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The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

The UROMAT E.A.S.I. is a peristaltic (double roller), microprocessor controlled, irrigation and suction pump with continuous fluid flow for urological interventions. Alternatively, the two pumps can be flowoperated independently of each other for flow regulation, e.g., for laparoscopic interventions.

The provided text is a 510(k) summary for the Karl Storz UROMAT E.A.S.I. device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria and the rigorous study design typically associated with proving a device meets those criteria for an AI/ML or diagnostic device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm. The "Performance Data" section solely lists non-clinical testing for electrical safety, EMC, software verification/validation, usability, and biocompatibility/sterilization for tubing sets.
• Sample size, data provenance, number of experts, adjudication methods, or ground truth details for a test set. This is because no such study (e.g., relating to diagnostic accuracy, image analysis, or AI assistance) is described.
• Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance. The device is an irrigation and suction pump, not a diagnostic imaging device or an AI application.
• Training set details (sample size, ground truth establishment). As it's not an AI device, there's no mention of a training set.

Summary of what is present in the document relevant to device performance (but not in the requested format for an AI/ML device):

The document details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. Key performance parameters listed are:

• Irrigation Pressure: 20-200 mm Hg for Continuous Flow (CF), Single Flow (SF)
• Irrigation Flow: 10-250 ml/min for Continuous Flow (CF)
• Suction Flow: 100-1800 ml/min for Suction/Irrigation and Lithotripsy
• Overpressure Safety: Software prevents pressure over 200 mm Hg (hardcode); Hardware alarm at >240 mm Hg.

These are functional specifications and safety features, not acceptance criteria for an AI/ML performance study as implied by your request.

Conclusion based on the provided text:

The information in the 510(k) summary (K162992) for the Karl Storz UROMAT E.A.S.I. pertains to a fluid management device (irrigation and suction pump). It focuses on demonstrating substantial equivalence to predicate devices through technical specifications and basic non-clinical testing. It does not describe an AI/ML component or a study to prove meeting acceptance criteria for such a component, therefore, it cannot provide the requested details about acceptance criteria, test sets, expert adjudication, or AI model performance studies.

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The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.

The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.

The provided 510(k) submission for the AMSure® Bladder Irrigation Set (K070873) describes a medical device and its non-clinical testing for safety and effectiveness. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/algorithm-driven device, nor does it detail a study that proves the device meets such criteria in the context of AI.

The information provided confirms that the AMSure® Bladder Irrigation Set is a urological irrigation system, and its submission indicates performance and biocompatibility testing were conducted. However, these tests are typical for a physical medical device and do not involve AI, machine learning, or software-driven diagnostic capabilities. Therefore, many of the questions regarding AI/algorithm performance, ground truth, expert review, and reader studies are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document and why certain sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Performance and biocompatibility testing have demonstrated that the AMSure® Bladder Irrigation System is safe and effective for its intended use." However, it does not provide a table of specific acceptance criteria (e.g., fluid flow rates, pressure limits, material strength, sterility, etc.) or the quantitative results of these performance tests.

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

Not applicable. This is a physical medical device, not an AI/algorithm. Performance testing would involve physical samples of the irrigation sets, not 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. Ground truth, in the context of AI, refers to expert-validated labels for data. This device does not generate diagnostic outputs that require expert ground truth labeling.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in AI performance studies to resolve discrepancies in expert labeling or model outputs, which is not relevant here.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. There are no "human readers" interpreting data with or without AI assistance for this product.

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

Not applicable. There is no algorithm for this physical device that operates in a standalone capacity.

7. The type of ground truth used

Not applicable. As there's no AI/algorithm generating outputs to be evaluated against a ground truth, this concept doesn't apply. The "truth" for this device would be its physical properties and function meeting predefined engineering specifications and biological safety standards (e.g., non-toxic materials, sterile packaging).

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the AI sense.

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

Not applicable. No AI training set.

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To provide irrigation during endoscopic surgical procedures

Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.

Here's an analysis of the provided text regarding the Spyglass Irrigation System's acceptance criteria and study, structured to address your specific points:

The provided 510(k) summary for the Spyglass Irrigation System offers very little detail regarding specific acceptance criteria or a comprehensive study demonstrating direct performance against those criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• System Components
• Flow rate adjustments
• Min/max flow rate
• Min/max Pressures
• Pump Type |

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

• Sample Size for Test Set: Not mentioned. The document only states "Bench testing was performed." It doesn't specify if this involved multiple devices, repeated trials, or a representative sample.
• Data Provenance: Not mentioned. Given the nature of a 510(k) submission and "bench testing," it's highly likely to be internal R&D data from the manufacturer (Medical Scientific Corporation) in the USA. It is prospective testing, as it's for premarket notification.

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

• Not applicable/Not mentioned. The testing described is "bench testing," which typically involves objective measurements by engineers or technicians against specifications, rather than expert judgment for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The described testing is bench testing, which doesn't involve this type of adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document focuses on technical bench testing and comparison to a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an irrigation pump, not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Yes, in a sense, a standalone evaluation was performed through "bench testing." This type of testing assesses the device's technical specifications and functionality independent of direct human operational variables beyond standard use. However, it's not an "algorithm only" study as the device is mechanical/electronic, not AI-driven.

7. Type of Ground Truth Used

• Bench Test Specifications/Predicate Device Data: The ground truth for the bench testing would be the pre-defined technical specifications for flow rate, pressure, and operational parameters, often benchmarked against the predicate device's known performance characteristics.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. The Spyglass Irrigation System is a medical device, not an AI/machine learning algorithm, so it doesn't have a "training set" in the conventional sense of data used to train a model.

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

• Not applicable. As there's no training set for this type of device, no ground truth needed to be established for it.

Summary of Study limitations based on the provided text:

The provided document (a 510(k) summary) is very high-level and intentionally brief. It aims to demonstrate substantial equivalence, not to provide a detailed report of all validation testing. Key information regarding specific performance metrics, the methodology of the "bench testing," sample sizes, and detailed acceptance criteria are omitted for brevity in this public summary. Such details would be present in the full 510(k) submission, which is not publicly available in this format.

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To provide irrigation during endoscopic surgical procedures

Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.

The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data for the SpyGlass Irrigation System.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance study details as might be found in a full clinical trial report or engineering validation document.

Here's what can be extracted and what is missing based on your template:

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

Missing: Specific numerical values for flow rate ranges, pressure ranges, or other quantifiable performance metrics are not detailed in this summary. The acceptance criteria essentially appear to be "substantially equivalent to the predicate device" in these identified characteristics.

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

Missing. The document only states "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended." It does not describe any specific test set, sample size, or data provenance.

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)

Missing. No information on expert involvement or ground truth establishment is provided.

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

Missing. No information on adjudication methods is provided.

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

Not Applicable. This device is an irrigation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

Not Applicable. This is a hardware irrigation system, not a software algorithm.

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

Missing. The concept of "ground truth" as typically applied to AI or diagnostic studies is not directly applicable or discussed for this irrigation hardware device. Performance would likely be evaluated against engineering specifications and predicate device performance.

8. The sample size for the training set

Missing. No training set is mentioned as this is a hardware device, not a machine learning model.

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

Not Applicable. See point 8.

Summary of the Study (Based on the Provided Text):

The document submitted for the SpyGlass Irrigation System (K063700) is a 510(k) summary. The primary "study" or justification presented is a comparison of technological characteristics to demonstrate substantial equivalence to predicate devices (Endogator Endoscopy Irrigation Pump - K060962, K031773).

The comparison covered:

• Intended Use
• System Components
• Flow rate adjustments
• Minimum/maximum Pressures
• Pump Type

The statement "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended" indicates that some internal testing was conducted, but the details of this testing (e.g., methodology, results, data, sample sizes, specific acceptance criteria beyond "performs as intended") are not included in this public 510(k) summary. The FDA's letter confirms that based on the information provided, the device was found substantially equivalent to predicate devices.

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The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Not Found

This looks like a 510(k) clearance letter from the FDA for a medical device called the "Nexus Irrigation Tubing Set." The letter is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization, but it does not detail the technical studies that would typically include acceptance criteria and performance data.

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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 device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kosin Technologies, LLC Piggyback Irrigating System:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating comparable performance and characteristics to the predicate device, the C.R. Bard Syringe Assist Irrigation System.

The table below summarizes the key comparative performance aspects mentioned in the document:

2. Intermittent by depressing plunger | 1. Continuous by gravity
3. Intermittent by depressing plunger |
   | Flow Rate (4-foot head height) | 9.8 L/hr | 14.7 L/hr |
   | Flow Rate (6-foot head height) | 12.0 L/hr | 17.8 L/hr |
   | Flow Rate (6-foot head height with pressure cuff) | 14.4 L/hr | 22.9 L/hr |
   | Plunger Activation Force | 0.76 lbf | 3.99 lbf |
   | Single Use Only | Single Use | Single Use |
   | Biocompatibility | Cytotoxicity, Sensitization, Irritation, Systemic Toxicity | Same (Implies similar satisfactory results) |
   | Sterilization Method | Gamma | EtO |

Note on "Acceptance Criteria": In a 510(k) for substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device by having similar technological characteristics and performance, or that any differences do not raise new questions of safety or effectiveness. The document highlights the differences in flow rate and plunger activation force, implying that these differences were deemed acceptable by the FDA for the device to be substantially equivalent.

Study Details

The provided document describes a comparative performance testing study.

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

   • Test Set Sample Size: The document does not explicitly state the sample size (e.g., number of devices tested, number of measurements taken for flow rate or plunger activation).
   • Data Provenance: The data is generated from "comparative performance testing" between the proposed and predicate devices. No information is provided regarding the country of origin or whether it was retrospective or prospective, but it implies a prospective lab-based testing scenario.

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

   • This type of performance testing (flow rate, plunger force, biocompatibility) typically does not involve human experts establishing "ground truth" in the way a clinical study or diagnostic imaging study would. The ground truth for characteristics like flow rate and activation force is established by objective physical measurements using calibrated equipment.
   • For biocompatibility, the tests are performed according to established standards, and the results are interpreted against those standards, which are based on expert consensus in toxicology and materials science, but individual experts are not adjudicating cases.

3. Adjudication method for the test set:

   • Not applicable. The study involves objective measurements and standard biocompatibility tests, not subjective interpretations 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. This is a physical performance comparison between two medical devices, not an AI-assisted diagnostic study. Therefore, an MRMC comparative effectiveness study is not relevant here.

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 device.

6. The type of ground truth used:

   • For physical characteristics (flow rate, plunger activation), the ground truth is derived from objective, quantitative physical measurements using scientific instruments.
   • For biocompatibility, the ground truth is established through standardized in vitro and in vivo testing that assesses cellular responses, sensitization, irritation, and systemic toxicity against accepted safety profiles for medical device materials.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device 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 this device.

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This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

The International Medsurg Connections Irrigation Sets.

This is a 510(k) premarket notification for a medical device (Irrigation Sets), not an AI/ML device. Therefore, the questions related to AI/ML performance, ground truth, expert adjudication, and training/test sets are not applicable.

The document describes the device's characteristics and its substantial equivalence to a predicate device based on intended use, configurations, and materials. It also outlines a summary of testing conducted to ensure the materials and components meet certain standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of evaluations performed on the "Joined Tubing 5" and 20"" and "Irrigation Sets*". These can be considered the acceptance criteria for material and component properties. The document states that "All materials used in the fabrication... were evaluated for" these characteristics, implying they met specified acceptance levels, although the specific performance values or pass/fail thresholds are not detailed in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the context of AI/ML evaluation. The "testing" refers to material and component evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, and no "ground truth" for diagnostic or predictive performance is being established.

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 an irrigation set, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be engineering specifications and material standards.

8. The sample size for the training set: Not applicable.

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

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Ask a specific question about this device