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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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