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The Glean Urodynamics System is a urodynamics analyzer system that is intended to quantify the pressure and flow characteristics of the lower-urinary tract. The system can be used in adult patients only to perform standard urodynamic tests such as Uroflow, Cystometrogram (CMG), Urethral Pressure Profile (UPP) and Micturition Studies.

The major application of urodynamics is the diagnosis of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The system is intended to be used as medical diagnostic equipment.

The Glean Urodynamics System (GUS) is a single-channel urodynamic system indicated for standard Urodynamic tests such as Uroflow (UF), Cystometrogram (CMG), Urethral Pressure Profile (UPP), and Micturition Studies (MS).

GUS consists of the following three physical component elements: Sensor, Insertion Tool, and Uroflowmeter, as well as the following three software applications: Glean Mobile App (Clinician), Glean Mobile App (Patient), and Glean Web App. The patient may use the Glean Mobile App as a digital voiding diary, logging fluid input, leakage, urgency, and other urological symptoms. The clinician may use the Glean Mobile App to prepare the Sensor for insertion, log symptoms, and download data. The Glean Web App may be used by clinicians to view and analyze data.

The Sensor can be inserted through the urethra into the bladder using the Insertion Tool. Once inserted, the Sensor has a Removal String that hanss out of the urethra to enable removal of the Sensor may stay in the bladder for the entire duration of monitoring while collecting data. The Sensor stores data that may be wirelessly transmitted to the Glean Mobile App (Clinician) once it is removed from the body.

The Uroflowmeter is used to measure voided volume and flow. The Glean Mobile App (Clinician) wirelessly receives data from the Uroflowmeter after the patient has completed a voiding cycle.

The provided text describes a 510(k) submission for the "Glean Urodynamics System," but it does not contain information related to an AI/ML-driven device or its acceptance criteria and study proving its performance. The document is a traditional medical device 510(k) clearance letter and summary, focusing on non-clinical and clinical testing for a hardware-based urodynamics measurement system.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance, ground truth, expert adjudication, or MRMC studies. The document discusses:

• Non-clinical testing: Biocompatibility, Electrical Safety, EMC, Software Verification and Validation, Sterilization validation, Cybersecurity, Human Factors Engineering, and an animal safety study. All pre-determined acceptance criteria for these tests were met.
• Clinical testing (for device feasibility, efficacy, and safety): A prospective, open-label, multi-center, interventional study involving 38 participants. The study focused on the device's ability to record vesical pressure, ease of insertion/removal, patient comfort, and clinician interpretation of results compared to conventional urodynamics.

The "acceptance criteria" mentioned in the document refer to the successful completion of these non-clinical and clinical tests, affirming general device performance and safety, not AI/ML-specific metrics like accuracy, sensitivity, or specificity against established ground truth as would be evaluated for an AI algorithm.

If you intended to provide a different document for an AI/ML device, please provide that text.

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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 Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.

The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink.

Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.

The provided 510(k) summary for the Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode (K113771) describes a non-clinical study to support substantial equivalence. It does not present acceptance criteria or detailed performance data for clinical use, nor does it describe a study involving human subjects or AI.

Here's an analysis based on your request, highlighting what information is not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than defining specific performance metrics or acceptance criteria related to its intended physiological function (mucosal surface stimulation/recording) in a clinical setting.

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

• Sample Size for Test Set: Not applicable, as this was a non-clinical study.
• Data Provenance: Not applicable, as this was a non-clinical study.

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

Not applicable, as this was a non-clinical study. The "ground truth" in this context would be engineering specifications and standards for electrical, biocompatibility, and sterilization testing.

4. Adjudication Method for the Test Set

Not applicable, as this was a non-clinical study.

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

No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with AI assistance. The Signal Gear Urethral Catheter Electrode is a medical instrument for stimulation/recording, not a diagnostic imaging device.

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

No, a standalone (algorithm only) study was not done and is not mentioned. The device is an electrode for use in conjunction with urodynamic evaluation, implying human operation and interpretation of data. There is no mention of an "algorithm" as a component of this device's performance.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and quality standards for manufacturing.
• Established international and industry standards for biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).
• Standards for accelerated aging (ASTM F1980-07).
• Standards for packaging validation (UNI EN ISO 868-5, 11607-1, DIN 58953-6).
• Standards for bioburden and sterility (UNI EN ISO 11737-1, 11737-2).

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, the ground truth for it was not established.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical):

The Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode underwent several non-clinical tests to demonstrate its safety and performance, and thus its substantial equivalence to the predicate device (Dantec 13L40 St Mark's Pudendal Electrode).

The study involved:

• Inspection for defects: Manufacturing, workmanship, and packaging.
• Electrical continuity testing: To ensure proper electrical function.
• Lead wire pull testing: To assess the mechanical strength of the lead wire attachment.
• Biocompatibility testing:
  • In vitro cytotoxicity: According to ISO 10993-5:2009.
  • Irritation and delayed-type hypersensitivity: According to ISO 10993-10:2010.
• Accelerated aging: Conducted according to ASTM F1980-07 to predict shelf life.
• Packaging validation tests: Conducted according to UNI EN ISO 868-5, 11607-1, and DIN 58953-6 to ensure package integrity and maintain sterility.
• Bioburden and sterility tests: Conducted according to UNI EN ISO 11737-1 and 11737-2 to confirm the device is sterile when packaged.

The document indicates that these non-clinical tests were sufficient to demonstrate that "No new questions of safety or effectiveness are raised," supporting its substantial equivalence to the predicate device. However, specific acceptance criteria for each test (e.g., minimum pull strength, maximum cytotoxicity score) and the quantitative results are not provided in this summary. The FDA's 510(k) clearance implies that the agency found these non-clinical tests adequate for demonstrating substantial equivalence based on the provided data.

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The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies. electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability.

The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including:

Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG

Cerebral Pudendal Somatosensory Evoked Potential

Sacral Reflexes

Calculations will include: latency, peak, duration, conduction velocity and area.

The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include:

• Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation .
• . Ring/Bar Stimulation Electrodes
• Needle/Cup/Patch EMG/ECG Electrodes .
• St. Mark's Electrode and Cable .
• EMG/ECG Cabling .

The provided 510(k) summary for the KOR2614 Laborie EVOX Electro Diagnostic Device does not contain the detailed study results, acceptance criteria, or performance data typically found in a comprehensive clinical or performance study report.

Instead, this document focuses on establishing substantial equivalence to predicate devices through technical characteristics and intended use. The "Testing" section explicitly states that "Bench studies have confirmed the efficacy of the EVOX Electro Diagnostic Device. Safety testing included electrical safety testing and electromagnetic compatibility testing to recognized standards." This indicates that the device's efficacy was confirmed via bench testing, not through a clinical study with human subjects, ground truth, or expert review in the way a diagnostic AI/ML device would be evaluated.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The document states "Bench studies have confirmed the efficacy," implying a technical verification rather than a clinical test set from patient data.

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

Not applicable. No clinical test set or human ground truth described.

4. Adjudication method for the test set

Not applicable. No clinical test set or human ground truth 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

No MRMC study was done. This device is an electro-diagnostic tool and not an AI-assisted diagnostic software in the context of this 510(k) summary.

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

This is a standalone electro-diagnostic device. Its performance is inherent in its technical capabilities for signal acquisition and processing. The "bench studies" mentioned would represent this standalone performance, although specific metrics are not detailed in this summary.

7. The type of ground truth used

For efficacy, the ground truth would have been established by comparing the device's output signals and measurements (e.g., latency, peak, duration, conduction velocity, area) against known, accurate electrical stimuli and reference measurements in a laboratory setting (bench testing).

For safety, the ground truth is established by the specified electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-10).

8. The sample size for the training set

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

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

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

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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 Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).

The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.

The provided text is a 510(k) summary for the Bard® Intra-abdominal Pressure Monitoring Device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states: "The results of bench and biocompatibility testing demonstrated that the functionality, integrity, and safety of the Bard IAP Device is adequate for its intended use and support a determination of substantial equivalence." However, it does not provide specific acceptance criteria values, reported performance metrics, or details about the studies themselves (e.g., sample size, data provenance, ground truth, expert qualifications, adjudication methods, or specific comparative effectiveness results).

Therefore, I can only partially fulfill your request based on the information provided.

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

1. Table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria and reported device performance values are not explicitly stated. The general statement is given under "Summary of performance data":

Note: This table reflects the general claims made in the summary. It does not provide quantitative metrics or specific pass/fail thresholds that would typically be found in detailed study reports.

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

Not specified in the provided text. The document only mentions "bench and biocompatibility testing" without detailing the sample sizes (e.g., number of devices tested, number of measurements taken) or the provenance of any data (e.g., country of origin, retrospective/prospective nature).

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

Not applicable/Not specified. The provided summary mentions "bench and biocompatibility testing." This type of testing typically involves engineering or laboratory measurements against established standards, not necessarily human expert-established ground truth in the way it might apply to diagnostic imaging or clinical assessment devices. No experts are mentioned in this context.

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

Not applicable/Not specified. As the testing described is "bench and biocompatibility," an adjudication method for a test set (presumably clinical or image-based) is not relevant or mentioned.

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

No, an MRMC comparative effectiveness study was not done. This device is a measurement tool (an intra-abdominal pressure monitoring device), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance in that context. The summary describes "bench and biocompatibility testing" for the device's physical and functional attributes.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device for measuring pressure. The performance evaluated would be the direct measurement capabilities of the device itself.

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

For "bench testing," the ground truth would typically be established by controlled experimental conditions or calibrated reference standards. For example, pressure measurements would be compared against a known, precise pressure source. For "biocompatibility testing," the ground truth would be established by standardized laboratory assays and adherence to relevant ISO standards (e.g., ISO 10993 series) to assess material safety. The document does not provide details on these specific ground truths.

8. The sample size for the training set

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

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

Not applicable. This device is not an AI/ML device that requires a training set and established ground truth in that context.

In summary, the provided 510(k) pertains to a physical medical device for pressure monitoring and focuses on establishing substantial equivalence through bench and biocompatibility testing. It lacks the detailed quantitative performance metrics, study designs, and human-expert-related information that would be typical for AI/ML-based diagnostic devices.

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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 pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures.

Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H20 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.

Single Channel Urological Pressure Gauge

This is a 510(k) clearance letter from the FDA for a Single Channel Urological Pressure Gauge and its Indications For Use. This document does not contain information typically found in a study describing acceptance criteria and device performance.

Therefore, I cannot provide the requested information. This document is a regulatory approval notice, not a study report.

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