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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (

The provided document describes the troCarWash™ System, a device intended to remove visual obstructions from the distal lens of a laparoscope during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it details various validation and testing activities with implied acceptance criteria being successful completion of these tests according to specified standards.

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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the The disposable portion of the system is sterilized via irradiation and has limited (

The provided FDA 510(k) summary for the troCarWash™ System focuses on a device that removes visual obstructions from laparoscope lenses during surgery. The submission describes various non-clinical tests (packaging, sterilization, biocompatibility, electrical safety/EMC, software verification/validation, and bench performance testing) to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the specific information required to answer many parts of your request, particularly regarding:

• Acceptance criteria values for performance (e.g., target accuracy, sensitivity, specificity, or specific cleaning efficacy metrics). The text states "the troCarWash™ system was able to achieve acceptable cleans" but doesn't quantify what "acceptable" means.
• Detailed study design for performance evaluation beyond "Bench Performance Testing." While it mentions "wash efficacy," it doesn't provide specific metrics.
• Sample size and data provenance for a "test set" in the context of AI/ML or comparative studies with human readers.
• Details on expert ground truth establishment, adjudication methods, or MRMC studies.
• Information about a training set for an AI/ML model or how its ground truth was established. This device is a mechanical cleaning system, not an AI/ML diagnostic or therapeutic device, so these concepts (training set, experts for ground truth) likely don't apply in the way you're asking.
• Standalone performance metrics (e.g., Sensitivity, Specificity, AUC) typical of AI/ML devices.

Based on the provided document, here's what can be inferred and what information is missing:

Device Description: The troCarWash™ system is a laparoscopic lens cleaning device consisting of a reusable control unit and a disposable, sterile, single-use trocar. It removes visual obstructions (condensation, blood, tissue particulates) from the distal lens of a laparoscope to maintain a clear image during surgery. It uses medical-grade CO2 and saline for cleaning.

Nature of Device: This is primarily a mechanical/electromechanical device, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions related to AI/ML specific performance metrics (e.g., human reader improvement with AI assistance, training data, ground truth establishment by experts for AI models) do not directly apply to the described device and the information provided. The "Software Verification and Validation Testing" section explicitly states the software was considered "minor" level of concern, implying it's not performing complex diagnostic or decision-making functions typically associated with AI.

Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or performance metrics for wash efficacy (e.g., percentage of debris removed, clarity score), a table as requested cannot be fully populated. The closest statement is:

Study Information (Based on available text):

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

   • Acceptance Criteria for Wash Efficacy: Not explicitly quantified in the provided text. It states "acceptable cleans."
   • Reported Device Performance for Wash Efficacy: "The study demonstrated that with various scope angles and brands, the troCarWash™ system was able to achieve acceptable cleans." (No quantitative metrics provided).

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

   • Sample Size: "29 disposable sets (trocar, obturator, and tubing set) preconditioned with sterilization and accelerated aging and 8 disposable sets preconditioned with sterilization and simulated transportation and distribution were tested for wash efficacy." This totals 37 disposable sets.
   • Data Provenance: The document does not specify the country of origin. The study was a "benchtop model" performance test, implying controlled laboratory conditions rather than retrospective or prospective clinical data.

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

   • Not applicable. This device is evaluated for its mechanical cleaning performance, not for diagnostic accuracy requiring expert interpretation or ground truth labeling in the context of an AI/ML model. The "acceptable cleans" would likely have been determined against pre-defined visual or technical criteria, not expert consensus on medical images.

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

   • Not applicable. This type of adjudication method is used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements and establish ground truth for image-based diagnostic systems. It is not relevant for a mechanical cleaning efficacy test.

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

   • No, an MRMC study was not done. The document explicitly states: "No clinical data was necessary to support a claim of substantial equivalence." This type of study is typically performed for AI/ML diagnostic aids to show improvement in human reader performance.

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

   • The "Bench Performance Testing" section describes testing the system's ability to clean without direct human intervention in the cleaning process itself (though human operation initiates the cycle). However, this is not "standalone algorithm performance" in the context of AI/ML, but rather the performance of the device's mechanical function. No specific quantitative diagnostic metrics (like sensitivity, specificity, AUC) are provided.

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

   • For wash efficacy: The ground truth would likely be defined by pre-established physical/visual criteria for lens cleanliness after contamination, rather than expert consensus on medical images or pathology. The document doesn't detail these criteria, only that "acceptable cleans" were achieved.
   • For other tests (packaging, sterilization, biocompatibility, electrical safety): Ground truth is established by compliance with recognized industry standards and test methods.

8. The sample size for the training set:

   • Not applicable / Not specified. This device is not an AI/ML model that requires a "training set" in the computational sense. Its design and operation are based on engineering principles, and its software is "minor" in terms of risk, suggesting it's primarily for control, not learning.

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

   • Not applicable. As no AI/ML training set is mentioned or implied, this question does not apply.

Summary of Gaps: The provided text is a 510(k) summary for a mechanical device, emphasizing its substantial equivalence through non-clinical performance and safety testing. It lacks the quantitative performance metrics, study design details, and specific AI/ML related information (training sets, expert ground truth, adjudication, MRMC studies) that your questions are designed to uncover for AI/ML medical devices.

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The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.

The provided text is a 510(k) Premarket Notification Summary for "The Slide," an intraoral device for snoring and obstructive sleep apnea. It outlines the device's characteristics, comparison to a predicate device (SomnoDent G2), and performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device for which such detailed performance metrics, ground truth establishment, and clinical study designs (MRMC, standalone) would be highly relevant.

The document makes it clear that clinical testing was NOT required and that substantial equivalence was based upon "benchtop performance testing" and comparison to a predicate device. This is a traditional medical device clearance, not an AI/ML device clearance that would typically involve the kind of rigorous performance evaluation against established ground truth as outlined in your request.

Therefore, many of your requested points cannot be answered from the provided text because the study type (benchtop mechanical testing, not a clinical study assessing diagnostic or therapeutic accuracy in humans based on ground truth data) does not lend itself to those questions.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as per the provided text for a mechanical device):

The "acceptance criteria" detailed in the document primarily revolve around mechanical integrity and biocompatibility, not performance metrics related to diagnostic accuracy or AI assistance.

Study Details (Based on the Provided Text):

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

   • Test Set Sample Size: Not applicable in the context of clinical data for an AI/algorithm. The performance data is primarily benchtop mechanical testing. The document states, "Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand..." No human test subjects or clinical data are described.
   • Data Provenance: Not applicable for clinical data. The context is benchtop testing of the device itself.

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

   • Not applicable. Ground truth, in the sense of expert consensus on patient conditions (e.g., diagnosis of sleep apnea from physiological data), was not established for this type of testing. The "truth" here is engineering specifications and material properties.

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

   • Not applicable. There was no clinical test set requiring adjudication.

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 study was explicitly not done. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing." This device is a physical intraoral device, not an AI-assisted diagnostic tool.

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

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

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

   • The "ground truth" for this regulatory submission was compliance with engineering standards (ISO 10993-1:2018 for biocompatibility) and achieving specific mechanical properties (withstanding force) that were deemed sufficient compared to the predicate device and expected in-mouth forces. Clinical ground truth was not part of this evaluation.

7. The sample size for the training set:

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

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

   • Not applicable. There was no training set for an AI/ML model.

In summary, the provided document details the regulatory clearance of a physical medical device (intraoral snore/sleep apnea appliance) based on engineering performance and substantial equivalence to a predicate, rather than the performance evaluation of an AI/ML diagnostic or assistive algorithm. Therefore, many of your questions regarding AI-specific criteria are not addressed by this document.

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The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Phasor™ Drill is a handheld single unit drill that is a sterile, single use device. The drill includes an ergonomically designed outer shell for ease and maneuverability, a thumbscrew drill stop to ensure the product drills to the preset required depth, and a fixed drill bit made from 440A stainless steel. The Phasor™ Drill is powered by six primary lithium CR2 cells electrically connected in series to provide 18 V. The motor used in the Phasor™ Drill is a brushed DC motor which is designed to be run from a direct current power source, via batteries. The gearbox is integrated into the motor to reduce the rotational speed. The drill bit forms the shaft of the motor eliminating the need for a coupling, chuck or other clutching mechanism. The Phasor™ Drill product family includes various drill sizes depending on the drill bit diameter (0.75-3.2 mm), number of flutes (2 or 3), drill bit length (75-210 mm), and Thumb Screw Drill stop diameters (1.5-3.2 mm). As seen in Figure 1, the Phasor™ Drill has two switches. The ON/OFF button in the front is a momentary push button switch which activates the drill when pressed. The blue slider switch on the top is used for reversing the direction of rotation. The slider switch is a DPDT (double pole; double throw) which reverses the polarity of the drill motor when moved in forward or rearward direction.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Phasor Drill. It's important to note that this document is a 510(k) summary for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical effectiveness studies with explicit acceptance criteria for diagnostic performance metric. The "acceptance criteria" here relate more to engineering performance and regulatory compliance for a mechanical device.

Acceptance Criteria and Reported Device Performance

The document describes several performance tests, but it doesn't explicitly state numerical "acceptance criteria" in the format of a typical diagnostic AI/imaging study (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted to "verify suitability of the design characteristics" and that "Results of the testing confirmed the Phasor™ meets design requirements."

Study Details

Given that this is a 510(k) for a mechanical surgical drill, the "study" described is a series of engineering and material performance tests, not a clinical trial or an AI algorithm performance study. Therefore, many of the typical questions for an AI device are not directly applicable.

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

   • Test Set Sample Size: Not explicitly stated how many devices or components were tested for each performance test (e.g., compression, torque, drill stop pull, aging). The document mentions "results from the performance testing are provided" and "All testing performed was conformal," implying sufficient samples were evaluated to ensure design requirements were met.
   • Data Provenance: Not specified. These are likely internal bench tests conducted by Biotex, Inc. or a contracted testing laboratory. The document focuses on regulatory compliance, not geographical data origin. The testing is prospective for the purpose of demonstrating device performance.

2. 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 question is not applicable as the "ground truth" for a mechanical device like a drill is related to its physical performance characteristics (e.g., torque, compression strength, sterility maintenance) which are measured by engineering standards and equipment, not by expert interpretation like in image-based diagnostic AI.

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

   • This question is not applicable for the type of engineering performance testing described. Results are based on objective physical measurements against established engineering specifications and standards.

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

   • This question is not applicable. The Phasor Drill is a mechanical surgical tool, not an AI-assisted diagnostic device. No human-in-the-loop performance or comparison with AI assistance is relevant.

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

   • This question is not applicable. The Phasor Drill is a mechanical surgical tool, not an AI algorithm. Its standalone performance is its mechanical function.

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

   • The "ground truth" here is based on engineering specifications and recognized standards for mechanical performance (e.g., torque values, pull-out forces), biocompatibility (ISO 10993 standards), and packaging integrity (ASTM standards). These standards define acceptable ranges or outcomes for the device's physical properties and sterility.

7. The sample size for the training set

   • This question is not applicable. The Phasor Drill is a mechanical device, not an AI algorithm that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not machine learning data.

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

   • This question is not applicable for the same reason as question 7.

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The PhoTex30 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck. orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The PhoTex30 Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CVV), pulsed or external modulation modes in the initialians and series provides a means. wavelengths: 980nm, 810nm, and 940nm. The PhoTexy Diode Laser Series dollygry wavelengths. 960mm, and vaporization of tissue using a compatible fiber optic delivery for cutting, coagulation, and vaporization of tiber optic delivery accessory terminated with a numerical accessory. The laser is compatible with uny hist "bptro" and one of larger with a numerical aperture of at least .37.

The provided document is a 510(k) summary for the PhoTex30 Diode Laser Series. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical or analytical testing with quantitative performance metrics.

Instead, the document states generally that "Engineering studies have demonstrated the substantial equivalence of the PhoTex30 Diode Laser Series" to predicate devices. The conclusion is that "the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information that can be extracted relates to the comparison to predicate devices and general compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document implies the acceptance criterion is "substantial equivalence" to the predicate devices (PhoTex15 Diode Laser Series (K060304) and SLT Thermalite Diode Laser Series (K952661)) in terms of "technological features, device performance, and indications for use." It also states compliance with "FDA standards 21CFR1040.10 and 21CFR1040.11."
• Reported Device Performance: "The studies concluded that the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications." However, no specific quantitative performance metrics (e.g., accuracy, precision, wavelength stability, power output consistency, etc.) are provided in the summary.

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "engineering studies" rather than a test set with data collected from human subjects or retrospective/prospective medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned are "engineering studies," not clinical or diagnostic studies requiring expert review for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 device is a surgical laser, 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: The document describes "Engineering studies" of the device itself, implying standalone performance evaluation, but without specific quantitative metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. The "ground truth" for an engineering study would be the device's adherence to design specifications and regulatory standards, evaluated through physical measurements and tests.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" through engineering studies, rather than providing detailed performance metrics from clinical or analytical studies as one might expect for a diagnostic or AI-powered device.

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The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

The Visualase Thermal Therapy System is compatible with General Electric Medical Systems Signa model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.

The Visualase Thermal Therapy System comprises four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy. A software application running on the workstation allows the workstation user to control the laser output and to operate the coolant pump from the workstation interface. Additionally, when appropriate thermal imaging guidance is used, temperature limits may be associated with prescribed image locations and used as an interlock for automatic deactivation of the laser output.

A previous version of the Visualase Thermal Therapy System has been cleared for marketing via 510(k) notification (Visualase Thermal Therapy System, K071328). The instant version of this system extends the functionality of the predicate version by providing a software interface for control of the laser output through the computer interface port of the laser component and on/off operation of the pump through a similar interface. When used with appropriate magnetic resonance thermal imaging guidance, a software tool may be used to prescribe limits for the temperature at certain points in the image which can, in turn, be used to deactivate the laser if the limits are reached. Thus this system provides an additional level of "interlock" security over the previous version which may increase safety and/or precision of the treatment prescription. It is important to note that while temperature image information can be used to automatically deactivate the laser as a safety precaution, the user may, at his discretion, override the interlock and proceed with additional laser energy deposition if warranted. Further, it is important to note that the added security feature is in no way capable of energizing the laser on its own. The laser may ONLY be activated by a deliberate action from the user. Thus the added feature serves only as an additional safety interlock on the laser system similar to many other common safety features.

Computer control of the coolant pump status (ON/OFF) provides an additional convenience to the user and also provides an additional safety feature since, when the laser is operated from the workstation interface, activation of the laser can be made dependent on first activating the coolant pump.

The addition of these features to the Visualase system has no effect on the Indications for Use statement which remains unchanged from the predicate device (except that we have now extended compatibility to Siemens MRI systems).

This 510(k) summary (K081656) describes an updated version of the Visualase Thermal Therapy System. The key purpose of the submission is to demonstrate that the new version, which adds software control for laser output and pump operation, and an additional safety interlock feature, is substantially equivalent to the previously cleared predicate device (K071328).

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or MRMC/standalone studies.

The document explicitly states under "Non-clinical Performance Tests":
"Performance, specifications, and technical data for the components of the Visualase component devices are essentially unchanged from the previous version, and are therefore not included here."

This means that the current submission relies on the performance data of the predicate device and asserts that the new features do not alter the core functionality or safety that would necessitate new performance studies against specific acceptance criteria. The enhancements are primarily focused on user convenience and an additional safety interlock, which likely fall under software validation and system integration testing rather than clinical or performance efficacy studies against pre-defined metrics regarding tissue ablation or temperature measurement accuracy.

Therefore, for the information requested in your prompt, I can only state that it is not available in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence based on unchanged indications for use and the nature of the added features.

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The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.

The Visualase Thermal Therapy System comprises four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy.

The four components have themselves been previously cleared for marketing via 510(k) notifications with the new device bringing these four components into a single portable cart for use in MR-guided laser thermal therapy procedures. In practice, all of the devices are used according to their approved indications for use. That is, the laser applicator is introduced into the tissue to be destroyed and connected to both the laser energy source and the cooling pump. The cooling pump and laser are operated as normal to deliver energy and cause tissue ablation. Since the laser applicator is MR-compatible, the laser ablation procedure may be carried out inside of an MRI magnet. In this case, appropriate MR imaging can be performed during the treatment, and the MR analysis software can be used to evaluate the thermal changes in the target tissue.

The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology typically associated with evaluating AI/software performance as requested in the prompt.

The document K071328 is a 510(k) summary for the Visualase® Thermal Therapy System, describing it as a combination of four previously cleared devices: a laser energy source, a cooled laser applicator, a pump, and MRI analysis software. The summary focuses on the substantial equivalence of this combined system to its predicate devices, emphasizing that the individual components' functions and performance remain unchanged.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. It rather states that "Performance and technical data for each of the components of the Visualase Thermal Therapy System are unchanged from those listed in the original submissions." This implies that the individual components met their respective acceptance criteria in prior 510(k) clearances, and the combination as a system is not introducing new performance parameters that require a new set of criteria.

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

Not applicable. The submission is a 510(k) for a system combination, not a new device requiring a performance study with a test set of data.

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

Not applicable. No new test set or ground truth establishment is described for this 510(k).

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 device predates the common application of AI in this context and is a combination of existing cleared components. The MR analysis software provides "passive monitoring" and "information that may be useful," but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis," indicating it's not designed for standalone diagnostic or decision-making. No MRMC study is mentioned.

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

The document indicates the Visualase MRI analysis software is for "passive monitoring" and processing "images to determine relative changes in tissue temperature during therapy." It provides "information that may be useful in the determination or assessment of thermal therapy" but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis." This suggests it is not intended for standalone decision-making, and no standalone performance study is mentioned.

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

Not applicable. There is no new performance study described in this 510(k) that would require establishing a ground truth for a test set. The individual components would have had their own validation data during their initial clearances.

8. The sample size for the training set:

Not applicable. The document describes a combination of existing cleared devices. There is no mention of a new "training set" for the MRI analysis software in this context. The software processes images based on physical principles (proton resonance-frequency shift analysis), not machine learning requiring a training set in the modern sense.

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

Not applicable. See point 8.

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The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.

The Visualase ENVISION platform consists of a PC-based Linux workstation running the ENVISION software tools in an X-windows environment. The device uses a standard Ethernet connection to retrieve image data files from a compatible MRI scanner host. The images may be retrieved as soon as they have been stored on the MRI host, facilitating near real-time analysis of dynamic MRI data.

The Visualase ENVISION software tools perform three primary functions: 1) Image transport, 2) Image processing, and 3) Data display. The Image transport tools negotiate communication with the MRI scanner host, determine the availability of images, facilitate retrieval of image files, facilitate local storage of image files, and notify Image processing tools of new data. The Image processing tools extract relevant data from available MR images and update data analysis information. The Data display tools provide visualization and facilitate manipulation of the data extracted by the Image processing tools.

Data may be processed to display dynamic changes in voxel intensity as a function of image acquisition. Such analysis is useful in analyzing the uptake and washout of MR contrast agents and can be useful for discrimination of tissue type or state. When data from compatible sequences is available, images may also be processed to extract the complex phase angle of voxels as a function of image acquisition. Using proton-resonance-frequency (PRF) shift analysis and image subtraction, changes in complex phase angle may be related back to relative changes in temperature during the study.

The Visualase ENVISION software is compatible with General Electric Signa model MR scanners and can be configured to operate with either LX or EXCITE format images.

The provided 510(k) summary for the K063505 Visualase ENVISION Software System does not contain detailed acceptance criteria or a dedicated study section proving the device meets specific acceptance criteria.

The document discusses the device's technical performance in terms of computation and artifact handling, and asserts substantial equivalence to a predicate device. However, it does not present a formal study with defined acceptance criteria and reported numerical results in the way that would typically be expected for a detailed performance study.

Based on the provided text, here’s a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the 510(k) summary. The document describes how the device handles data and potential artifacts, but not specific quantifiable performance metrics with defined thresholds that the device was tested against.

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. There is no mention of a specific test set or data used for performance validation.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the 510(k) summary, as there's no mention of a study involving expert-established ground truth.

4. Adjudication Method

This information is not provided in the 510(k) summary, as there's no mention of a study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not discussed or presented in the 510(k) summary. The document focuses on the device's technical capabilities and its similarity to a predicate device, not on how human readers' performance is affected by using the device.

6. Standalone (Algorithm Only) Performance Study

While the document describes the software's functions in detail, an explicit standalone performance study with quantifiable metrics like sensitivity, specificity, accuracy, etc., is not presented. The "Technical Performance" section describes data handling and artifact mitigation, which are aspects of standalone performance, but not a formal study with results against specific criteria.

7. Type of Ground Truth Used

This information is not provided, as there is no mention of a formal study utilizing ground truth.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not discuss any machine learning or AI components that would typically involve a training set.

9. How Ground Truth for the Training Set Was Established

This information is not provided, as there is no mention of a training set or its associated ground truth establishment.

Summary of what is available from the document regarding "performance":

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems: Advantage Windows Workstation with FuncTool option K960265) based on:

• Design: PC-based Linux workstation, X-windows environment, standard Ethernet connection to MRI scanner.
• Technical Performance (qualitative descriptions):
  • Computation: Uses 32-bit float or integer, converts to lossless XPM format for display/transfer, re-computes output images from original data to prevent data loss, 16 bits-per-pixel depth input, 32-bits deep representations for computation.
  • Artifacts: Minimizes "phase breaks" in phase difference images by using real and imaginary MR images as inputs and full complex-phase-difference implementation. Mentions potential causes of artifacts (long echo times, patient motion) and general MRI best practices to minimize them.
• Indications for Use: Ability to retrieve, store, process, and display temporally dynamic MR data for analyzing intensity changes (e.g., contrast enhancement) or phase changes (e.g., temperature, angiography).

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive de novo clinical or performance studies with predefined acceptance criteria for every new feature, especially for image processing software that provides information for a trained physician to interpret. The FDA's letter confirms that the device was found substantially equivalent to the predicate.

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The PhoTex15 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including; gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The PhoTexys Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW) or pulsed-mode in the infrared range at one of the following wavelengths: 980nm, 810nm, and 940nm. The PhoTexis Diode Laser Series provides a means for cutting, coagulation, and vaporization of tissue using a compatible fiber optic delivery accessory. The laser is compatible with any fiber optic delivery accessory terminated with a standard SMA905 connector whose core fiber diameter is 400 micron or larger with a numerical aperture of at least .37.

This document is a 510(k) summary for the BioTex PhoTex₁₅ Diode Laser Series, seeking substantial equivalence to predicate devices. It does not describe a study involving acceptance criteria and device performance in the context of AI/ML or diagnostic accuracy.

Instead, it pertains to a traditional medical device (a laser) and its compliance with FDA standards and comparison to existing similar devices. Therefore, I cannot extract information related to AI/ML specific criteria such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.

Here's an analysis based on the provided text, focusing on the traditional device context:

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

The document does not explicitly state acceptance criteria in a quantitative table format that would be typical for performance studies to determine accuracy or sensitivity/specificity. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on design, technological features, device performance (in a general sense), and indications for use.

The "performance" described is that the lasers:

• "functioned and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications."
• "are in compliance with FDA standards 21CFR1040,10 and 21CFR1040.11."

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. This is not a study involving a "test set" of patient data for evaluating a diagnostic or AI/ML device. The evaluation was based on "Engineering studies" and comparison of technical specifications.

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 was no "ground truth" derived from expert review of a test set in the context of diagnostic performance.

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

Not applicable for the same reasons as above.

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 not a diagnostic device involving human readers or AI assistance.

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

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

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

Not applicable. The "ground truth" here is compliance with established safety and performance standards for laser devices and the technical specifications of predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable.

Summary of the traditional device evaluation:

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices (SLT Thermalite Diode Laser Series and PhotoMedex LaserPro Diode Laser Systems) in terms of:
  • Technological features
  • Device performance (general functionality and safety)
  • Indications for use
  • Compliance with FDA standards 21CFR1040,10 and 21CFR1040.11.
• Reported Device Performance: The PhoTex₁₅ Diode Laser Series "functioned and performed in a manner similar to the predicate device" and is "in compliance with FDA standards."
• Study Proving Compliance: "Engineering studies have demonstrated the substantial equivalence" to the predicate device. These studies concluded that "no significant differences exist" and "differences were determined to be minor and are each within the specifications listed by the predicate device."
• Study Type: Non-clinical (benched-based) engineering tests and comparison of specifications to predicate devices.

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The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF),

The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.

The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or noncontact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.

The VCLAS family consists of three components, the LDF, CCS, and BTF. The LDF and BTF transmit laser energy to the tissue situated at their distal regions. The LDF is comprised of a standard silica fiber optic cable affixed with a diffusing tip assembly. The diffusing tip assembly is comprised of a plastic tube that is filled with a transparent matrix in which light dispersing particles are embedded. The distal end of the tube is sealed with a higher concentration of scattering particles in a conical structure to prevent significant forward transmission of energy.

The LDF may be used with a cooling catheter, in particular the compatible CCS, but such a catheter is not required. The CCS can be employed with or without coolant flow. The use of coolant provides cooling for the surfaces of the CCS in contact with both the tissue and the LDF.

The BTF is comprised of a standard silica fiber optic cable identical to fiber optic used in the LDF. The distal end of the BTF is terminated in a flat, polished face and is designed for use in both contact and non-contact applications.

The provided 510(k) summary describes the Visualase Cooled Laser Application System (VCLAS), which includes the Laser Diffusing Fiber (LDF), Cooling Catheter System (CCS), and Bare Tip Fiber (BTF). This submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the document does not contain information on acceptance criteria in the typical sense of performance metrics for a diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs similarly to predicate devices and is safe for its intended use.

Here's an analysis based on the provided text, aligning with your request as much as possible, interpreting "acceptance criteria" through the lens of substantial equivalence:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity or specificity) for new clinical claims. Instead, the "acceptance criteria" are met by demonstrating:

• Functional Equivalence: The device performs its intended function (e.g., tissue coagulation/necrosis for LDF/CCS, vaporization/cutting/ablation/coagulation for BTF) in a manner similar to predicate devices.
• Biocompatibility: Materials used are safe for human contact.
• Safety: No new safety concerns are raised compared to predicate devices.

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

The document refers to "engineering studies" and "non-clinical performance tests." It does not specify:

• Sample size: The number of fibers, catheteters, or tissues tested.
• Data provenance: The country of origin or whether the data was retrospective or prospective. Given these are engineering studies, they are likely controlled laboratory experiments rather than human clinical data.

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 provided in the document. Given the nature of the studies as "engineering studies" for a physical device, expert review (e.g., by radiologists or pathologists) for ground truth as would be common for diagnostic AI/imaging devices is not described. The assessment likely relied on physical measurements and observations of coagulation effects from the engineering studies themselves.

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

This information is not provided in the document. Adjudication methods are typically relevant for human-interpreted data (e.g., medical images), which is not the primary focus of the described "engineering studies."

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a laser fiber and catheter system. The submission is for a physical medical device (laser accessories), not an AI algorithm.

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

Not applicable. The device is a physical medical instrument (laser fiber and catheter system), not a standalone algorithm.

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

For the "engineering studies" that concluded "the treated tissue displayed an ellipsoidal coagulation area," the "ground truth" would be the observed physical effect on the tissue (e.g., lesion size, shape, and characteristics), likely measured directly or via histological analysis in a laboratory setting. The document does not specify how this "ground truth" (i.e., the observed tissue effects) was established or by whom.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not an AI algorithm requiring a training set.

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

Not applicable. As above, this device is a physical instrument, not an AI algorithm requiring a training set and associated ground truth.

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