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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 Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, 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 is indicated for use in medicine and surgery, in the following medical specialties:

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

The Solvo is a modification to Dornier's Medilas H20 Laser K061455.

The provided text describes a 510(k) summary for the Medilas H Solvo Holmium Laser, which is a modification of an existing device. This document is a regulatory submission for substantial equivalence and does not contain any information regarding clinical studies or device performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device.
• Identifying the predicate device.
• Stating the intended use and indications for use.
• Asserting substantial equivalence to the predicate device based on design specifications and technological characteristics, without presenting any new performance data.

The FDA's letter (Sections 2 and 3) acknowledges the 510(k) submission and confirms that the device is substantially equivalent for the stated indications for use, subject to general controls. It does not refer to any performance data or clinical studies in this context.

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The Dornier Medilas H 20 Laser is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, 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 coaqulation of soft tissue. The Dornier Medilas H 20 Laser 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 20 Laser is a pulsed solid-state Holmium:YAG laser system. The Dornier Medilas H 20 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 400pm (0.4mm). The Dornier Medilas H 20 Laser incorporates a graphic display panel with touch screen capabilities allowing the operator to control the functions and laser parameters of the laser pulse control panel regulates the pulse energy, pulse frequency, pulse mode (continuous mode, pedalcontrolled repetitive burst mode and control panel bursts mode), pilot brightness, and various Menu functions. The Dornier Medilas H 20 Laser light emission is transmitted to the application site by a sterile fiber optic delivery systems or fiber optic cables with a SMA 905 connector.

This document is a 510(k) summary for the Dornier Medilas H 20 Laser and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices to establish substantial equivalence under the 510(k) pathway, which typically does not require new clinical performance studies with specific acceptance criteria in the same way a PMA or de novo submission might.

Here's what can be inferred from the document regarding the "study" for this submission:

• Type of "Study": This is a predicatibility study (comparison to predicate devices), not a performance study with acceptance criteria. The "study" here involves demonstrating that the Dornier Medilas H 20 Laser is "substantially equivalent" to already approved devices.
• Proof of Meeting "Acceptance Criteria": The "acceptance criteria" for a 510(k) submission are met when the FDA determines the new device is substantially equivalent to a predicate device. This is primarily done by showing it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Specific points from the document that relate to the comparison:

• Predicate Devices:
  • Dornier Medilas H Laser (K981718)
  • Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012)
  • Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703)
• Comparative Technological Characteristics (used for showing equivalence, not acceptance criteria for performance):
  • Principles of Operation: Same basic operational features for Holmium YAG lasers with flash lamp emission.
  • Laser Type: Solid State Holmium HO:YAG lasers (equivalent).
  • Maximum Radiant Power: 20 Watts (equivalent to predicates).
  • Wavelength: 2080nm (new device) vs. 2100nm (predicates) - deemed equivalent.
  • Energy Output: 1.8J to 2.5J (equivalent to predicates).
  • Pulse Duration: 350us (new device) vs. 250us (predicates) - deemed equivalent.
  • Cooling Method: Integrated water cooling system with water/air exchangers (equivalent).
  • Operational Modes: Continuous and pulse modes (equivalent).
  • Delivery Systems: Ethylene oxide sterilized fiber optic delivery systems with SMA 905 connector (equivalent).
• Intended Use: The Dornier Medilas H 20 Laser has the same indications for use as the predicate device Dornier Medilas H Laser (K981718), and the same general indications for use as the other two predicates.
• Safety and Effectiveness Information: The document states that "Safety and effectiveness information was provided in the Premarket Notification to demonstrate that the Dornier Medilas H 20 Laser is safe and effective..." However, the nature of this information (e.g., specific test results, clinical data) is not detailed in this summary. It's typical for 510(k)s to rely on non-clinical (bench) testing and comparison to predicates rather than extensive human clinical trials to demonstrate safety and effectiveness for substantial equivalence.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research study with performance-based acceptance criteria.

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The Dornier Medilas™H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas™ H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

The Dornier Medilas™ H Laser Fiber Cables used in this premarket notification are the same accessory devices as in the previously cleared Dornier Medilas™ H Laser System under 510(k) #K984591 and maintain the same previously cleared indications for use as stated below.

This document is a 510(k) summary for a medical device (Dornier Medilas™ H Laser Fiber Cables). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the prompt's requested information, which is tailored for performance studies proving a device meets acceptance criteria (especially relevant for AI/ML devices), is not applicable in this context.

Here's why and how I'll address your request based on the provided text:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The safety and effectiveness of the Dornier Medilas™ H Laser Fiber Cables are based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." It further emphasizes: "Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the Dornier Medilas™ H Laser Fiber Cables and the predicate device."
• Substantial Equivalence: The entire submission is built on the concept of substantial equivalence to a legally marketed predicate device (SlimLine Fibers in 365, 550 and 1,000 micron sizes, 510(k) #K980685). This means the manufacturer is asserting their device is as safe and effective as the predicate, not that it meets specific, novel performance metrics via a new study.
• No AI/Software Component: The device is a laser fiber cable, a hardware component. There is no mention or indication of any AI or software component, which would typically necessitate the kind of performance study and ground truth establishment described in your prompt.

Given this, I cannot provide the requested table or answer most of the questions because the information is not present in the provided 510(k) summary. The document does not describe a study to prove acceptance criteria in the manner of an AI/ML device.

Response based on available information:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics but implicitly the device must be "substantially equivalent" to the predicate device in terms of safety and effectiveness.
   • Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity) or clinical study results are reported to demonstrate meeting novel acceptance criteria. The performance is asserted to be equivalent to the predicate.

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. No new performance study or test set described.

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

   • Not applicable. No ground truth establishment for a performance study described.

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

   • Not applicable. No test set or adjudication 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. This device is a laser fiber cable, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Not applicable. No ground truth for a performance study described.

8. The sample size for the training set:

   • Not applicable. This device is a laser fiber cable. There is no AI/ML model requiring a training set.

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

   • Not applicable. No AI/ML model or training set described.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to a previously cleared device, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.

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The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

Not Found

I am sorry, but the provided text is a 510(k) summary for a medical device (Dornier Medilas H/2 Laser) and does not contain the kind of study information (acceptance criteria, sample sizes, expert qualifications, ground truth, etc.) that you are asking for.

The 510(k) summary focuses on establishing "substantial equivalence" of the new device to a predicate device already on the market, rather than presenting a performance study with detailed acceptance criteria and study data. It primarily discusses:

• Device Name, Submitter, and Contact Information: Basic identification details.
• Classification Name and Predicate Devices: How the device is categorized and which existing device(s) it is compared to for regulatory purposes.
• Intended Use and Indications for Use: What the device is designed to do and for which medical conditions/procedures. In this case, it's for cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties.
• Technological Characteristics and Substantial Equivalence: The core of a 510(k), where the manufacturer argues that their new device is similar enough to an already legally marketed device (the predicate) that it does not raise new questions of safety or effectiveness. The key point here is that the only minor difference mentioned is the replacement of a contraindication with a precaution statement regarding kidney and bladder stone fragmentation.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically include detailed performance data, acceptance criteria, and study methodologies.

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The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.

This document describes a 510(k) submission for the Dornier Medilas H Pulsed Laser. The provided text is a summary seeking clearance for the device, and as such, it does not detail a study proving the device meets specific performance acceptance criteria in the manner one might find for a diagnostic or AI-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, many of the requested elements regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a laser device demonstrating substantial equivalence, explicit "acceptance criteria" for a specific disease or diagnostic task are not provided in the same way they would be for a clinical diagnostic device.

The "performance" is primarily focused on demonstrating that the device operates safely and effectively within established laser standards and is technologically similar to predicate devices.

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

This is not applicable. The submission does not describe a clinical study in the traditional sense involving a "test set" of patient data. It relies on technological comparison and compliance with standards rather than clinical performance data against a specific disease outcome.

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

This is not applicable. No ground truth for a test set was established as no such study is described.

4. Adjudication Method for the Test Set

This is not applicable. No test set requiring expert 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

This is not applicable. This is not an AI-assisted diagnostic device, but a surgical laser. No MRMC study was performed.

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

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

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

This is not applicable. The submission is based on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards for laser devices, not on a ground truth related to a specific disease diagnosis or outcome in a study. The closest concept to "ground truth" here would be the established safety and efficacy profiles of the predicate devices and the regulatory standards themselves.

8. The Sample Size for the Training Set

This is not applicable. This is not a machine learning device that requires a training set.

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

This is not applicable. As above, this is not a device requiring a training set with established ground truth.

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