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When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.

When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.

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

Based on the provided text, the device in question is a Mark II / Mark III Manometric Perfusion Pump.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific quantifiable acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) for the device's performance. Instead, it focuses on the device's equivalence to a predicate device and its compliance with general safety and electrical standards.

The primary "performance" claim is that:

• "The device is equivalent in safety and performance to prior legally marketed devices."
• "Dentsleeve Pty Ltd believes that the Mark II / Mark III Manometric Perfusion Pump products are safe and effective when used as instructed by knowledgeable and trained personnel, and perform as well as or better than the legally marketed predicate devices."

Therefore, a table of acceptance criteria and reported device performance cannot be generated with quantifiable metrics from this document. The acceptance criteria appear to be centered around equivalence to a predicate device and adherence to recognized safety standards.

Study Information

The document explicitly states:

"The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

Given this statement, most of the requested information about studies (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) is not applicable or cannot be extracted.

Here's what can be inferred or explicitly stated:

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

   • Not applicable. No clinical test set was used for this 510(k) submission.

2. 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. No clinical test set requiring expert ground truth was used.

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

   • Not applicable. No clinical test set requiring adjudication was used.

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. An MRMC study was not done. This device is a perfusion pump, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is hardware, a Manometric Perfusion Pump, not an algorithm.

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

   • Not applicable. No clinical studies were conducted, so no ground truth was established from patient data. The "ground truth" for this submission was primarily adherence to recognized standards and demonstrated equivalence to a predicate device through engineering and risk management.

7. The sample size for the training set:

   • Not applicable. No machine learning or AI model was involved, so no training set was used.

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

   • Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary of the basis for substantial equivalence for this device:

The manufacturer established substantial equivalence by:

• Comparing the device to a predicate device (K980946 - Mark II / Mark II CO2 Flush Manometric Perfusion Pump).
• Demonstrating compliance with recognized standards (IEC 601-1 and IEC 601-1-2 for medical electrical equipment safety and EMC).
• Implementing a rigorous risk management program to eliminate or mitigate health hazards.

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Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of adults, children & infants with proven or suspected gastrointestinal motor disorders.

Dentsleeve Manometric Assemblies are designed for the monitoring and analysis of gastrointestinal pressures. They are designed to be used in conjunction with a low compliance manometric perfusion pump. The major structures of the Manometric Assemblies is a multi-channeled, medical grade, silicone rubber extrusion.

The Assemblies are designed with variations in length and channel number (depending on the extrusion and application) to enable precise low compliance pressure measurement from most areas of the GI tract. When attached to a manometric perfusion pump, a constant flow of perfused into the assembly and into the GI tract of the patient provided the perfusion pump is correctly operated. When the pressure changes within the GI tract the pressure is transferred faithfully up the assembly and detected with external pressure transducers mounted on the manometric perfusion pump.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Dentsleeve Manometric Assemblies:

Unfortunately, the provided text does not contain the detailed information required to fill out a complete table of acceptance criteria and reported device performance, nor does it describe a specific study proving the device meets acceptance criteria in the way a typical medical device validation study report would.

The document is a 510(k) submission summary and an FDA clearance letter for a medical device (Dentsleeve Manometric Assemblies). These documents focus on establishing substantial equivalence to a predicate device rather than presenting a detailed, standalone study with specific performance metrics and statistical analyses against pre-defined acceptance criteria.

However, based on the provided text, we can infer some aspects and highlight what is missing:

Inferred Information and Missing Details

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for a Comprehensive Table:

• Specific quantitative performance metrics: What defines "precise" pressure measurement? What are the tolerance limits for accuracy, drift, or signal-to-noise ratio? How were these measured?
• Detailed results for biocompatibility and sterilization: The document states testing was done, but doesn't provide the actual results or how they were compared against specific acceptance thresholds (e.g., cytotoxicity index, material integrity post-sterilization).
• Clinical effectiveness measures: While the device measures pressure, the document doesn't detail how well these measurements aid in patient management or diagnosis compared to other methods. This is often the focus of performance studies.

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

• Sample Size for Test Set: Not specified. The document only states "The Manometric assemblies have been tested for biocompatibility, functionality and ability to be sterilized..." without detailing the sample size for these tests (e.g., number of catheters tested, number of sterilization cycles for each, number of in-vitro pressure tests).
• Data Provenance: Not explicitly stated regarding the tests themselves. The company, Dentsleeve Pty Ltd, is located in Parkside, South Australia, so testing was likely conducted in Australia or by a contract lab. The document does not specify if the testing involved human subjects (prospective clinical study) or was entirely bench/lab-based (retrospective on manufactured components). Given the nature of a 510(k) for this type of device, most of the "testing" would likely be bench testing for functionality, biocompatibility, and sterilization, rather than large-scale clinical trials.

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

• Not Applicable / Not Mentioned: This type of information is typically relevant for studies involving "ground truth" established by human interpretation (e.g., radiology image interpretation). For a device that measures physical parameters like pressure, "ground truth" would be established by validated reference instruments or physical standards, not human experts. For example, pressure accuracy would be assessed against a calibrated pressure manometer.

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

• Not Applicable / Not Mentioned: Similar to point 3, adjudication methods are used to resolve disagreements among human experts when establishing ground truth. This is not pertinent to the type of bench testing described for the Dentsleeve Manometric Assemblies.

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 is a manometric assembly, a physical device for measuring pressure, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant to this product.

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

• Not Applicable: This is not an algorithmic or AI device. It's a physical catheter. Standalone performance for this device would refer to its inherent physical properties and measurement capabilities, which are likely what the "functionality" testing aimed to assess.

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

• Inferred: Bench Test Standards / Reference Devices: For functionality, the ground truth would have been established using calibrated pressure measurement equipment and physical standards. For biocompatibility, it would be based on ISO standards for medical device biocompatibility testing. For sterilization, it would involve microbiological testing against sterility assurance levels.

8. The sample size for the training set

• Not Applicable: This device does not have a "training set" in the context of machine learning or AI. It's a physical medical device.

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

• Not Applicable: As above, there is no training set.

Summary of what the document focuses on:

The provided text from the 510(k) submission and FDA letter primarily focuses on:

• Describing the device and its intended use.
• Highlighting material properties (silicone for flexibility, reduced discomfort, heat tolerance for autoclaving).
• Stating that biocompatibility, functionality, and sterilization testing were done (referencing attachments that are not provided).
• Mentioning a Risk Assessment and FMECA (also referencing an attachment not provided).
• The FDA letter confirms "substantial equivalence" to a predicate device, which is the core of a 510(k) clearance, implying that prior testing demonstrated it meets the same safety and effectiveness standards as previously cleared devices.

To obtain the specific details requested, one would need to access the full 510(k) submission attachments (A, B, C, and D) which are referenced in the provided text.

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When used in conjunction with a gastrointestinal manometric assembly (catheter), the Mark II CO2 Manometric Perfusion Pump & Mark II Manometric Perfusion Fump, can be used where gastrointestinal manometry is indicated when the following conditions are satisfied;

1. When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastro-intestinal motility.

2. Contra-indications are considered, and the risk-bencht analysis is judged to favour performance of the manometric study, after measures have been taken to minimise all possible risks.

The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are gas powered perfusion pumps designed to facilitate the monitoring and analysis of intragastrointestinal pressures. The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are comprised of a constant gas pressure delivery system and a constant flow constant pressure, multi-channel, perfusate system with the capacity to connect pressure transducers for monitoring intragastrointestinal pressures. The Mark II CO2 Flush Manometric Perfusion Pump has an addition CO2 gas circuit for facilitating the removal of air bubbles from the perfusate circuit prior to it clinical use. Both Manometric Perfusion Pump have been designed to be compatible with gastrointestinal motility catheters.

The provided text describes a medical device, the "Mark II Manometric Perfusion Pump" and "Mark II CO2 Flush Manometric Perfusion Pump," and its substantial equivalence to a predicate device. However, it does not contain explicit acceptance criteria or a dedicated study section that proves the device meets specific performance metrics in a way that can be directly extracted and tabulated as requested.

The text primarily focuses on:

• Device Description and Indications for Use: Explaining what the device is, what it does, and how it's intended to be used.
• Substantial Equivalence Claim: Stating that it's equivalent to existing devices.
• References to Prior Research: Citing scientific papers that support the concept of improved perfusion systems for manometry in general, and the benefits of pneumatically driven pumps. These are not direct studies of this specific Mark II device's acceptance criteria.

Here's an attempt to answer your questions based on the available information, with significant caveats where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• "The Mark II Manometric Perfusion Pump has been tested and shown to enable accurate intergastrointestinal pressure measurements."

This is a general statement of performance, not a specific, quantifiable "acceptance criteria" with associated "reported device performance." The references provided are for the principles behind such devices, not the a study detailing the Mark II's direct performance against quantifiable criteria.

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

Not provided. The document references scientific papers, but these are not studies of the Mark II device's specific test set. For example, Arndorfer et al. (1977) studied a "hydraulic capillary infusion system," and Dent et al. (1977) studied a "pneumatically driven perfusion pump," neither of which are explicitly named as the "Mark II." Hebbard et al. (1997) is an abstract about high-resolution perfusion manometry generally.

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

Not provided.

4. Adjudication method for the test set

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 and Not provided. This device is a perfusion pump, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Not applicable and Not provided. This device is a mechanical perfusion pump, not an algorithm.

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

Not explicitly provided for the "Mark II" device. For the principles elucidated in the referenced papers (e.g., Arndorfer et al., 1977), the "ground truth" would likely be the accurate measurement of esophageal peristaltic pressure, which would be assessed by comparing the device's output against known physiological responses or established standards of accurate pressure measurement. However, this is inferential based on the type of device.

8. The sample size for the training set

Not applicable and Not provided. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable and Not provided. This is a hardware device, not a machine learning algorithm.

Summary of what is present:

The document serves as a 510(k) summary, aiming to demonstrate substantial equivalence to existing predicate devices (e.g., The Pneumo-Hydraulic Capillary Infusion System Arndorfer Medical Specialties). This approach often relies on demonstrating that technical characteristics are similar and that the new device does not raise new questions of safety or effectiveness, rather than providing a detailed clinical study meeting specific, quantifiable acceptance criteria for this new device. The "Testing" section is extremely brief and general ("has been tested and shown to enable accurate intergastrointestinal pressure measurements") and refers to the scientific literature that likely informed the design principles of the device rather than directly presenting the results of a specific validation study against quantitative acceptance criteria for the Mark II pump itself.

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