(87 days)
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;
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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.
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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.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).