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The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.

This document describes a 510(k) premarket notification for the Hysteroscopy Pump HM6. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical studies with acceptance criteria. Therefore, the information provided is primarily focused on demonstrating the similarity of the new device to existing devices on the market, relying on bench testing for performance.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the "performance testing" section refers to bench tests and compliance with standards. The key "acceptance criterion" for this 510(k) submission is showing that the device is substantially equivalent to predicate devices and that the modifications do not raise new questions of safety and effectiveness.

The document highlights the following performance aspects and their comparison to the predicate Aquilex System:

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The Aquilex Fluid Control System H112 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Aquilex Fluid Control System H112 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a special roller stand. The irrigation pump unit is a single roller pump that functions according to the peristaltic system. It is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit. Strict fluid intake and output surveillance is therefore ensured during the entire procedure.

The Aquilex Fluid Control System H112 is a medical device intended to provide liquid distension of the uterus during hysteroscopy and monitor fluid differential. The provided document details the 510(k) premarket notification for this device, comparing it to predicate devices to demonstrate substantial equivalence rather than presenting an exhaustive de novo clinical study with specific acceptance criteria that one would find for an AI/ML device.

However, based on the performance testing section, we can infer the acceptance criteria and reported device performance from the bench testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance

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The 45L CORE Insufflator F114 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

The 45L CORE Insufflator F114 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application, a bariatric application and a vessel harvesting application. The device incorporates the following major components and features: a casing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting symbols and display elements. The device is equipped with a continuous pressure measurement mode and redundant discontinuos pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 45L CORE Insufflator F114 is designed with several alarms to inform the operator in case of an overpressure. The device is to be used with specially designed single-use tubing sets.

The 45L CORE Insufflator F114 is a medical device used for laparoscopic and endoscopic procedures. The information provided outlines its substantial equivalence to predicate devices rather than a detailed study with specific acceptance criteria and performance data in a tabular format. However, based on the text, we can infer the aspects that were evaluated for substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a formal table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices (40 L High Flow Insufflator F113, HI-FLO Therme Pneu 45, Stryker Heated Insufflator Tube Set, Surgiflator 20). The "acceptance criteria" are implied to be that the new device does not raise new questions of safety and effectiveness compared to these predicates, and that its performance is equivalent or similar enough not to warrant additional concerns.

From the text, we can glean the following comparisons and performance claims:

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

The document states "Bench testing demonstrates the safety and effectiveness of the F114." It does not provide specific details on the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Typically, "bench testing" would imply laboratory-based tests on manufactured units, rather than human, animal, or clinical data.

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

This information is not provided. Given that the submission focuses on substantial equivalence via bench testing and comparison to predicate devices, there's no mention of a ground truth established by experts in the context of clinical performance or diagnostic accuracy.

4. Adjudication method for the test set

This information is not provided. As above, for bench testing, an adjudication method for ground truth (which is relevant for perceptual or diagnostic tasks) would typically not be 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

There is no mention of an MRMC study. This device is an insufflator, a mechanical device, not an imaging analysis or AI-driven diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its function.

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

This concept is not applicable to an insufflator device. It is a piece of medical equipment used by a human operator, not an algorithm that performs a task autonomously.

7. The type of ground truth used

For the performance assessment, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, EN), and the established performance of the predicate devices. For example, for sterilization, the ground truth is a specific sterility assurance level (SAL) and residual gas limits. For pressure output, the ground truth would be the specified pressure ranges and stability. It's based on objective, measurable physical parameters.

8. The sample size for the training set

This information is not provided and is not applicable in the context of a purely hardware device like an insufflator. Training sets are relevant for machine learning algorithms.

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

This information is not provided and is not applicable for the reasons mentioned above.

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The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is a microprocessor controlled single roller pump, which functions according to the peristaltic system. The device incorporates the following major components and features: a casing, a world power supply, a rechargeable battery pack, a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control. The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure.

The provided text is a 510(k) summary for a medical device called the FLOSIMPLE Arthroscopy Pump A120. It details the device's function, intended use, and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or machine learning performance metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a ground truth or expert review for performance testing in the context of AI.
• Adjudication method: Not applicable.
• 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, as this is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety profiles, rather than presenting a performance study against specific acceptance criteria in the way one would for a new diagnostic algorithm.

The key points of the submission are:

• Device Name: FLOSIMPLE Arthroscopy Pump A120
• Intended Use: To provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.
• Predicate Devices: Arthroscopy Pump A107 (K030402), Arthro-Surgimat-A103 (K000153), Arthro-Surgimat-1500 (K983910), Lap-Wave 3000 (K990732).
• Argument for Substantial Equivalence: The A120 shares the same intended use and fundamental function (peristaltic system) with its predicates. Technological differences are described as minor (e.g., casing modification, new cartridge, preselectable pressure/flow levels, rechargeable battery, touch screen, single roller pump, single pressure sensor vs. redundant) and are argued not to raise new questions of safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (an arthroscopy pump), not an AI/ML-driven diagnostic or assistive device. Therefore, the questions related to AI performance metrics, sample sizes for training/test sets, ground truth establishment, and multi-reader studies are not applicable to the content provided.

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The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

The 40 L High Flow Insufflator F113 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application and a vessel harvesting application. The device incorporates the following major components and features: a housing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting keys and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 40 L High Flow Insufflator F113 is designed with several alarms to inform the operator in case of an overpressure. The device may be used with a heating tube and with an optional remote control.

The provided text describes the 40 L High Flow Insufflator F113 and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a detailed study of device performance against such criteria. The document is a 510(k) summary for a medical device and therefore focuses on establishing substantial equivalence rather than presenting an exhaustive performance study with acceptance criteria.

However, based on the information provided, we can infer some aspects related to performance and how "evidence" was presented for regulatory purposes.

Here's a breakdown of the requested information, with sections noted as "Not Provided" when the information is missing from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence, meaning the new device performs similarly and is as safe and effective as existing legally marketed devices. It does not provide specific quantitative acceptance criteria (e.g., "pressure maintained within X% of set point for Y time") or detailed results of performance testing against such criteria.

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

• Sample Size for Test Set: Not Provided. The document mentions "performance testing" and a "clinical evaluation," but no specific sample sizes for these tests are given.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not Provided. The clinical evaluation includes a "summary of peer reviewed literature and information on questionnaire results." The origin or nature (retrospective/prospective) of this data is not specified.

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

• Not Provided. The document mentions a "clinical evaluation" and "questionnaire results," but it does not specify the number or qualifications of experts involved in establishing ground truth for any test set. Given the nature of a CO2 insufflator, "ground truth" might pertain to objective measurements of pressure regulation or flow rather than expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

• Not Provided. No mention of an adjudication method is included in the summary.

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 such study was done. This device (a CO2 insufflator) is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in a diagnostic context. Therefore, an MRMC study or AI-related effectiveness measure is not applicable.

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

• Not Applicable. This device is a hardware insufflator and does not involve algorithms for standalone diagnostic performance. Its function is to facilitate endoscopic procedures by distending cavities with gas.

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

• Not explicitly stated in detail. For a CO2 insufflator, "ground truth" would likely involve objective physical measurements like pressure, flow rate, and CO2 concentration, as well as operational safety parameters. The "performance testing" mentioned generally refers to these kinds of engineering and functional tests. The "clinical evaluation" would likely focus on the intended use and safety in a surgical context, possibly drawing upon outcomes data from the peer-reviewed literature.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is a hardware product, not a machine learning model, so there is no "training set" in the conventional sense of AI/ML. For hardware, "training" might refer to testing under various conditions, but no specific "training set" size for data used to optimize hardware design is provided or relevant in this context.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve visibility of the surgical field during urologic procedures.

The URO Pro is a microprocessor controlled pump which functions according to the peristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensor monitoring ensures the conformity of the preset nominal pressure value with the actual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.

The provided text is a 510(k) summary for the URO Pro device, which is an irrigation roller pump. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards. It does not contain information about specific acceptance criteria related to device performance in a clinical or simulated clinical setting, nor does it describe a study that proves the device meets such criteria in terms of efficacy or diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be answered from the provided document.

However, I can extract the information that is present:

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

The following information is NOT available in the provided text:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a test set or its provenance is given. The "Performance Data" section refers to compliance with safety standards, not clinical performance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information about experts or ground truth establishment for a test set is provided.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set performance 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 device is an irrigation pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant and not mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical performance study requiring ground truth is described.
• 8. The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
• 9. How the ground truth for the training set was established: Not applicable.

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The 40L High Flow Insufflator F108 with low flow mode is a device intended to facilitate the use of the laparosoope by filling the peritoneal cavity with gas to distend it. The low flow application of this device is indicated for pediatric use.

The 40 L High Flow Insufflator F108 is a microprocessor controlled device designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and therapeutic laparoscopic procedures. The 40 L High Flow Insufflator F108 consists of the following main components: a housing, power supply, pressure reducers, a venting system, a fluid sensor, a gas heater, various setting kevs and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the abdomen with the pre-set nominal pressure. The device is to be used with a specially designed heating tube and with an optional remote control.

The 40 L High Flow Insufflator F108 is a medical device and therefore does not have acceptance criteria or performance metrics directly comparable to AI/ML software. The provided text describes its regulatory submission (510(k)) and substantial equivalence to a predicate device, rather than a study with acceptance criteria for device performance in the way an AI model would be evaluated.

Here's a breakdown of the specific points you requested, based on the provided document:

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

This information is not applicable in the context of this medical device submission. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing new acceptance criteria for novel performance metrics with a quantitative study design.

However, the document states:

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device, Surgiflator 40 (K001533), in intended use, design, and technological characteristics. The main difference, a new software logarithm for accurate flow measurements (0.1 V/min to 1 V/min) and a Low Flow Mode, was deemed not to raise new questions of safety and effectiveness.
• Reported Device Performance: "Bench tests demonstrate the safety and effectiveness of the 40 L High Flow Insufflator F108 when used in the Low Flow Mode to insufflate small abdominal cavities." No specific quantitative performance metrics are provided in the summary.

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 test set or data provenance is mentioned as this is a medical device for which bench testing was performed, not a data-driven AI/ML model.

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 experts are mentioned in the context of establishing ground truth for a test set. Bench tests were performed to demonstrate safety and effectiveness.

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

Not applicable. No adjudication method is mentioned as no test set requiring human adjudication was utilized.

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. No MRMC comparative effectiveness study was performed or mentioned. This is a hardware medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a standalone hardware product. The mention of "software logarithm" refers to an internal control system for accurate flow measurements, not an AI algorithm for diagnostic interpretation or decision-making. Its performance is its standalone performance without a human in the loop for its primary function of insufflation.

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

Not applicable in the sense of a data-driven model. The "ground truth" for this device's safety and effectiveness was established through bench tests and a comparison to the predicate device's known performance record and literature review on CO2 insufflators.

8. The sample size for the training set

Not applicable. No training set is mentioned. This device does not use machine learning in the conventional sense that would require a training set.

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

Not applicable. No training set was used.

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The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

The Arthroscopy Pump A115 is a microprocessor controlled single roller pump designed to provide fluid distention and irrigation of joint cavities during diagnostic and operative arthroscopy. The pump functions according to the peristaltic principle and consists of the following main components: a housing, a power supply, a roller wheel, a pump head, various setting keys and display elements. The pump is used with special designed irrigation tubings, a pressure remove control and a foot pedal. A constant performed redundant pressure control assures conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

This medical device is an "Arthroscopy Pump" rather than an AI/ML device, so the requested information (acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, training set size, etc.) is not applicable in the context of the provided documentation.

The 510(k) summary for the Arthroscopy Pump A115 explicitly states:

VIII. Performance/Clinical Data:
"No performace or clinical data is provided."

Therefore, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed AI/ML specific questions. The submission primarily relies on substantial equivalence to predicate devices (other arthroscopy pumps) and compliance with voluntary standards for electrical safety and electromagnetic compatibility.

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The W.O.M. Laser U100plus is intended for use in endoscopic surgical procedures to fragment stones. The W.O.M. Laser U100plus is indicated for use to fragment urinary stones (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.

The W.O.M. Laser U100plus is an intracorporal laser lithotripter in Urology and Gastroenterology. It transmits pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone. The device incorporates an internal water cooling cycle with a water-air heat exchanger system. It provides safety features and displays parameters on the operator panel. Differences from the predicate W.O.M. Laser U100 include a minor increase in pulse energy and pulse frequency, and the option of a double pulse setting.

The provided text describes a 510(k) submission for the W.O.M. Laser U100plus, a device intended for stone fragmentation. However, it does not explicitly state acceptance criteria in a table format with specific performance metrics (e.g., success rates, fragmentation times) that the device must meet.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technical characteristics, and safety/effectiveness data. The "study" mentioned isn't a performance study with defined quantitative acceptance criteria and results against those criteria, but rather a general statement about supporting data.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not available:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document describes compliance with standards and comparative statements regarding predicates, which function as "acceptance criteria" within the context of a 510(k) summary focused on substantial equivalence. It does not provide specific quantitative benchmarks or thresholds for performance (e.g., "95% stone clearance rate").

Study Details

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

   • Sample Size: Not specified. The document broadly states "In vitro, in vivo and clinical data has been provided." No specific number of cases or samples for these studies is mentioned.
   • Data Provenance: Not specified (e.g., country of origin). The document does not indicate whether data was retrospective or prospective.

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

   • Not specified. The document does not describe the establishment of a "ground truth" using experts for a test set, as would be common in an AI evaluation. Instead, the studies referred to are to demonstrate safety and efficacy of a medical device.

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

   • Not applicable. This concept typically applies to studies involving human readers and interpretation of data (e.g., imaging studies) where adjudicated ground truth is established. The document describes studies on a laser lithotripter, not an interpretive AI system.

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:

   • Not applicable. This is not an AI device or an imaging interpretation system. The device is a surgical laser, and the studies described are related to its direct physical performance.

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

   • Not applicable. This is not an algorithm or AI system. The device itself is a standalone medical instrument. The "study" refers to the performance of the device itself in in vitro, in vivo, and clinical settings.

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

   • The concept of "ground truth" in the AI sense is not directly applicable here. The "truth" being established in the in vitro, in vivo, and clinical studies would likely relate to objective measurements of stone fragmentation, safety parameters (e.g., tissue damage), and clinical outcomes relevant to the device's intended use. Specific details on how effectiveness (e.g., successful fragmentation) was measured or validated are not provided in this summary.

7. The sample size for the training set:

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

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

   • Not applicable, as there is no training set for an AI model.

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The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.

The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.

The provided document is a 510(k) summary for the Uropower device, a urine flow and volume measuring system. It describes the device, its intended use, and its classification. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria, and therefore I am unable to populate the table and other requested information.

The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against predefined acceptance criteria. This is common for 510(k) submissions, which often rely on comparison to existing legally marketed devices rather than de novo clinical trials with explicit acceptance criteria.

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