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The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley®) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).

The Accuryn Monitoring System consists of three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, and the Accuryn Monitor.

The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable (12F, 14F, and 16 F), two-way silicone urinary bladder catheter with two opposing drainage eyes and four lumens. The first lumen is for urine drainage, the second lumen for the retention balloon, the third lumen embedded with a thermistor, and the fourth lumen to measure intra-abdominal pressure (IAP).

The Accuryn SmartFoley® comes in three configurations:

• IAP, U/O, Temp (intra-abdominal pressure, urine output, and core temperature)
• U/O. Temp (urine output and core temperature) ●
• Adapter (that is compatible with commercially available Foley catheters between 6-24Fr)

The Accuryn Urine Collection Set is provided permanently pre-connected to the Accuryn Sensing Urinary Catheter's drainage lumen conveys urine to a urine measurement cassette. which connects to the Accuryn Monitor. The cassette feeds the urine collection bag. Potrero Medical also provides a configuration of the Accuryn Urine Collection Set that is not provided pre-connected to the catheter/foley. It is known as Accuryn SmartFoley Adapter and enables the user to connect a Foley catheter of their choice to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set and Accuryn SmartFoley Adapter function in conjunction with the Accuryn Monitor to measure and display urine output is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).

The Accuryn Monitor is a portable electronic device which maintains urine flow from the foley through the Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, measures the urine output volume in the measurement cassette, and displays the urine output. The Accuryn Monitor also measures and displays the temperature from the thermistor and intra-abdominal pressure (IAP) from the pressure lumen. The monitor contains software.

The provided text is a 510(k) summary for the Accuryn Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against pre-defined acceptance criteria in the manner of a novel device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/ML medical device (like MRMC studies, detailed ground truth establishment, training set provenance, etc.) is largely not present in this type of submission.

The "acceptance criteria" here are essentially that the new device configurations (smaller catheter sizes) perform comparably to the predicate device and don't introduce new safety or effectiveness concerns. The "study" proving this is a series of non-clinical performance tests designed to validate and verify the device's adherence to relevant standards and its functional characteristics.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent due to the nature of a 510(k) submission for substantial equivalence:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way one might expect for a novel AI/ML device. Instead, it summarily states that the device "met all acceptance criteria" and "Performance testing data has demonstrated that the Accuryn Monitoring System is safe and effective for its intended use."

The closest a comparison table comes to "acceptance criteria" is the "Comments" column in the Comparison of Technological Characteristics and Device Use with Predicate Device section, where "Same" indicates meeting the implicit criterion of being equivalent to the predicate.

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The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days).

The Accuryn Monitoring System consists of the three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set, and the Accuryn Monitor.

The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable 16 French, twoway silicone urinary bladder catheter with two opposing drainage eyes and 4 lumens.

The first lumen of the Urinary Catheter is for urine drainage and is packaged pre-connected to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set function with the Accuryn Monitor to measure and display urine output and is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).

The second lumen is for the 5cc retention balloon, which serves to keep the catheter in place. Inflation of the retention balloon is provided by connecting a barrel tip syringe filled with sterile water to the catheter by means of a two-way valve. Sterile water is conveyed through the retention balloon lumen to inflate the retention balloon; water is contained within the balloon to maintain retention; the water is removed by reopening the valve to deflate the balloon prior to removing the catheter from the bladder.

The third lumen contains a thermistor wire for monitoring a patient's core body temperature in degrees Fahrenheit and degrees Celsius when connected to the Accuryn Monitor.

The fourth lumen consists of a closed air column that connects to a pressure transducer inside the Accuryn Monitor. Intra-abdominal pressure is measured via this lumen and displayed on the Monitor screen.

This 510(k) summary provides information on the Accuryn Monitoring System. However, it does not contain the details required to fully address all the requested points, especially concerning a traditional "study" in the sense of clinical trials or multi-reader, multi-case evaluations for AI. This is because the device appears to be a physical monitoring system, not an AI or imaging diagnostic tool.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what can be inferred and explicitly state where information is missing.

Acceptance Criteria and Device Performance (Inferred from general claims and predicate device equivalence)

The document states that "Results from the bench tests for design verification and validation have proven acceptable performance on all tests to indicate that the device is suitable for its intended use and is as safe and effective as the predicate devices to support a determination of substantial equivalence."

While specific numerical acceptance criteria and performance data are not provided in this summary, the FDA's clearance implies that the device met internal criteria based on the testing performed. The "reported device performance" is implicitly that it functions as intended for urine drainage/collection, urine output monitoring, core body temperature monitoring, and intra-abdominal pressure monitoring, with accuracy considered comparable to predicate devices.

Study Details:

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

   • Sample Size: Not specified. The performance evaluation primarily involved bench testing (e.g., biocompatibility, catheter performance, MR compatibility, electrical safety) rather than human clinical trials.
   • Data Provenance: Not specified, but given it's bench testing, the "data provenance" would relate to laboratory conditions and test setups, not patient data from specific countries. It is implicitly retrospective as the testing was completed prior to submission.

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

   • Not applicable in the context of this 510(k) summary. This device is a physical monitoring system and does not involve interpretation of images or data by human experts for ground truth establishment in the way AI/imaging devices might. Ground truth for its measurements would be established by reference standards in a lab setting.

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

   • Not applicable as this summary describes bench testing of a physical device, not a human reader study or AI algorithm evaluation requiring adjudication of expert opinions.

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 monitoring system, not an AI or imaging device that would typically undergo an MRMC study.

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

   • The "software-related documentation" was provided for a "Moderate Level of Concern device" (per FDA Guidance 2005). However, this refers to the embedded software in the monitor, not a standalone AI algorithm for diagnostic interpretation in the sense typically asked for in these questions. The performance evaluation was of the system (catheter + monitor) as a whole for its intended physiological measurements.

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

   • Bench Testing Standards: For the physical characteristics and measurement capabilities, ground truth was implicitly established against established scientific and engineering standards (e.g., ASTM, IEC, ISO) and reference methods/equipment used in the bench tests. For example, temperature measurements would be validated against calibrated thermometers, and pressure measurements against calibrated pressure transducers.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. Its design and validation rely on engineering principles, material science, and performance testing against established standards.

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

   • Not applicable for the same reason as above.

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The UFM is a urine flow measuring system.

The UFS provides real-time urine flow measurement, in men, by analyzing specific sound areas that are produced by the urine as it impacts the water surface.
The system consists of a laptop with proprietary software and a microphone to capture the sound. Real time urine flow is displayed on the monitor during the test and Maximum Flow; Average Flow; Volume; Time to Maximum and Void Time are calculated and displayed on the monitor upon completion of the test.

The provided document is a 510(k) summary for a Uroflow meter (UFM) by BE Technologies, Inc. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would allow a comprehensive answer to all the questions posed.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The UFM and predicate device have an equivalent accuracy related to flow and volume." and "Performance testing has demonstrated the UFM and the predicate device have equivalent technological characteristic for measuring urine flow. Both devices have the ability to capture flow rates at the maximum limits of male urination."

However, specific numerical acceptance criteria (e.g., within X% of the predicate or gold standard) and detailed reported performance metrics are not provided in this summary. The document only makes a general statement about equivalence.

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

This information is not provided in the document. The document mentions "Performance Data" but does not detail the study design, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document. For a uroflowmeter, ground truth is typically established by direct measurement (e.g., weighing urine over time), not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data where human experts disagree. A uroflow meter measures physiological parameters, and its performance is validated against a reference measurement, not expert consensus on interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided and is not applicable in the context of a uroflowmeter. MRMC studies are used for diagnostic imaging or similar devices where human readers interpret data. A uroflowmeter is an automated measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, based on the description, the UFM is a standalone device. Its performance data refers to the device's ability to measure urine flow independently. The statement "The UFS provides real-time urine flow measurement... by analyzing specific sound areas" and "The system consists of a laptop with proprietary software and a microphone to capture the sound" indicates a standalone algorithm.

7. The Type of Ground Truth Used

The document implicitly suggests that the ground truth for comparison was the predicate device's measurement based on weight. The text states: "The predicate device calculates flow based on weight; the UFM is based on sound, both methods are scientifically sound." This implies that the UFM's sound-based measurements were compared against the weight-based measurements of the predicate device as a reference.

8. The Sample Size for the Training Set

This information is not provided in the document. The document mentions "Performance Data" and "Software Verification and Validation Testing" but does not detail a training set for the algorithm.

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

This information is not provided in the document. If a training set was used for the sound-based algorithm, its ground truth would presumably be established via a reference measurement method (e.g., direct gravimetric measurement of urine flow) corresponding to the sound signatures.

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This device is intended to measure/ display collected urine volume. It detects fill level and temperature.

iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the iBag™ Urine Management System:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device's specifications for volume accuracy and temperature range are used as a proxy for acceptance criteria where the iBag™ device states "SAME" or explicitly meets/exceeds them. For other tests, the text indicates that the testing was "successfully conducted" or that the device meets the respective standard.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document does not specify the sample sizes for the "Fill level accuracy" or "Temperature measurement accuracy" tests, nor for the "User Feedback Study" or "Simulated Use Testing."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device" and lists the tests conducted.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the tests.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods for the test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size related to human readers improving with or without AI assistance. This device is not an AI-based system.

6. Standalone Performance (Algorithm Only)

The document primarily focuses on the device's mechanical and electronic performance, not on an algorithm's standalone performance. It states that "iBag™ provides accurate, real-time assistive data" and "Software is designed to be used with little or no training," but does not detail an algorithm's standalone performance separate from the hardware.

7. Type of Ground Truth Used

Based on the provided information, the ground truth for volume and temperature accuracy would likely be established through:

• Reference measurements: Using highly accurate, calibrated instruments to measure actual urine volume and temperature.
• Bench testing: Controlled laboratory conditions for precise measurements.

For other tests like electrical safety, EMC, leak testing, and sterility, the ground truth would be defined by the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2) and their specific test protocols.

8. Sample Size for the Training Set

No information is provided about a "training set" as this device is not an AI/ML-based system requiring a training phase in the typical sense. The testing described is for performance validation, not algorithm training.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.

All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.

The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.

The provided 510(k) summary for the Laborie Medical Technologies Urodynamic System with Tetra Accessory is for a Class II medical device that measures urodynamic parameters. It's important to note that this submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a new drug or a high-risk AI device might.

Therefore, the study information requested regarding acceptance criteria and performance metrics (e.g., sensitivity, specificity, reader improvement with AI) is not applicable in the context of this 510(k) summary. The summary focuses on bench testing and a clinical study to confirm the efficacy of the system and its accessory, as well as safety testing, but these are not described with specific acceptance criteria in terms of diagnostic performance.

Here's an breakdown of the available information:

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

This information is not provided in the 510(k) summary in the traditional sense of diagnostic performance metrics with defined acceptance criteria. The summary lists technical specifications for the UDS-94 and Tetra Accessory, which are inherent design parameters rather than performance outcomes against a gold standard in a diagnostic context.

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

The 510(k) summary states "Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory," but does not provide details on the sample size, data provenance, or study design (retrospective/prospective) for these studies.

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 in the 510(k) summary. Since the submission focuses on substantial equivalence for a device measuring physiological parameters, the method of "establishing ground truth" for diagnostic accuracy involving expert consensus would not typically be a primary focus for this type of device.

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

This information is not 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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. The Tetra Accessory uses near-infrared spectroscopy for non-invasive bladder activity detection; it is a measurement device, not an AI diagnostic tool designed to assist human readers in interpreting complex images or data in a way that would require an MRMC study.

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

A standalone algorithm performance study is not applicable as the device is not an AI algorithm. The Tetra accessory is a physical component that uses near-infrared spectroscopy to detect bladder activity. It's a measurement device intended for use by a healthcare professional, not a standalone diagnostic algorithm.

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

The 510(k) summary does not specify the "ground truth" used for the efficacy confirmation. For a urodynamic system, "efficacy" would likely relate to the accuracy and reliability of its physiological measurements compared to established standards or clinical observations, rather than a diagnostic 'ground truth' like pathology.

8. The sample size for the training set:

As this is not an AI/ML device, there is no training set in the conventional sense.

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

As mentioned above, there is no training set and therefore no ground truth establishment for a training set.

In summary:

The provided document describes a 510(k) submission for a medical device that measures physiological parameters. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, focusing on technical specifications and safety rather than a detailed performance study with diagnostic acceptance criteria. As such, many of the requested details regarding AI/ML device performance validation metrics are not applicable to this submission.

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The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

This document describes the Philips M2376A DeviceLink System, a device intended for electronic data collection and clinical information management from external medical devices. However, the provided text does not contain information typically associated with acceptance criteria and studies proving device performance in the context of diagnostic or therapeutic medical devices.

Instead, this is a 510(k) summary filed with the FDA, primarily focusing on proving substantial equivalence to previously marketed devices. The key elements of this filing are:

• Device Description: What the DeviceLink system is and what it does (receives digital data from external devices, converts it to HL7, and transmits it to a Clinical Information System).
• Intended Use: For electronic data collection and clinical information management. Critically, it explicitly states it is not for monitoring purposes and does not control attached source devices. This clarifies its role as a data intermediary, not a diagnostic or treatment device itself.
• Predicate Devices: The 510(k) process relies on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices. The document lists several types of externally connected devices (e.g., blood pressure computers, cardiac monitors, infusion pumps) that the DeviceLink system can interface with.

Given this context, the questions you've asked about acceptance criteria and performance studies (sample size, ground truth, expert opinions, MRMC studies, standalone performance, training sets) are generally applicable to devices that make a diagnostic claim, provide a therapy, or have a direct impact on patient outcomes based on their own internal performance. The DeviceLink System, as described, is a data integration tool. Its "performance" would likely be evaluated on:

• Data Integrity: Does it accurately transmit the data received from the external devices?
• Data Format Conversion: Does it correctly convert data to HL7?
• Interoperability: Does it successfully connect and communicate with specified external devices and Clinical Information Systems?
• Reliability/Availability: Does it operate consistently without significant downtime or data loss?

The 510(k) summary provided does not detail specific studies or acceptance criteria for these types of performance metrics. The FDA's letter primarily acknowledges the review of the submission and the determination of substantial equivalence, which is a regulatory classification, not an endorsement of detailed performance study results in the common sense of device efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not contain that information for this specific type of device (a data integration system).

If this were a diagnostic AI device, for example, the information would be structured very differently, with explicit sensitivity, specificity, accuracy, and ROC curve analyses. For a data integration device, the "acceptance criteria" and "study" would likely refer to internal validation tests for data accuracy, throughput, and interoperability, which are not typically detailed in a publicly available 510(k) summary in the way you've outlined.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a data integration device, not a performance study report for a diagnostic or therapeutic medical device.

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The M2376A DeviceLink System is indicated for use in data collection and clinical information management either correctly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

The provided text is a 510(k) summary for the Philips Medical Systems M2376A DeviceLink System. This document focuses on demonstrating substantial equivalence to a predicate device and obtaining market clearance, rather than conducting a detailed performance study with acceptance criteria in the manner typically associated with AI/ML-based medical devices or diagnostic tools.

Therefore, many of the requested elements for a performance study (like acceptance criteria, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable or not present in this type of regulatory submission. The DeviceLink System appears to be an electronic data collection and clinical information management system, not a diagnostic algorithm that produces results needing expert adjudication or performance metrics like sensitivity/specificity.

Here's why each point is largely not applicable or cannot be extracted from the provided text:

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

   • Not applicable / Not Present: The document describes the functionality of the device (receiving digital data, converting to HL7, transmitting to CIS) and its intended use (electronic data collection, clinical information management). It does not present quantitative performance metrics (e.g., accuracy, precision, latency) against specific acceptance criteria because it's not a diagnostic or treatment device with such outputs. The regulatory focus is on its ability to safely and effectively transfer data, and its substantial equivalence to existing devices.

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 / Not Present: There is no mention of a "test set" in the context of evaluating diagnostic performance. The device is a data integration system. Its "testing" would revolve around verifying proper data transmission and conversion, rather than analyzing a dataset for diagnostic accuracy.

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 / Not Present: "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Its function is data integration.

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

   • Not applicable / Not Present: Adjudication methods are used to resolve discrepancies in expert readings for diagnostic algorithms. This concept doesn't apply to a data integration system.

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 / Not Present: The DeviceLink System is not an AI-assisted diagnostic tool for human readers. It's a data transfer system.

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

   • Not applicable / Not Present: This is not an algorithm-only diagnostic device. Its "performance" would be related to its ability to correctly process and transmit data, which would be verified through system integration testing, but not typically described in terms of "standalone performance" like a diagnostic algorithm.

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

   • Not applicable / Not Present: As discussed, the concept of "ground truth" for diagnostic purposes is not applicable to this data integration device.

8. The sample size for the training set

   • Not applicable / Not Present: Since this is not an AI/ML device that learns from a training set, the concept of a "training set" is irrelevant.

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

   • Not applicable / Not Present: See point 8.

Summary based on the Provided Text:

The Philips Medical Systems M2376A DeviceLink System is a device intended for electronic data collection and clinical information management by receiving digital data from external devices, converting it to HL7 format, and transmitting it to a networked Clinical Information System. It is explicitly stated that the device is not for monitoring purposes, nor does it control any connected clinical devices.

The 510(k) submission focuses on establishing substantial equivalence to existing predicate devices, as per the FDA's regulatory pathway for such devices. The document lists the types of external medical devices it can connect to and their respective regulatory classifications and product codes. The "Indications for Use" statement defines its intended function: "data collection and clinical information management either correctly or through networks with independent bedside devices."

The regulatory review process, as evidenced by the FDA letter, confirms that the agency "reviewed your Section 510(k) premarket notification of intent to market... and have determined the device is substantially equivalent (for the indications referenced above) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This determination allows the device to proceed to market under general controls.

In conclusion, the document does not present a typical performance study with acceptance criteria because the device's nature (data integration) and the regulatory pathway chosen (510(k) for substantial equivalence) do not require such a study for market clearance. The "proof" the device meets acceptance criteria lies in its demonstration of substantial equivalence to already cleared devices performing similar data handling functions, and its adherence to general controls and good manufacturing practices.

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The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided document (K033680) is a 510(k) summary for the Philips M2376A DeviceLink System, submitted to the FDA in 2003. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, primarily by describing the device's function and intended use.

Critically, the provided text DOES NOT contain specific information about:

• Acceptance Criteria for Device Performance: The document describes the function of the device (receiving, converting, and transmitting data) and its intended use (data collection and clinical information management), but it doesn't define any quantitative or qualitative performance metrics (e.g., data accuracy, latency, error rates) that the device must meet.
• Studies Proving Device Meets Acceptance Criteria: Since no acceptance criteria are explicitly stated for device performance, there are no details of a study designed to prove the device meets such criteria. The 510(k) process primarily assesses substantial equivalence, which often involves comparing the new device's technological characteristics and intended use to a legally marketed predicate, rather than extensive performance studies against pre-defined acceptance criteria for a novel functionality.
• AI/ML Specifics: The device, as described, is a data integration system and does not appear to incorporate artificial intelligence or machine learning components. Therefore, questions related to AI-specific studies (e.g., MRMC, standalone AI performance) are not applicable.

However, based on the information available, we can extract the following:

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

Explanation: The document does not provide quantifiable "acceptance criteria" in the sense of performance thresholds (e.g., "data conversion must achieve 99% accuracy"). Instead, the "acceptance criteria" for K033680 are primarily related to:

• Functional capabilities: What the device does.
• Intended Use: How the device should be used and not used.
• Safety characteristics: Design elements that prevent potential hazards.

The "reported device performance" in the table above consists of descriptive statements from the document itself, outlining the device's capabilities and limitations as stated by the manufacturer for regulatory review. There are no results from specific performance tests against numerical targets.

Additional Information (as requested, but not explicitly present for this device's performance):

2. Sample size used for the test set and the data provenance: Not applicable as no performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. The device is a data integration system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a data integration system, not an algorithm with performance evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided K033680 document:

The K033680 document is a regulatory submission for a data integration device. Its primary purpose is to demonstrate substantial equivalence to a predicate device by describing its intended use, technological characteristics, and safety features. It doesn't include details of performance studies against specific, quantifiable acceptance criteria, as might be found for devices with diagnostic or therapeutic functions that require extensive clinical or technical performance validation. The "acceptance" in this context refers to FDA's determination of substantial equivalence, allowing the device to be marketed.

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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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The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

The provided text is a 510(k) summary for the Philips M2376A DeviceLink System. It primarily focuses on the device's function, classification, and substantial equivalence to predicate devices. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary describes the device as one that "receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System." Its intended use is "for electronic data collection and clinical information management." It explicitly states that "DeviceLink is neither patient connected, nor does it remotely control the attached source device."

Because the device's function is data conversion and transmission within a medical information system, and not diagnostics or treatment, the regulatory approval process for such a device typically focuses on aspects like:

• Software Validation: Ensuring the software correctly performs its data conversion and transmission functions.
• Interoperability: Verifying it can correctly interface with various medical devices and clinical information systems.
• Data Integrity and Security: Ensuring data is accurately and securely transferred, without loss or corruption.
• Risk Management: Assessing and mitigating any potential risks associated with data handling.

However, the provided document does not detail any specific performance acceptance criteria or a study that evaluates these criteria. Therefore, I cannot extract the requested information.

If this were a diagnostic or AI-driven device, the information you requested would be critical. However, for a data integration device like this, the nature of "performance" and its "study" would be different and is not described in this 510(k) summary.

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