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The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.

Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip, The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire

This is a 510(k) summary for a medical device and does not contain information about a clinical study with detailed acceptance criteria and performance metrics in the way you've requested for an AI/ML device.

Here's an explanation of why the requested information cannot be fully provided based on the provided text, and what can be extracted:

• Device: Suprapubic Catheter and Introducer Set
• Submission Type: 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as might be required for a PMA or for an AI/ML device.

Analysis of the Provided Text (and why it doesn't fit the AI/ML study request)

The document describes a conventional medical device (catheter and introducer set) and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on:

• Indications for Use: Identical or similar to predicates.
• Technology and Construction: Identical or substantially equivalent materials, design, manufacturing, shape, and sizes, with the catheter often being an OEM product from a predicate manufacturer.
• Environments of Use: Identical to predicates.
• Patient Population: Identical to predicates.
• Indwelling Time: Identical to predicates.
• Convenience Kit: Comparison of kit components.
• Non-Clinical Testing Summary: This is the only area where "testing" is mentioned, but it's for physical performance of the device components (balloon burst, volume maintenance, deflation, guidewire fracture, flexion, tensile strength, corrosion) against established standards (ASTM F623, ISO 11070). This is not a study assessing diagnostic accuracy or clinical outcomes in humans, nor does it involve AI/ML.
• Materials: Biocompatibility testing per ISO 10993-1 and G95-1.

Therefore, many of your specific requests are not applicable to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: The "performance" reported here is adherence to physical/material standards, not diagnostic accuracy. The acceptance criteria are "met the performance requirements of the standards" (ASTM F623, ISO 11070).
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an algorithm. The testing is material/device-specific.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a clinical sense.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted device.
6. Standalone (algorithm only) performance: Not applicable. There's no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

What can be extracted (re-interpreting "acceptance criteria" for a 510(k) of a conventional device):

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices and meeting relevant recognized standards for the device's physical and material properties.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Focus)

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The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. Environment of use - hospital and sub-acute settings. Patient population - Non-intubated patients who are breathing spontaneously.

The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide. The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line. In addition, it has air entrainment holes to supply room air if needed. It is available in sizes ranging from large to snuall, similar to the predicate device.

Here's a breakdown of the acceptance criteria and the study information for the Capnomask, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document defines substantial equivalence primarily by comparing the proposed device (Capnomask) to a predicate device (Capnoxygen LLC Capnoxygen mask K971229) across various attributes. The acceptance criteria are implicitly defined by the predicate's characteristics and performance, with the Capnomask demonstrating equivalence.

Here's a table summarizing the comparison, with performance essentially being "determined to be substantially equivalent" or "identical" to the predicate.

Study Details

The document describes non-clinical testing performed to establish substantial equivalence.

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

   • The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many devices were tested or how many breathing cycles/scenarios were performed. The testing described is "at various breathing rates, tidal volumes, and oxygen flow rates."
   • Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission seeking clearance in the US, these tests would typically be performed internally or by a contracted lab as pre-market validation studies. There's no mention of external clinical data or specific geographic origin for the test data itself (e.g., country of origin for the data). It is a retrospective evaluation of the device's technical and performance characteristics.

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

   • Not applicable in this context. The "ground truth" for the performance testing (CO2 sampling, pressure drop, etc.) would be established by validated test equipment and scientific measurements, not by expert human interpretation of medical images or observations. The comparison is against the predicate device's established performance, implicitly considered the benchmark.

3. Adjudication method for the test set:

   • Not applicable. This type of performance testing involves objective measurements rather than subjective human assessment requiring adjudication.

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

   • No. This is a medical device (oxygen mask with CO2 sampling), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI-assisted improvements for human readers are irrelevant to this submission.

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

   • Not applicable. This device does not involve an algorithm. It is a passive device (mask) with a port for sampling gas for an external monitor. Its performance is inherent in its design and ability to deliver oxygen and allow for accurate gas sampling, not in an independent algorithm.

6. The type of ground truth used:

   • For performance testing (CO2 sampling and waveform, pressure drop, resistance): The ground truth would be established by objective physical measurements using calibrated laboratory equipment and gas analyzers. The "truth" is what is measured by these instruments under controlled conditions. The comparison is then made against the predicate device's measured performance under similar conditions.
   • For material biocompatibility: Standardized ISO 10993 biological evaluation tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Total VOC) serve as the ground truth for safety.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

   • Not applicable, as there is no training set for this device.

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The Mediplus Single Use Anorectal GI Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract.

The Mediplus Single Use Anorectal GI Manometry catheter is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.

Mediplus Single Use Anorectal GI Manometry Catheters are designed for the monitoring of anorectal canal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Anorectal GJ Manometry Catheter is a multilumen PVC tube.

The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the anorectal gastrointestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.

The provided text describes a 510(k) premarket notification for the "Mediplus Single Use Anorectal Manometry Catheter." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.

While the document states that the device has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K951 for the intended use, it does not provide a table of acceptance criteria for specific performance metrics (e.g., pressure accuracy, flow rates, durability) or a study report detailing how those criteria were met.

Therefore, many of the requested details about performance studies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.

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 provided. The document states testing was done for biocompatibility and 510(k) memorandum requirements, but does not specify sample sizes or data provenance for these tests. This is a 510(k) submission, which primarily focuses on substantial equivalence rather than detailed clinical performance studies often submitted for PMAs.

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

• Not applicable/Not provided. The type of testing mentioned (biocompatibility, technological equivalence) does not typically involve expert review for ground truth in the same way clinical diagnostic device studies would.

4. Adjudication method for the test set:

• Not applicable/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:

• Not applicable. This device is an anorectal manometry catheter, not an AI-powered diagnostic imaging device. No MRMC study was done.

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

• Not applicable. This is a medical device, not a standalone AI algorithm. It is used by a "trained physician."

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

• For biocompatibility, the ground truth would be established by validated test methods and standards (e.g., ISO 10993).
• For technological characteristics, the ground truth is the specifications and materials of the predicate device.
• No other ground truth relevant to clinical performance is discussed.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

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The Mediplus Single Use GI Manometry Catheter is intended for water-perfused manometry of the GI tract. The Mediplus Single Use & Manometry Catheter is inducation for use when measurements of gastrointestinal tract pressures are needed for the diagnosis of suspected gastrointestinal disonders : - Investigation of gastrantestinal diseases - motility dison - Swallowing disorders - Refury disorders - Gastric and intestine disorders - Coloniec and anorectal disorders

Mediblus GI Motility Manometric Catheters are design for the monitoring of gastrointestinal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Manometric Catheter is a multi-lumen PVC tube. The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the upper gastro-intestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.

The provided text is a 510(k) Premarket Notification for a Mediplus Single Use GI Manometry Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity of a diagnostic algorithm.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth for a diagnostic AI device is not applicable to this submission. This is a medical device, specifically a catheter, not an AI or diagnostic algorithm, and its approval relies on demonstrating that it is as safe and effective as legally marketed predicate devices, not on specific performance metrics established through clinical studies in the same way an AI diagnostic would be.

Here's an analysis based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. This means that the device must be as safe and effective as a predicate device, and it must have the same intended use and technological characteristics, or if there are differences, those differences must not raise new questions of safety or effectiveness.
  • The document explicitly states: "The Mediplus GI Monitoring Catheter is technologically equivalent to both predicate devices in design and physical characteristics. Like the Arndorfer catheter, it is made of PVC, which has been used historically for intubations."
  • It also states: "The Mediplus GI Manometry Catheter has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K95-1for the intended use of the device."
• Reported Device Performance: The document does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or precision of pressure measurements) in the way a diagnostic algorithm would. Instead, its "performance" is demonstrated by its inherent properties and by showing it meets safety standards equivalent to predicate devices.
  • Biocompatibility: Meets ISO 10993 and USFDA 510(k) Memorandum - # K95-1.
  • Material: Made of PVC, "which has been used historically for intubations" (implying established safety and effectiveness).
  • Function: Designed for "monitoring of gastrointestinal pressure" by transmitting pressure via water perfusion to a transducer. The functional performance is implicitly considered equivalent to the predicate devices.

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

• Not applicable. This submission does not involve a "test set" of diagnostic data for performance evaluation in the context of an algorithm. The evaluation is based on device design, materials, and safety testing on the device itself, not on patient data for diagnostic accuracy.

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

• Not applicable. As there is no test set of diagnostic data, there are no experts establishing ground truth in this context. The "ground truth" here relates to the safety and functional equivalence of the device, which is evaluated by the FDA based on the manufacturer's submission and predicate device comparison.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or expert adjudication process is detailed in this type of 510(k) submission for a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable. This is a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation. Such a study would be relevant for an AI-powered diagnostic tool, not for this device.

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

• Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For this device, the "ground truth" for evaluation primarily centers on device safety standards, material properties, and functional principles proven safe and effective by predicate devices.
  • Biocompatibility: Demonstrated by testing against ISO 10993 and USFDA 510(k) Memorandum - # K95-1.
  • Material Equivalence: PVC is a historically used material, forming a basis of known safety.
  • Functional Equivalence: The design for water-perfused manometry, transmitting pressure to a transducer, is considered functionally equivalent to the predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/algorithm, there is no "training set."

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

• Not applicable. No training set exists for this type of device submission.

In summary: The provided document is a 510(k) premarket notification for a Class II medical device (GI Manometry Catheter). Its approval is based on demonstrating substantial equivalence to existing predicate devices regarding intended use, technological characteristics, and safety considerations (like biocompatibility and material choice), rather than clinical performance metrics typically associated with diagnostic algorithms or AI-driven systems. Therefore, most of the questions relating to performance studies of an AI model are not relevant to this specific document.

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