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The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.

The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies.

The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.

The provided text describes the acceptance criteria and study proving the CT3000Pro's performance, but it primarily focuses on substantial equivalence for regulatory clearance rather than a detailed AI model performance study. The text does not describe an AI/ML-driven device.

From the provided text, the CT3000Pro is a urodynamics measurement system. The performance data section describes standard device verification and validation activities, software validation, and clinical data from literature regarding the UroCuff for non-invasive urodynamic studies. There is no mention of an AI/ML algorithm or related performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the acceptance criteria and study of an AI/ML device is not possible based on the provided document.

However, I can extract information related to the device's functional performance and the clinical evidence presented for its substantial equivalence, interpreting "acceptance criteria" as meeting regulatory standards for a non-AI medical device.

Based on the provided document, here's an interpretation of the requested information, acknowledging the absence of AI/ML specifics:

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

Since this is a non-AI device application, the "acceptance criteria" are not related to typical AI performance metrics (like sensitivity, specificity, or AUC). Instead, they are related to the device's functional and safety characteristics, and its equivalence to a predicate device. The document implies compliance with relevant standards and successful completion of verification and validation.

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

• Test Set (Clinical Data for Non-invasive Uroflow): The clinical performance for the non-invasive uroflow measurement technique (UroCuff) was demonstrated through published literature. A specific study mentioned involved over 50,000 UroCuff patients.
• Data Provenance: The explicit provenance of this large patient dataset is "103 US hospitals and urology offices." The study is described as having been published in the Journal of Urology by authors practicing at Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology. The data collection would be retrospective as it's based on clinical experiences that have already occurred and been published.

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

The document describes a urodynamics measurement system, not an AI model requiring ground truth established by experts for image or signal interpretation. The "ground truth" for this device's performance is the accurate measurement of physiological parameters (e.g., urine flow, pressure, EMG signals) during urodynamic testing and the clinical outcomes for UroCuff use. The validity of these measurements and clinical outcomes is established through standard medical practice and the rigor of published clinical studies. Experts (physicians) use the device and interpret its output in the clinical setting; their qualification would be "licensed physician or health care professional." For the clinical studies referenced, the "experts" are the authors and clinicians from institutions like Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology, who "utilize UroCuff." No specific number of "experts" for establishing ground truth in the context of an AI test set is relevant here.

4. Adjudication method for the test set:

Not applicable, as this is not an AI/ML performance study requiring adjudication of expert interpretations. The clinical data cited from literature represents clinical experience and measured outcomes.

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

Not applicable. This is not an AI/ML device that assists human readers.

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

Not applicable. The CT3000Pro is a medical device, not a standalone AI algorithm. Its function is to perform physiological measurements for diagnosis, always with a human healthcare professional in the loop.

7. The type of ground truth used:

For the device's functional performance, the "ground truth" is adherence to engineering specifications, accuracy of measurements, and compliance with electrical safety and EMC standards. For the UroCuff clinical performance, the "ground truth" is outcomes data and clinical experience from a large patient cohort, as reported in peer-reviewed literature, demonstrating the effectiveness and safety of the non-invasive measurement technique in assessing bladder activity.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set.

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The URONIRS 2000 device is intended to be used in conjunction with commercially available uroflowmeters and bladder ultrasound systems for noninvasive testing of bladder activity, aiding in the diagnosis of urinary incontinence and lower urinary tract symptoms. The device is used under the direction of a licensed physician or health care professional.

The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.

The URONIRS 2000 is an active medical device indicated for non-invasive testing of bladder activity in an office or hospital setting.

The device consists of a medical grade Tablet PC running the URONIRS application software, a URONIRS base station for data acquisition, a custom designed cable with an optical sensor end and a single use, disposable patch.

The base station provides the laser output and accepts NIRS data input from the sensor via the sensor cable and charges the Tablet PC when plugged in. The base station communicates with the tablet PC via Bluetooth.

During bladder voiding, URONIRS 2000 measures concentration changes in oxygenated haemoglobin (HbO2), de-oxygenated haemoglobin (Hb) and cytochrome (Cyt) while a commercial uroflowmeter simultaneously measures uroflow data (flow and volume). The data is sent to the tablet PC via Bluetooth connection for display to the clinical users.

The URONIRS 2000 device focuses on non-invasive bladder activity testing by measuring changes in oxygenated hemoglobin, de-oxygenated hemoglobin, and cytochrome during voiding while simultaneously record uroflow data (flow and volume). The provided document states that performance validation using actual clinical data showed that the URONIRS 2000 has the same performance as the predicate device (Urodynamic System Tetra Accessory cleared under K073552). However, it does not provide a table of specific acceptance criteria or reported device performance metrics against those criteria.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them, based on the input:

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

Unfortunately, the provided text does not include a table of specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly states: "Performance Validation using actual clinical data showed that the URONIRS 2000 has the same performance as the predicate device." This is a statement of equivalence rather than a detailed breakdown of performance against predefined targets.

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

The document mentions "Performance Validation using actual clinical data" but does not specify the sample size used for this test set, its country of origin, or whether the data was retrospective or prospective.

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)

The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications.

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

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

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a measurement system and not described as providing AI assistance to human readers in its stated intended use.

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

The document describes the URONIRS 2000 as a system that "measures concentration changes... while a commercial uroflowmeter simultaneously measures uroflow data... The data is sent to the tablet PC via Bluetooth connection for display to the clinical users." This implies that the device provides data to clinicians for interpretation, rather than issuing a diagnosis autonomously. Therefore, the concept of a "standalone (algorithm only)" performance study, as typically understood for diagnostic AI, does not directly apply here in the context of replacing human interpretation. Its performance is validated against a predicate device, which is also a measurement system for bladder activity.

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

The document broadly states "Performance Validation using actual clinical data." While this implies a comparison to a known clinical state, the specific type of ground truth used (e.g., expert consensus on urodynamic parameters, pathology findings, or long-term clinical outcomes) is not detailed. Given that it's comparing performance to a predicate urodynamic system, the ground truth would likely involve established urodynamic measurements or clinical diagnoses made using conventional methods.

8. The sample size for the training set

The document does not provide any information about a specific training set or its sample size. This suggests that the validation was focused on confirming equivalence to the predicate device, rather than training a novel AI algorithm from scratch.

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

As no training set is described, no information is provided on how its ground truth might have been established.

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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 Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.

The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:

• Neuro Free Run EMG
• Neuro Motor Nerve Conduction
• Neuro Sacral Reflex
  The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.
  The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.

This 510(k) summary describes a software update (Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1) and does not contain detailed acceptance criteria, performance data from a specific study, information on sample sizes, expert involvement for ground truth, or adjudication methods typically found in studies for new medical devices establishing clinical efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.

However, based on the provided text, here's a breakdown of what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neuro Urodynamic Suite. Instead, it relies on demonstrating equivalence to a predicate device. The primary performance claim is that the "enhanced system performs as its predicate system."

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified. The verification results are mentioned as "in-house" testing (Section 8), implying internal testing rather than external or patient-specific clinical data.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a new performance study. The evaluation relies on verification of the software's functionality and comparison to a predicate device.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. No adjudication method is mentioned as there's no described study involving multiple interpretations for a test set.

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

• No. The document explicitly states: "Clinical evaluation not performed." (Section 8). Therefore, no MRMC study, human-in-the-loop performance, or effect sizes of AI assistance are reported.

6. Standalone Performance Study (Algorithm Only):

• A standalone performance study was conducted, but it's referred to as "Verifications results" and "in-house" testing (Section 7 and 8). The exact methodology, metrics, and quantitative results of this "verification" are not provided in detail. The claim is that it performs as the predicate system. It's an algorithm-only evaluation as it's a software update.

7. Type of Ground Truth Used:

• The ground truth for the "verification results" is not explicitly defined in terms of clinical outcomes or pathology. Given that it's a software update for electrophysiological testing, the "ground truth" for the verification likely refers to whether the software accurately processes and displays expected electrophysiological signals and calculates parameters correctly, compared to a known good reference or the predicate device's behavior. It's a functional and performance comparison against the predicate, not a clinical diagnostic accuracy assessment.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This device is a software program for signal processing and parameter calculation in electrophysiology, not an AI/ML model that typically requires a training set of data.

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

• Not applicable/Not specified. No training set is described for this device.

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The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.

The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.

The provided text states that the In-Probe II Urodynamics System is "substantially equivalent" to two predicate devices: Influence, Inc.'s In-Probe Urodynamics System and Andronic Devices, Ltd.'s Insight electronic alignment indicator. The document also mentions "Performance testing and information in the application demonstrated that the In-Probe II system is biocompatible and provides equivalent performance to the original In-Probe Urodynamics System."

However, the provided text does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It mainly focuses on the FDA 510(k) clearance process based on substantial equivalence to predicate devices. Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided document.

To properly answer your request, more detailed performance study reports or technical specifications for the In-Probe II Urodynamics System would be required.

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The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.

The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.

The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.

The provided document is a 510(k) premarket notification for the Circon Endotek OM-4 Cystometry Pump. This type of submission is for establishing substantial equivalence to existing devices, not for demonstrating novel performance or conducting advanced clinical studies. Therefore, many of the requested elements for AI/ML device studies (like MRMC studies, specific performance metrics against an established ground truth, or details on sample sizes for training/test sets for AI models) are not applicable to this 1997 medical device submission.

This document describes a device used for measuring during cystometry, not an AI-powered diagnostic tool. The "performance criteria" described are typically related to the functional specifications and safety of the pump itself, rather than diagnostic accuracy metrics.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific numerical performance targets for diagnostic accuracy or device output error rates that would be typical for an AI/ML device.

Instead, the submission focuses on meeting voluntary standards and demonstrating substantial equivalence to predicate devices. The implicit "acceptance criteria" for a 510(k) of this nature are that the device is safe and effective for its intended use and performs comparably to legally marketed predicate devices.

The document states:

• "The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:" (However, the list of those standards is not provided in the excerpt.)

For this type of device, performance would typically relate to its ability to accurately pressurize the filling media, its flow rate, pressure consistency, safety features, and reliability. Specific numerical performance data for these aspects are not included in the provided excerpt.

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

Not Applicable (N/A) / Not Provided. This document describes a new hardware device (a pump) for cystometry, not an AI/ML diagnostic tool that would typically involve a "test set" of patient data in the modern sense. The submission would have involved engineering tests and perhaps a limited clinical evaluation for safety and basic functionality, but not "test sets" for diagnostic performance in the way AI/ML devices do.

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

Not Applicable (N/A). As this is not an AI/ML diagnostic device, there would be no "ground truth for a test set" related to diagnostic outcomes or classifications.

4. Adjudication method for the test set

Not Applicable (N/A). See explanation for question 3.

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. This device is a pump, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is applicable.

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

Not Applicable (N/A). This is a hardware pump, not an algorithm.

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

Not Applicable (N/A). No "ground truth" as typically understood for AI/ML diagnostic performance was established for this pump. The device's performance would be evaluated against its technical specifications (e.g., pressure accuracy, flow rate stability) and safety standards.

8. The sample size for the training set

Not Applicable (N/A). This is a hardware device submission, not an AI/ML algorithm requiring a "training set."

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

Not Applicable (N/A). See explanation for question 8.

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The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure catheter.
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liguid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test.

The LuMax Cystometry Tube Set consists of a vented spike with a drip chamber for connection to the liquid reservoir, usually a one to three liter saline or DI water bag, a roller clamp for regulating fluid flow rates, and a male luer lock connector for connecting to the filling lumen of the bladder catheter. It is assembled with polyurethane tubing giving it an overall length of 72 inches.

The LuMax Cystometry Tube Set is a Class II medical device intended to provide a conduit from a liquid reservoir to the infusion lumen of a bladder pressure catheter. The device was found to be substantially equivalent to an existing administration tube set from North American Sterilization and Packaging Company (NASP) (K911865/B).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Bench Testing: "Sample devices" were subjected to physical bench testing. The exact number of samples is not explicitly stated in the provided text, but it is implied that a sufficient number was tested to make a general statement about all samples meeting specifications.
• Sterilization Validation: "Sample product" was used for sterilization validation. The exact number of samples is not explicitly stated.
• Data Provenance: The data is retrospective, generated from in-house bench testing and sterilization validation performed by MedAmicus, Inc. The country of origin for the data is implicitly the United States, given the company's address and communication with the FDA.

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

No external experts were explicitly mentioned as being used to establish a ground truth for the device's performance in the provided text. The "ground truth" for the physical and sterilization tests was based on established engineering specifications and validation methods (e.g., AAMI method for sterilization).

4. Adjudication Method for the Test Set

Not applicable. The tests performed were objective physical and sterilization validation tests against predefined specifications, not subjective assessments requiring adjudication by multiple readers or experts.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or reported. This device is a passive conduit tube set, and its performance is not evaluated in terms of human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone study was performed. The device performance (physical bench testing, sterilization, and packaging) was evaluated in an "algorithm-only" or "device-only" manner without human interaction influencing the core performance metrics being tested. The device itself was the subject of the performance tests.

7. Type of Ground Truth Used

• Physical Bench Testing: Engineering specifications and material science standards (e.g., for tensile strength, pressure withstand) were used as the ground truth.
• Sterilization: The AAMI method's criteria for a Sterility Assurance Level (SAL) of better than 10⁻⁶, demonstrated by a complete kill of 1 million spores of Bacillus var niger after a half-cycle, served as the ground truth.

8. Sample Size for the Training Set

Not applicable. This device is a passive medical device, not an AI/ML algorithm requiring a "training set."

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

Not applicable. This device is a passive medical device, not an AI/ML algorithm requiring a "training set."

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The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders.
The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.

The Ellipse 4™ is a small, compact device that can register pressures, uroflow and EMG from the patient. The signals are AD converted and displayed on a LCD screen, printed on a thermal printer and stored in memory. After the recording, the data can be copied on a printer or downloaded to a PC using a network.
The Ellipse 4™ uses microp catheters (MTC's) for recording the pressures, and surface electrodes.

The provided text does not contain detailed acceptance criteria or a specific study that proves the device (Ellipse 4™) meets said criteria in the format requested. The document describes the device, its intended use, and briefly mentions "bench testing" and "clinical experience." However, it lacks the specificity required for the detailed table and information points.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text.
The document states:

• "Bench testing was performed to confirm accuracy of the basic parameters measured by the Ellipse 4™."
• "Tests were performed in the following areas: transducer, pump, EMG, pressure, pressure flow and urethral pressure profile."
• "Satisfactory results were achieved."

However, it does not specify what "satisfactory results" entail (i.e., the acceptance criteria) or the quantitative performance metrics achieved for each parameter.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a controlled study.
• Data Provenance: The document mentions "Clinical experience in use of the Ellipse 4™ has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the Ellipse 4™". This suggests retrospective collection of real-world usage data. The country of origin is not specified for these investigations, but the manufacturer is based in Germany.

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

This information is not available in the provided text. The document refers to "clinical experience" and "excellent results and an absence of complications," implying evaluation by medical professionals, but does not detail the process of establishing ground truth or the qualifications of evaluators.

4. Adjudication method for the test set

This information is not available in the provided text.

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

The Ellipse 4™ is described as an "Urodynamic System" that registers pressures, uroflow, and EMG. This is a diagnostic measurement device, not an AI-assisted interpretation system. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and not mentioned.

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

The device is a measurement system; its performance is inherent to its sensors and processing. The concept of an "algorithm only" performance study in the context of AI is not applicable as it's not an AI diagnostic tool. The "bench testing" mentioned might be considered a standalone performance evaluation of the hardware and integrated software for measurement accuracy.

7. The type of ground truth used

For the "clinical experience," the implied ground truth would be the clinical outcomes and the absence of complications as determined by medical professionals in a real-world setting. For the "bench testing," the ground truth would be known physical parameters against which the device's measurements were compared for accuracy.

8. The sample size for the training set

This information is not available in the provided text. As the device is a measurement system and not an AI model requiring a training phase, the concept of a "training set" in the context of machine learning is not directly applicable.

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

This information is not available and not applicable for the reasons mentioned in point 8.

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The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information.

General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.

The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.

The provided text describes a medical device, the Dantec Duet™, a computerized urodynamics measurement system, and its non-clinical testing and conclusion for a 510(k) submission. However, it does not contain the specific information required to complete a table of acceptance criteria, reported device performance, or details about a study to prove the device meets said criteria.

The document primarily focuses on:

• Device Description: What the Dantec Duet™ is and its components.
• Intended Use: For urodynamics testing to assist practitioners.
• Technological Characteristics: How it operates (records electrical signals, data acquisition, signal processing, accessory controls).
• Predicate Devices: Other similar devices on the market.
• Non-Clinical Testing: Mentions development and validation according to written procedures, comparison to predicate devices, in-house validation, and EMC/ESD testing by qualified laboratories.
• Conclusion: States it meets requirements, performs as well or better than marketed products, and is safe and effective.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document states "System testing and validation demonstrate that the device meets the requirements of internationally recognized standards, meets its published specifications, performs as well or better than the currently marketed product," but it does not list these specific standards, specifications, or the results of the performance against them.

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

• Cannot be provided. The document only mentions "in house validation" and "EMC and ESD testing." There is no information about test set sample sizes 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)

• Not applicable/Cannot be provided. This device is a measurement system, not one that generates interpretations requiring expert ground truth in the same way an AI diagnostic tool would. Its performance is likely evaluated against known physical standards or by comparison to predicate devices' measurements, not by expert consensus on generated data.

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

• Not applicable/Cannot be provided. Similar to point 3, this concept typically applies to subjective interpretations or classifications, not to the performance of a physical measurement 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. The Dantec Duet™ is a measurement system, not an AI diagnostic assistant. Its function is to collect and present data for human interpretation, not to augment human reading with AI.

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

• Not applicable. The device is described as a "computerized urodynamics measurement system" that "assists practitioners." Its primary function is data acquisition and presentation, not standalone diagnostic interpretation.

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

• Cannot be precisely determined from the text. For a measurement device, "ground truth" would typically involve calibrated standards, known physical values, or comparison against established, accurate measurement devices (e.g., predicate devices). The text mentions "in house validation" and comparison to "published specifications" and "currently marketed product," implying such methods, but doesn't detail them as "ground truth."

8. The sample size for the training set

• Not applicable/Cannot be provided. This device is from 1996 and is described as a "computerized urodynamics measurement system" with "Windows™ based application software." While it performs "signal processing," the description does not suggest the use of machine learning algorithms that require a "training set" in the modern sense. Its development involved "written validation procedures," which is standard software engineering, not AI model training.

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

• Not applicable/Cannot be provided. (See point 8).

Summary of what can be extracted (with caveats):

Study Description:
The document implies a non-clinical study was conducted as part of the validation process. This study involved:

• In-house validation: Likely testing of the system's components and overall function against design specifications.
• EMC (Electromagnetic Compatibility) and ESD (Electrostatic Discharge) testing: Performed by "qualified testing laboratories" to ensure the device operates correctly in its intended electromagnetic environment and is resistant to static electrical discharges.
• Comparison to predicate devices: To establish substantial equivalence in terms of intended use, labeling, and specifications.

Ground Truth (in context of a measurement device):
While not explicitly called "ground truth," the device's accuracy and performance were likely established by:

• Meeting published specifications: Implies comparison to precise physical standards or known values.
• Performing as well or better than the currently marketed product (predicate devices): This suggests comparative testing against existing, accepted devices.

Missing Information:
Crucially, the document lacks quantitative data, specific acceptance criteria values, performance metrics (e.g., accuracy, precision for different measurements), and detailed methodology of any performance study. This is typical for older 510(k) summaries which focused more on substantial equivalence and safety rather than detailed performance data as seen in modern AI/ML device submissions.

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