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Opportunity Inc.'s Suture Removal Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing suture removal.

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The provided documents are FDA 510(k) clearance letters for various medical kits, including the "Opportunity Suture Removal Kit." This type of document is a notification of intent to market a device based on its substantial equivalence to a legally marketed predicate device.

These documents indicate that the FDA determined substantial equivalence based on a review of the company's submission, but they do NOT contain information on specific acceptance criteria, device performance studies, or the methodologies listed in your request.

The FDA 510(k) clearance process primarily evaluates whether a new device is as safe and effective as another legally marketed device, often without requiring new clinical trials or detailed performance studies in the same way a Premarket Approval (PMA) would. The manufacturer would have provided information demonstrating substantial equivalence to a predicate device, which would include descriptions of the device's components and intended use.

Therefore, I cannot provide the requested information because it is not present in the provided FDA clearance letters. The document 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 to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of Act." This indicates a regulatory review based on equivalence, not detailed performance studies against pre-defined acceptance criteria.

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Opportunity Inc.'s Dressing Change Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing in the change of dressings.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Opportunity, Inc. regarding several medical device kits and trays. It primarily addresses the substantial equivalence determination for these devices, regulatory classifications, and general compliance requirements.

Therefore, I cannot provide the requested information in the structured format.

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Opportunity Inc.'s Incision and Drainage Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing incision and drainage procedures.

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This document is a 510(k) premarket notification decision letter from the FDA, not a study report. It states that the referenced devices (various medical trays and kits) are "substantially equivalent" to devices marketed before May 28, 1976. Substantial equivalence is a regulatory finding, not an assessment of device performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from this document. The document confirms that Opportunity Inc. can market its devices based on their substantial equivalence to existing products, but it does not contain data on device performance or a study demonstrating such performance.

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Opportunity Inc.'s Laceration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing laceration procedures.

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I'm sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. This appears to be a 510(k) clearance letter from the FDA for a set of medical kits and trays, primarily focusing on regulatory compliance and substantial equivalence to previously marketed devices. It does not detail specific performance studies or acceptance criteria for the devices themselves.

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Opportunity Inc.'s Tracheostomy Care Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing tracheostomy procedures.

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This document is a 510(k) clearance letter from the FDA for several medical kits, including the "Opportunity Tracheostomy Care Kit." It primarily addresses regulatory aspects and does not contain information about the acceptance criteria, study details, or performance of a specific device in the context of a clinical or performance study.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include studies related to the device's efficacy or performance characteristics with specific metrics.

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Opportunity Inc.'s I.V. Start Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing I.V. start procedures.

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I cannot fulfill this request. The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for various medical kits, including an "Opportunity I.V. Start Kit." This type of document declares a device substantially equivalent to a predicate device already on the market, allowing it to be marketed.

However, a 510(k) clearance letter does not contain details about acceptance criteria or specific study results for device performance, especially in the context of advanced AI models. The text focuses on regulatory compliance, classification, and the substantial equivalence determination based on existing regulations and predicate devices.

Therefore, the information needed to answer your questions (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided document.

To answer your questions, I would need a different type of document, such as a clinical study report, a scientific publication detailing the device's performance, or a more comprehensive technical submission to a regulatory body that outlines the validation studies.

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Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.

Bone Marrow Biopsy and Aspiration Tray

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a "Bone Marrow Biopsy and Aspiration Tray," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, such as good manufacturing practices, labeling, and drug components within the kit, but it does not detail performance metrics or studies performed to prove the device meets specific acceptance criteria.

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Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.

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The provided document is an FDA 510(k) clearance letter for a "General Purpose Tray" and does not contain information about the acceptance criteria, device performance, or study details as outlined in the request. The letter only states that the device is substantially equivalent to legally marketed predicate devices and addresses regulatory aspects such as labeling, drug components, and general controls.

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

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