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The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device. It consists of: Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch

The provided document describes a 510(k) Premarket Notification for the Sphinx Jr Laser system. This type of submission in the US regulatory process for medical devices asserts substantial equivalence to a previously legally marketed device (predicate device), rather than directly demonstrating safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain a table of acceptance criteria nor a study proving the device meets said criteria in the traditional sense of a clinical trial. Instead, the core argument is that the Sphinx Jr Laser is substantially equivalent to existing predicate devices (Sphinx Family of Lasers K033437 and Lumenis - Versapulse K011703) because it shares the same intended use, indications for use, similar design features, and functional features.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent due to the nature of a 510(k) submission based on substantial equivalence:

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

• Acceptance Criteria: Not explicitly stated or defined in the document. For a 510(k) submission, acceptance is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance thresholds in de novo clinical studies.
• Reported Device Performance: The document states, "Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required." This implies that the performance is considered to be equivalent to the predicate devices, rather than providing new, original performance data against specific criteria.

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

• Sample Size: Not applicable. No "test set" in the context of a clinical performance study is described. The demonstration of equivalence relies on comparing the device's design, intended use, and functional specifications to those of the predicate devices.
• Data Provenance: Not applicable. No clinical data or performance data from human or animal subjects is described as being used to establish equivalence in this document.

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 a "test set" requiring ground truth establishment by experts in this 510(k) submission.

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

• Not applicable. No "test set" and thus no adjudication method for it 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. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

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

• Not applicable. This is not an algorithm-only device. It is a physical surgical laser system operated by medical professionals.

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

• Not applicable. No ground truth is established in the context of a performance study for the Sphinx Jr Laser. Its safety and effectiveness are inferred by its substantial equivalence to previously cleared devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would require a "training set."

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

• Not applicable. As above, no training set or ground truth for such a set is relevant to this device.

Summary of the Study and "Acceptance" for the Sphinx Jr Laser:

The "study" in this context is the 510(k) Premarket Notification (K132975) process itself, which aims to demonstrate substantial equivalence (SE) to predicate devices. The "acceptance criteria" are effectively the FDA's requirements for establishing SE.

The document states:

• "The Sphinx Jr systems with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Sphinx Family of Lasers K033437 and Versapulse K011703."
• "All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to support a determination of safety to the predicate devices." (This refers to non-clinical, engineering-level testing, not clinical performance).
• "Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required."
• Conclusion: "The Sphinx Jr Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices."

The FDA's letter on March 18, 2014, confirms that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This letter constitutes the "acceptance" that the device meets the regulatory requirements for market clearance via the 510(k) pathway, based on the argument of substantial equivalence.

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The RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery. and Arthroscopy

The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

Here's an analysis of the provided text regarding the acceptance criteria and study for the RevoLix Family of Laser Systems:

It is important to note that the provided document is a 510(k) Summary for a medical device (laser surgical instrument), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. As such, the information you've requested regarding specific acceptance criteria, sample sizes, expert qualifications, and ground truth for a study proving the device meets acceptance criteria (as would be found for a diagnostic AI device, for example) is largely not present in this type of submission.

The document describes bench testing to support substantial equivalence, but not a full-fledged clinical trial to establish quantitative performance against defined acceptance criteria in the way a diagnostic AI device would.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for a surgical laser), the "acceptance criteria" are primarily related to demonstrating substantial equivalence to existing predicate devices in terms of intended use, indications for use, and functional features, and similar performance characteristics in bench testing. Performance is described qualitatively, rather than via quantitative metrics with defined thresholds like sensitivity, specificity, etc.

Study Details (Based on the provided 510(k) Summary)

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

   • The document mentions "All necessary bench testing was conducted on the proposed family of RevoLix lasers." It does not specify the sample size (e.g., number of tissue samples, animals, or human subjects) used for these bench tests.
   • Data provenance: "Bench testing" generally refers to in-vitro or ex-vivo testing in a laboratory setting, not patient data. No specific country of origin is mentioned, but typically such testing would occur in the manufacturer's R&D facilities or contracted labs. The testing appears to be "prospective" in the sense that it was performed specifically for this submission.

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

   • This information is not provided. For physical performance testing of a laser, "ground truth" would likely be established by objective measurements (e.g., using calibrated instruments for depth, temperature, visual assessment of tissue effects) rather than expert consensus on interpretive data.

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

   • This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for evaluating the interpretation of medical images or diagnostic outputs, where subjective assessment by multiple readers is required. For bench testing of a laser's physical effects, objective measurement and comparison to specifications or predicate device performance are the primary methods.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This submission is for a surgical laser, where the primary function is direct tissue interaction, not aiding human readers in interpretation.

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

   • Not applicable. This device is a surgical laser system, which is inherently a human-in-the-loop device (a surgeon operates it). It is not an algorithm or AI system.

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

   • The ground truth for the bench testing would be objective physical measurements (e.g., direct measurement of thermal injury depth, ablation depth, observation of tissue effects like carbonization) and comparison to the known performance of the predicate device. Pathology or outcomes data would be part of clinical trials, which are beyond the scope of this 510(k) summary focused on substantial equivalence via bench testing.

7. The sample size for the training set:

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

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

   • Not applicable. This device is not an AI/ML algorithm requiring a training set with ground truth.

Summary of what the document does provide regarding the "study" (bench testing):

The "study" refers to bench testing performed on the RevoLix family of lasers. This testing aimed to demonstrate that the new devices perform in a "comparable" manner to the predicate device in terms of direct tissue effects. The key findings were:

• Depth of thermal injury and coagulation: No "significant differences" when compared to the RevoLix 120 (predicate).
• Ablation depth: "Comparable depth" with an adjustment in translation speed.
• Other tissue effects (e.g., carbonization): "Comparable."

This information supports the claim of substantial equivalence, which is the core requirement for a 510(k) clearance, rather than establishing novel quantitative performance metrics for a diagnostic or AI device.

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The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery

The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece

The provided text is a 510(k) summary for the FlexGuard device and a clearance letter from the FDA. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device.

The FlexGuard is a family of flexible sheaths designed to protect flexible scopes or surgical devices from mechanical damage when a laser fiber is introduced. It is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, the questions about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment (pathology, outcomes data) as they relate to AI/ML device performance are not applicable to this submission.

The document discusses the device's intended use, its components, and its substantial equivalence to a predicate device, which is typical for a 510(k) submission for a non-AI/ML device.

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The Revolix Duo continuous wave 2.01 micron 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 hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Revolix Duo pulsed Holmium 2.1 micron 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 hemostasis of soft and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

The provided text is a 510(k) Summary for the Revolix Duo Laser System (K070466). Due to the nature of 510(k) submissions for Class II medical devices like surgical lasers, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than performing a de novo clinical study with explicit acceptance criteria for device performance.

Therefore, the input document does not contain the detailed information requested regarding acceptance criteria, a specific study proving the device meets those criteria, test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, ground truth types for test sets, training set sizes, or how training set ground truth was established.

Instead, the "study" proving the device meets acceptance criteria (via substantial equivalence) is the comparison to predicate devices.

Here's a breakdown of why the requested information is absent and what the document does provide:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a new device. The "acceptance criteria" here are implicitly that the Revolix Duo Laser System performs equally well or similarly enough to the predicate devices for the specified indications for use, without raising new questions of safety and effectiveness.

• Reported Device Performance: Not presented as a distinct performance evaluation from a clinical trial. The "performance" is considered equivalent to that of the predicate devices.

  Acceptance Criteria (Implied)	Reported Device Performance
  Substantial equivalence to predicate devices (Lisa Laser RevoLix continuous wave 2 micron laser and Lisa Laser Sphinx 80 Watt Holmium Laser (K070466)) for stated Indications for Use.	The Revolix Duo Laser System was found to be substantially equivalent to the predicate devices for its intended use and indications for use.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical performance study with a distinct "test set" of patient data.
• Data Provenance: Not applicable. The submission relies on the established safety and effectiveness of the predicate devices, not on new clinical data from the Revolix Duo system itself.

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

• Not applicable. There is no mention of a test set with expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a laser surgical instrument, not an AI diagnostic device that would typically involve human readers or MRMC studies.

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

• Not applicable. This device is not an algorithm, it's a physical surgical laser system that requires a human operator. Its performance is inherent to its physical operation, not an algorithm's output.

7. The type of ground truth used:

• Not applicable in the context of a new performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable.

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The Revolix 120 laser systems 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 hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy

The RevoLix 120 laser system is diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

The provided 510(k) summary for the RevoLix 120 Laser System does not contain acceptance criteria or study data demonstrating the device meets such criteria.

The document is a premarket notification for substantial equivalence, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission typically relies on a comparison of design, materials, and intended use to predicate devices, rather than new clinical trials or detailed performance acceptance criteria.

Therefore, I cannot provide the requested table and information as it is not present in the given text. The document focuses on:

• Device identification and classification.
• Identification of predicate devices: Lumenis/Coherent Medical - VersaPulse Ho:YAG 100 watt, Trimedyne Omnipulse Max 80 watt, RevoLix 90 watt.
• Product description: Diode pump solid state surgical laser system operating at 2.01 micron for ablation, coagulation, dissection, and resection of soft tissue.
• Indications for Use: Extensive list across various medical specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, Arthroscopy).
• Rationale for Substantial Equivalence: Stating the RevoLix 120 shares "the same intended use, indications for use, similar design features and functional features" with the Lumenis VersaPulse Laser.
• Conclusion: The device was found substantially equivalent to predicate surgical laser systems.

In summary, none of the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies is available in this 510(k) submission. These details would typically be found in performance data sections of a 510(k) submission, clinical trial reports, or other regulatory filings, which are not included here.

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The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy

The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument.

It consists of:

Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

This document is a 510(k) summary for the AllMed Systems Inc. RevoLix and RevoLix Jr laser systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, this submission is focused on demonstrating substantial equivalence to predicate devices already on the market, as required for a 510(k) premarket notification to the FDA. The rationale for substantial equivalence is stated as sharing the "same intended use, indications for use, similar design features and functional features" with the Lumenis VersaPulse Laser.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size regarding human reader improvement with AI assistance. (This device is a surgical laser, not an AI-assisted diagnostic tool).
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document serves as a regulatory submission for a medical device (surgical laser) and not a performance study report. The FDA's letter (pages 5-7) confirms the substantial equivalence determination but doesn't detail performance studies against specific acceptance criteria beyond typical safety and efficacy assessments inherent in medical device clearance.

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The Sphinx 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 hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Sphinx system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

This submission focuses on establishing substantial equivalence for a surgical laser system (Sphinx) to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI performance is not applicable or cannot be extracted from this document.

Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's function. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to existing predicate devices. This means proving that the Sphinx laser system has the same intended use, indications for use, and similar design/functional features as the predicate devices.
• Reported Device Performance: The document does not provide quantitative performance metrics for the Sphinx laser system such as power output accuracy, beam stability, or tissue ablation rates against specific benchmarks. It describes the device's capabilities (ablation, coagulation, dissection, resection of soft tissue) and its intended applications across various medical specialties.

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

• Not Applicable. This submission is not based on a clinical performance study using a test set of patient data to evaluate an AI/CAD device's diagnostic or predictive performance. It's a regulatory submission affirming substantial equivalence based on technical specifications and intended use.

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

• Not Applicable. As there is no "test set" in the context of an AI/CAD device's performance, there were no experts used to establish ground truth for such a set. The "ground truth" here would be the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or adjudication process for AI/CAD performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document does not mention an MRMC study. It is a submission for a surgical laser device, not a diagnostic imaging AI.

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

• Not Applicable. This is a hardware device (laser system), not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable / Implied Equivalence: The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and efficacy of the predicate devices (Lumenis - Holmium VersaPulse Power Suite Holmium Laser and Trimedyne - OmniPulse Max 80 Watt Holmium Laser System). The "proof" for the Sphinx system is its demonstration of substantial equivalence to these legally marketed devices, implying that if it is sufficiently similar, it can be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. See point 8.

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The Revolix 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 hemostasis of soft tissue in use in medical specialities including: Urology, Gasteroenterlogy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The RevoLix diode pump solid state is a surgical laser system operating at a wavelength of 2.0 micron. The purpose of the laser is the ablation, coagulation, and hemostasis of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via a fiber optic delivery system and this is guided by a handpiece or endoscopic surgical instrument. It consists of Laser Console with Internal Computer Control Panel and Display, A fiber optic delivery system, Footswitch.

The provided text is a 510(k) Summary for the RevoLix Family of Laser Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. For laser systems, substantial equivalence is typically established based on similar intended use, technological characteristics, and safety profiles.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.

The document states:

• Rationale for Substantial Equivalence: The RevoLix laser system shares "intended use, indications for use, similar design features and functional features" with the predicate devices.
• Conclusion: The RevoLix Laser System was found to be "substantially equivalent" to the predicate surgical laser systems.

This type of submission focuses on regulatory comparison, not on detailed performance validation with specific acceptance criteria and study designs as would be expected for a software-as-a-medical-device (SaMD) or AI-based diagnostic tool.

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