the subject device (MeDioStar) to its main predicate (MeDioStar NeXT Family) and two reference predicates (Primelase Excellence, LightSheer Infinity/Duet/Desire) across various parameters like laser source, wavelength, pulse duration, fluence, repetition rate, intended use, and handpiece ports.
3. Non-clinical Performance Data: Listing standards to which the device complies (e.g., ISO 60601-1, IEC 62304, ISO 14971) and stating that software verification and validation testing were conducted successfully.

The FDA 510(k) process for this device type often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring new clinical studies and performance benchmarks against specific acceptance criteria. This is particularly true for modifications to existing cleared devices, as is the case here ("Special 510(k)").

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The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories

The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about specific acceptance criteria for performance, a study to prove the device meets those criteria, or details regarding sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document states:

• Non-clinical Performance Data: "Verification and Validation activities. These activities comprises the verification and validation of the software, the verification of the device, the verification of the fiber, the verification of the laser, an Investigation Report and the Final Test Report. These investigations lead to the conclusion, that the device is as safe and effective as the predicates and no additional risks occur."
• Clinical Performance Data: "None"

Therefore, based on the provided text, I cannot complete most of the requested information. The device's substantial equivalence is based on non-clinical performance data (verification and validation) and comparison to predicate devices, not on a specific clinical study with defined acceptance criteria and human expert evaluation in the way requested.

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The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.

The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. The system incorporates a suction unit for the safe removal of laser plume.

This document is a 510(k) Pre-Market Notification for the Asclepion Laser Technologies GmbH MicroSpot Handpiece. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical study for novel performance claims. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted from this document.

However, based on the provided text, here is what can be inferred and what information is not available:

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

This document does not specify formal clinical acceptance criteria or report on device performance against such criteria. The "performance" described relates to technical characteristics and safety testing for substantial equivalence.

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

• Animal Performance Data (Histological Study):
  • Sample Size: 9 pigs.
  • Data Provenance: Not explicitly stated, but the company is based in Germany. The study appears to be prospective (controlled experimental application of the device).

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 specified in the document. The histological samples were collected and presumably analyzed by experts, but their number and qualifications are not provided.

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

• Not specified.

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 document describes a laser handpiece, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• Not applicable, as this is not an algorithm-based device.

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

• Animal Performance Data (Histological Study): Histological analysis of biopsied pig skin samples. This serves as a form of ground truth for assessing tissue response, ablation depth/width, and thermal damage.

8. The sample size for the training set

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

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

• Not applicable.

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