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The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.

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This document is an FDA 510(k) clearance letter for the X-TIP Intraosseous Perforator. It primarily addresses the regulatory approval process and states the device's intended use. It does not contain any information regarding specific acceptance criteria for device performance or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The letter only confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail performance data or studies.

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The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.

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Based on the provided text, the document is a 510(k) clearance letter for the "Jostra Venous Hardshell Cardiotomy Reservoir VHK 4200." This document primarily addresses regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria for an AI/ML powered medical device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially in the context of AI/ML devices) is not available in the provided text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or test sets.
3. Details on experts used for ground truth, adjudication methods, or ground truth types.
4. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Details on training set sample size or how ground truth for training was established.

The document asserts that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than presenting a de novo performance study against new acceptance criteria.

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For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.

Nutrisafe® Enteral Feeding Tube

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Vygon Nutrisafe Enteral Feeding Tube". This type of document primarily confirms that a device is substantially equivalent to a predicate device already on the market and can be legally marketed. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the way described in your request (e.g., performance metrics like sensitivity, specificity, or AUC, and details about study design).

Therefore, I cannot extract the requested information from the provided text because it is not present. The letter focuses on regulatory clearance, not a performance study report.

To answer your questions, I would need a document that presents the results of a performance study for the device, including:

1. A table of acceptance criteria and the reported device performance: This would typically list metrics like tensile strength, flow rate, biocompatibility testing results, etc. against predefined acceptance limits.
2. Sample size used for the test set and the data provenance: Details on how many tubes were tested, where the materials came from, and if the testing was prospective (designed for the device) or retrospective (using existing data).
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): This is highly relevant for AI/imaging devices but unlikely for a physical medical device like an enteral feeding tube. For physical devices, ground truth is usually established through validated measurement methods or established standards.
4. Adjudication method: Again, more relevant to diagnostic interpretations than physical device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a physical feeding tube. This is for AI-powered diagnostic tools comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical feeding tube.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a feeding tube, this would likely be physical measurements, chemical analyses, or biocompatibility tests.
8. The sample size for the training set: Not applicable for a non-AI physical device.
9. How the ground truth for the training set was established: Not applicable for a non-AI physical device.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed performance study information you are asking for.

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Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.

Double Lumen Umbilical Catheter

This document is a 510(k) clearance letter from the FDA for a medical device called the "Vygon Double Lumen Umbilical Catheter" (K981630). It is a regulatory approval document and not a scientific study report.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document. This letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not provide the specific performance data or the study design used to make that determination.

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Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Plus Reusable Resuscitator" and primarily discusses the regulatory approval and substantial equivalence to a predicate device. It indicates the device's intended use but does not detail acceptance criteria, performance data, study designs, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or device performance evaluation.

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Ask a specific question about this device

Ask a specific question about this device