(29 days)
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:
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. No machine learning or AI model was involved, so no training set was used.
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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.
§ 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).