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The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

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This document is a 510(k) clearance letter from the FDA for a laparoscopic insufflator (HI-FLO Therme Pneu 45). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the given context.

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The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The documents are a 510(k) clearance letter and an indications for use statement for a medical device (WISAP CO2-OP-Pneu Computer). They confirm the FDA's regulatory approval but do not detail the specific performance acceptance criteria or the study data that led to this approval.

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This decice is restricted to use by authorized expert personnel / physicians!

The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO .- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

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The provided FDA document is a 510(k) clearance letter for the WISAP Therme Pneu Computer. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device. This type of document does not contain the detailed information required to answer your questions about acceptance criteria and performance studies.

The letter states: "We have reviewed your Section 510k) notification of intent to market the device and we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means that the device's clearance was likely based on a comparison to an existing device, rather than a new clinical performance study with specific acceptance criteria as you've outlined.

Therefore, I cannot provide the requested information because it is not present in the given text.

To answer your questions, one would need access to the full 510(k) submission document, which would detail any performance testing conducted, if applicable to this type of device and regulatory pathway. For many Class I and Class II devices cleared via the 510(k) pathway, extensive "acceptance criteria" and "study data" as you've described for AI/diagnostic devices are not typically required beyond demonstrating functional equivalence and safety to a predicate device.

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This device is restricted to use by authorized expert personnel/physicians.

The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.

Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES

The provided text is a 510(k) clearance letter from the FDA for a medical device: a Disposable Heating Tubing Set #7642 HSES, used with a laparoscopic insufflator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot fulfill your request for the specific details you outlined based on the given input text.

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This device is restricted to use by authorized expert personnel/physicians. The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.

The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.

This is a 510(k) premarket notification for a medical device (WISAP Power-Drive, Model #7688PD/7688PD1), which is a regulatory submission to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of document does not typically include detailed clinical study data or acceptance criteria in the way a clinical trial report or a PMA (Premarket Approval) submission would.

The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer, which would typically include technical specifications, performance testing (bench testing), and sometimes a comparison to the predicate device's features.

Therefore, most of the information requested in your prompt regarding acceptance criteria and studies proving the device meets them will not be explicitly present in this particular FDA letter or the accompanying "Indications for Use" statement. This letter is the FDA's response to the 510(k) application, not the application itself.

However, based on the nature of a 510(k) and the information provided, we can infer some details and state what is not present:

Inferred or Not Applicable Information:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in this document. For a 510(k), acceptance criteria would typically relate to demonstrating performance consistent with the predicate device, often through bench testing (e.g., cutting efficacy, torque, durability, safety features).
   • Reported Device Performance: Not detailed in this document. The manufacturer would have submitted this in their 510(k) application (e.g., results of bench tests demonstrating appropriate cutting capacity for tissue cylinders, safety features, and mechanical performance).

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

   • Not present in these documents. Given it's a laparoscopic accessory for cutting tissue, any "test set" would likely refer to engineering or bench testing, not a patient cohort in a clinical study.

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):

   • Not applicable/present. This device is a surgical instrument. "Ground truth" in this context would likely be established through engineering specifications and the physical properties of cut tissue, not expert medical interpretation of images or observations.

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

   • Not applicable/present. Adjudication is typically associated with clinical studies involving interpretation, not mechanical device performance.

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:

   • Definitely not applicable. This device is a surgical tool, not an AI-powered diagnostic or interpretive system. MRMC studies are for evaluating diagnostic accuracy, especially with imaging.

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

   • Definitely not applicable. This is a mechanical surgical device, not an algorithm.

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

   • Not explicitly stated. For a mechanical device, ground truth would likely involve measuring physical parameters (e.g., dimensions of cut tissue cylinders, precision of rotation, material properties) against engineering specifications and predicate device performance.

8. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI that would require a "training set."

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

   • Not applicable. As above.

Summary based on the provided documents:

The FDA letter indicates that the WISAP Power-Drive (Model #7688PD/7688PD1) was deemed substantially equivalent to a predicate device. This implies that the manufacturer provided sufficient evidence (likely through engineering and performance testing, and a comparison to the predicate) to satisfy the FDA that it performs as intended and is as safe and effective as the already-marketed predicate. The specific details of that evidence, including acceptance criteria and study results, are contained within the full 510(k) submission, not in this response letter or the indications for use.

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This device is restricted to use by authorized expert personnel/physicians.

The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.

Aqua-Purator Biotherme 1608

The provided text is a 510(k) clearance letter for the WISAP Aqua-Purator Biotherm 1608 device, indicating it has been found substantially equivalent to a predicate device. However, this type of regulatory document typically does not contain the detailed study information required to fill out the requested table for acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the submission primarily focused on demonstrating equivalence to an existing device, rather than providing new clinical study data with detailed performance metrics and ground truth analysis as would be found in a new PMA (Premarket Approval) application or a more extensive de novo submission.

Therefore, the following information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: No specific performance criteria or results of a study demonstrating these are mentioned.
2. Sample size used for the test set and the data provenance: Not applicable as a formal test set with performance metrics is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an Aqua-Purator, not an AI or imaging device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document only provides:

• Device Name: Aqua-Purator Biotherm 1608
• Intended Use: "This device is restricted to use by authorized expert personnel/physicians. The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 l volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature."

To obtain the detailed study information, one would typically need to review the full 510(k) submission, which is not publicly available in its entirety in this format, or look for predicate device information if specific performance claims were being made in comparison.

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