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Gemini Bonded 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 Bonded 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

As previously described in K143147. Gemini Bonded Sterilization Wrap is offered to the marketplace as bulk packages of two ply sheets which are ultrasonically bonded together 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. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; cutting wrap/unwrap time in half, compared to traditional doublewrapping methods.

Gemini Bonded Sterilization Wrap 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.

The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The wrap allows for aseptic opening of the sterilized package.

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

The provided text describes the acceptance criteria and study results for the "Gemini Bonded Sterilization Wrap" (K152458) by Medline Industries, Inc. The device's primary function is to enclose other medical devices for sterilization and maintain their sterility until use.

The submission is a Traditional 510(k) and asserts substantial equivalence to a predicate device, Gemini Bonded Sterilization Wrap cleared under K143147.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size for the test set" in terms of number of wraps tested for each validation. The validation studies for sterilization efficacy likely involved multiple cycles and packages to demonstrate repeatable results.

• Data Provenance: The studies appear to be internal validation studies conducted by or for Medline Industries, Inc. The document does not specify a country of origin for the data beyond the company's location in Mundelein, IL, USA. The studies are prospective as they were conducted to validate the device's performance for this 510(k) submission.

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

This information is not provided in the document. For device validation studies like sterilization wraps, "ground truth" would typically be established through microbiology lab results (sterility testing, biological indicator kill) and physical testing according to relevant standards. These processes usually involve trained laboratory personnel rather than clinical "experts" like radiologists.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation (e.g., image reading), not for laboratory or performance testing of a physical product like a sterilization wrap.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. This device is a sterilization wrap, not an AI or diagnostic imaging device that involves human interpretation.

6. Standalone Performance Study

Yes, standalone performance was conducted for the device. The "Summary of Non-Clinical Testing" (Table 8 and subsequent paragraphs on page 13) describes various performance tests performed on the Gemini Bonded Sterilization Wrap. These tests evaluate the wrap's physical properties, sterilant penetration, and ability to maintain sterility without human intervention during the sterilization or storage phases.

7. The Type of Ground Truth Used

The ground truth used for this device's validation is primarily based on technical performance standards and objective measurements:

• Sterility: Absence of microbial growth after sterilization, typically confirmed through biological indicators and sterility testing.
• Physical Properties: Measurable values for air permeability, basis weight, burst strength, water penetration resistance, tensile strength, elongation, and tear strength, compared against predefined specifications and industry standards (e.g., ASTM, AATCC).
• Biocompatibility: Absence of adverse biological reactions (e.g., skin irritation) as tested against ISO 10993-10 standards.
• Shelf Life: The ability of the package to maintain sterility over a specified period, verified through real-time stability studies which likely involved package integrity testing and sterility checks over time.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are relevant for machine learning or AI models. This device is a physical product, and its performance is validated through traditional engineering and scientific testing, not by training an algorithm.

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

As the concept of a training set is not applicable, the method for establishing its ground truth is also not applicable.

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Gemini Bonded Sterilization Wrap is 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 for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.

• Pre-vacuum steam cycles
  • Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
• Gravity steam cycles
  • Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time
• STERRAD® Sterilization
  • STERRAD® 100NX, Flex cycle
  • STERRAD® 100NX, Standard cycle
  • STERRAD® 100NX, Express cycle
  • STERRAD® 100S. Standard cycle
  • STERRAD® NX, Advanced cycle
  • STERRAD® NX, Standard cycle

Gemini Bonded Sterilization Wrap is comprised of two ply sheets ultrasonically bonded together 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 Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; reducing wrapping/unwrapping time significantly compared to traditional double-wrapping methods. Gemini Bonded Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbondspunbond-meltblown-meltblown-spunbond) process. The standard blue wrap fabric is made of polypropylene with the addition of blue and white pigmentation. The wrap allows for aseptic opening of the sterilized package. The two-tone blue/pink wrap fabric is made of polypropylene with the addition of blue, white and red pigmentation. The wrap allows for aseptic opening of the sterilized package. Gemini sterilization wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.

The provided text describes the acceptance criteria and the study that proves the Gemini Bonded Sterilization Wrap meets these criteria.

Here's the breakdown:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the numerical sample size for the test set for each specific sterilization or biocompatibility test. It lists the types of loads used for sterilization validation studies, which could be considered the "test samples" in these evaluations.

• Sterilization Validation Studies:
  • Pre-vacuum steam and gravity steam: Various loads were used, described by components (e.g., "2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes", "16 huck towels... 5 lbs of metal mass"). The exact number of times each load/wrap combination was tested is not provided.
  • Advanced Sterilization Products (ASP) STERRAD 100S: Various loads using "15 in. x 10 in. x 1.2 in. tray containing metal instruments" for different weight categories.
  • Advanced Sterilization Products (ASP) STERRAD NX and STERRAD 100NX: Various loads using "23 in. x 11 in. x 4 in tray containing metal instruments" for different weight categories.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a premarket notification for the FDA, it is highly likely that the testing was performed prospectively as part of product development and validation for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies listed are laboratory-based performance tests (material barrier, irritation, sterilization efficacy), not studies requiring expert interpretation of clinical data or images.

4. Adjudication method for the test set

This information is not applicable as the studies are laboratory-based performance tests, not studies requiring human interpretation or adjudication of results.

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

This information is not applicable. The device is a sterilization wrap, not an AI-assisted 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

This information is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. The type of ground truth used

The ground truth for the performance validation is based on:

• Established standards and specifications: ISO 10993-10 for biocompatibility, ISO 11607-1 and ASTM F1980 for microbial barrier properties.
• Sterility Assurance Level (SAL): While not explicitly stated as a numerical SAL, sterilization efficacy studies inherently use biological indicators or other methods to demonstrate a certain level of sterility (e.g., 10^-6), which serves as the "ground truth" for successful sterilization. The text states the wrap "maintains sterility of such content for 180 days following sterilization," implying successful sterility testing.
• Physical and chemical measurements/observations: Tests for skin irritation involve biological response observation against established criteria. Microbial barrier properties involve challenging the material with microbes and demonstrating its effectiveness. Sterilization cycle validations involve verifying the eradication of microbes under specific conditions.

8. The sample size for the training set

This information is not applicable. The device is a physical product and does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

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