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The surgical drape is used as a protective patient covering such as to isolate a side of surgical incision from microbial and other contamination.

Fanfold Drape (Surgical Drape) 41"x57"

The provided text is a letter from the FDA to Customed, Incorporated regarding their Fanfold Drape (Surgical Drape) - Product No. 900-633. This letter is a 510(k) clearance, indicating that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is solely a regulatory clearance document.

Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is typically found in a detailed device validation report or a clinical study report, not in a 510(k) clearance letter.

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Surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and personnel from transfer of microorganisms, body fluids and particulate material.

Surgeon's Gown, Poly Reinforced, Large

The provided text is a 510(k) clearance letter from the FDA for a Surgeon's Gown. This letter indicates that the device has been determined to be substantially equivalent to previously marketed devices. However, it does not contain any information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested table and details because the source document does not contain this type of information. The FDA 510(k) clearance process, especially for devices like surgical gowns, often relies on demonstrating substantial equivalence to pre-amendment devices or previously cleared predicate devices without necessarily requiring novel performance studies with detailed statistical metrics, ground truth, or expert adjudication as would be seen for complex diagnostic or AI-driven devices.

The letter focuses on regulatory compliance and the substantial equivalence determination based on the device's intended use (surgical apparel to protect from transfer of microorganisms, body fluids, and particulate material). It doesn't elaborate on the specific tests or their results that would prove this protection in a quantifiable manner, beyond likely referring to industry standards that the gown meets.

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The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.

The Customed Blood Collection Kits are an assembly of medical products within a pouch. The medical products are disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the kit are commonly used for blood specimen collection and Customed is not claiming or causing new uses through the intended use of the kit.

The provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) summary for a Customed Blood Collection Kit. It focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving performance against specific acceptance criteria through a study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned. Consequently, no reported device performance against such criteria is provided.
• Sample Size for Test Set and Data Provenance: No test set is described, as no study was performed to evaluate the device's performance against criteria.
• Number of Experts and Qualifications: Not applicable, as no ground truth establishment for a test set is discussed.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: The document explicitly states: "No clinical evaluations were completed." Therefore, no MRMC study was conducted.
• Standalone Performance Study: The document explicitly states: "No clinical evaluations were completed." This implies no standalone (algorithm-only) performance study was done either.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification.
• Predicate Device Identification: To establish substantial equivalence.
• Description of Subject Devices: Components, disposable nature, convenience for healthcare professionals.
• Intended Use: Venous blood specimen collection and transport, In-Vitro Diagnostic Use.
• Technological Characteristics: Claiming substantial equivalence in features, components, and intended use to the predicate device.

The critical statement that explains the absence of the requested information is: "No clinical evaluations were completed." This indicates that the regulatory submission for this device did not rely on performance studies with acceptance criteria but rather on a comparison to an already legally marketed device (predicate device) based on similarity in design and intended use.

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