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Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles: STERIS V-PRO® Low Temperature Sterilization Systems (STERIS V-PRO® 60, STERIS V-PRO® 1, STERIS V-PRO® 1 Plus, STERIS V-PRO® maX) and STERIZONE® VP4 Sterilization System.

Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded sheets of wrap for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The bonded wrap is comprised of two sheets of Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously.

Gemini Sterilization Wrap items are square or rectangular sheets of non-woven fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.

The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wraps are offered in 3 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. Also, some wraps contain titanium dioxide and others do not.

The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The two-tone blue/pink wraps are offered in 3 different shades of blue and pink that vary in the amount of phthalocyanine, disazocondensation red and titanium dioxide depending on the weight of the wrap.

Gemini Sterilization Wrap is available in sizes ranging from 12" x 72" across five different material weights/models listed below.

The provided text is a 510(k) premarket notification for a medical device (Gemini Sterilization Wrap) and does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

Instead, it details the substantial equivalence of the Gemini Sterilization Wrap to a predicate device based on physical and sterilization performance testing. The "performance studies" mentioned (Tables 4 and 5) evaluate the physical properties of the wrap (e.g., tensile strength, tear strength, hydrostatic pressure, air permeability) and its ability to maintain sterility and allow sterilant penetration. They also include biocompatibility testing.

Therefore, I cannot extract the information required for the requested table and study details (sample size, data provenance, expert ground truth, MRMC study, training set details) as they pertain to an AI/ML device, because this document describes a physical medical device.

To directly answer your prompt based on the provided document, I must state that the document does not contain the information required to populate the fields related to AI/ML device studies.

Here's why and what the document does provide:

• No AI/ML information: The entire document is about a physical sterilization wrap. There is no mention of algorithms, machine learning, AI, image analysis, or any computational aspect.
• Device Type: Gemini Sterilization Wrap is a non-woven fabric used for packaging medical devices for sterilization.
• Acceptance Criteria & Performance: The document lists various non-clinical performance studies (Tables 4 & 5) and states they "Passed." These are the "acceptance criteria" and "reported device performance" in the context of this physical device.
  • Acceptance Criteria (implicit by "Passed"): The wrap must:
    • Maintain sterility.
    • Allow sterilant penetration.
    • Meet specified tensile breaking strength and elongation (ASTM D5034).
    • Meet specified tear strength (ASTM D5587).
    • Meet specified hydrostatic pressure (AATCC 127).
    • Meet specified burst pressure (ASTM D3786 - for V-PRO 60 only).
    • Meet specified air permeability (ASTM D737).
    • Pass post-sterilization biocompatibility (Cytotoxicity – ISO 10993-5).
    • Pass post-sterilization biocompatibility (Primary Skin Irritation Testing – ISO 10993-10).
• Study Proving Acceptance: The document summarizes non-clinical performance testing for both V-PRO® 60 and Sterizone VP4 sterilization systems for various Gemini Wrap models.

Therefore, the requested table and answers regarding AI/ML specifics cannot be generated from this document.

If this were an AI/ML device, the missing information would typically include details like:

• Sample size for test set: Number of images/cases used to evaluate the AI.
• Data provenance: Where the data came from (e.g., specific hospitals, demographics, geographical regions), and if it was collected retrospectively or prospectively.
• Experts for ground truth: How many experts reviewed the data to determine the "correct" labels/diagnoses.
• Qualifications of experts: Their specialties, years of experience, board certifications.
• Adjudication method: How disagreements among experts were resolved (e.g., 2 out of 3, a super-expert, discussion).
• MRMC study: If human performance with and without AI assistance was compared.
• Effect size: The quantifiable improvement in human performance with AI.
• Standalone performance: The AI's performance without human interaction.
• Type of ground truth: Whether it was based on expert consensus, pathology reports, clinical outcomes, etc.
• Training set size: The number of images/cases used to train the AI model.
• Training set ground truth: How the labels/ground truth for the training data were established.

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Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:

TABLE 1: Pre-vacuum team at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
TABLE 3: STERRAD® Sterilization

Gemini Sterilization Wrap is offered to the marketplace as bulk packages of single ply sheets for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collection of medical devices are wrapped.

Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.

The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wrap allows for aseptic opening of the sterilized package.

Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x90" across the five different material weights/models.

Below is a summary of the acceptance criteria and study information for the Gemini Sterilization Wrap based on the provided FDA 510(k) summary (K152564).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing conducted and states whether the device "Passed" each test. The acceptance criteria are implicitly met by passing these tests, demonstrating substantial equivalence to the predicate device and suitability for its intended use.

Note: For the material characteristic tests (Air permeability, Basis weight, etc.), the document states these tests were conducted and then concludes "The safety and effectiveness...is adequately supported..." which implies they passed relevant acceptance criteria for those standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes used for each test. It refers to "real time stability studies" for shelf life and other performance tests.

• Sample Size for Test Set: Not explicitly stated as specific numbers of wraps or sterilization cycles.
• Data Provenance: The document does not specify the country of origin. The studies are described as "real time stability studies" and "performance testing," which implies prospective testing conducted for the purpose of the 510(k) submission. There is no indication of retrospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the evaluation of a sterilization wrap. The performance evaluation relies on objective physical and microbial barrier testing in controlled laboratory environments, not subjective expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable, as this is related to expert review of subjective data, which is not relevant for this device's testing.

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

Not applicable. This is a medical device (sterilization wrap), not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the Gemini Sterilization Wrap is established through standardized physical tests and challenge tests (e.g., sterilization penetration, package integrity, material properties, biocompatibility) designed to objectively evaluate the device's ability to maintain sterility and withstand sterilization processes. This is based on established scientific principles and industry standards (e.g., ASTM, AATCC, ISO 10993-10).

8. The Sample Size for the Training Set

Not applicable. There is no AI component or machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI component or machine learning model.

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The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.

The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.

Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded sheets of wrap for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The bonded wrap is comprised of two sheets of the Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously. The wrap allows for aseptic opening of the sterilized package.

Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.

The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wraps are offered in 5 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. The lightest weight wrap has the least amount of blue pigment and the super heavy weight has the highest amount. Also, some wraps contain titanium dioxide and others do not.

Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.

This document describes the premarket notification (510(k)) for the Medline Gemini Sterilization Wrap. However, the provided text does not contain information about a study that assesses a device's performance against detailed acceptance criteria for an AI/CADe device, nor does it involve human readers improving with AI assistance, ground truth establishment by experts, or training/test sets as would be typical for such a device.

The document is for a medical device (sterilization wrap) which is evaluated based on its ability to maintain sterility and its physical properties. The testing described is primarily bench testing and biocompatibility testing, not clinical performance or AI algorithm validation.

Therefore, I cannot fulfill your request using the provided input, as the information required for an AI/CADe device's acceptance criteria and study proving its performance against those criteria is simply not present in this regulatory submission for a sterilization wrap.

To provide a descriptive answer, the input must be a regulatory document for an AI/CADe device, or a device that involves image analysis, diagnosis, or has a human-in-the-loop component with AI assistance.

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