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The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers are provided nonsterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (prevacuum, 270°F, 4 minutes with 40 minutes drying time).

Lac-Mac Ltd. 84E Series Single Ply Wrapper

This document is a 510(k) clearance letter from the FDA for a medical device called "Lac-Mac Ltd. 84E Series Single Ply Wrapper." It does not contain any information regarding the acceptance criteria or a study proving the device meets that criteria in the context of an AI/ML powered device.

The document grants clearance for a physical product (sterilization wrap) and primarily addresses its substantial equivalence to previously marketed predicate devices under the 510(k) pathway. This regulatory pathway is for conventional medical devices and does not involve AI/ML performance evaluation as would be required for a software-as-a-medical-device (SaMD) or an AI-enabled device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth was established for an AI/ML model.

This document is entirely irrelevant to the query about AI/ML device evaluation.

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The Lac-Mac, Ltd, Innerbloc LR Surgical Gowns are reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

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The provided text is a 510(k) clearance letter from the FDA for a surgical gown. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on:

• Confirming the substantial equivalence of the Lac-Mac, Ltd, Innerbloc LR Surgical Gowns to legally marketed predicate devices.
• Outlining the regulatory requirements and responsibilities of the manufacturer.
• Stating the intended use of the surgical gowns.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document as it pertains to the evaluation of a medical device's performance against specific metrics.

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The Lac-Mac, Limited, InnerBloc® OR Surgical Gowns, based on the RePel Plus™ and GORE® Color Survice of the Art in the cours that are intended to be worn by health care The Lac-Mac, Limited, InnerBiolo OK Surgical Or his asse intended to be wort by health care LP Surgical Goven Pabric materials, are protect both the surgical patient world the operating room personnel from transfer of microorganisms, body filish, and patitulate matterial. For personnel from fransfer of of microolgamisms, "oody" history and processed and packaged.

Lac-Mac, Limited, InnerBloc™ OR Surgical Gown

The provided text describes a 510(k) premarket notification for a surgical gown and does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI-powered medical device. The document is a regulatory approval letter from the FDA for a physical product (surgical gown), not a software or AI device.

Therefore, I cannot provide the requested information. The text does not discuss:

• Acceptance criteria for an AI device's performance.
• A study related to AI device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth.
• How ground truth was established for a training set.

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The Lac-Mac, Limited, InnerBloc® LR Surgical Gowns, based on the GORE® LR Fabric, are reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

This document is an FDA 510(k) clearance letter for a surgical gown, not a study report for a medical device that uses AI or performs diagnostic tasks that would typically require acceptance criteria based on performance metrics like sensitivity, specificity, etc.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to performance metrics for a diagnostic or AI-driven device.

The document is a regulatory approval for a physical product (surgical gowns) based on substantial equivalence to a predicate device, which focuses on manufacturing, materials, and intended use as defined by existing regulations. It does not involve performance studies with test sets, ground truth, expert adjudication, or MRMC studies.

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The Lac-Mac Limited InnerBloc® O.R. Drapes based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, are reusable protective patient coverings for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Lac-Mac Limited InnerBloc® Various O.R. Drapes based on the RePeL PLUSTM and Gore® Surgical Barrier Fabric Materials

The provided text is a 510(k) premarket notification letter from the FDA to Lac-Mac Limited regarding their InnerBloc® O.R. Drapes. This document does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI device.

The document is a regulatory approval for a physical medical device (surgical drapes) and focuses on substantial equivalence to predicate devices, general controls, and compliance requirements. It predates widespread AI in medical devices and therefore, does not address any of the requested AI-specific information.

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

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The Lac-Mac Limited InnerBloc® O.R. Gowns based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, are reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

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

The provided document is a 510(k) premarket notification letter from the FDA regarding surgical apparel (reusable O.R. gowns). It does not contain information about acceptance criteria, study details, or performance metrics for a device in the context of AI or diagnostic accuracy studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance data from a clinical or technical study.

Ask a specific question about this device