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The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The pouches are manufactured from a medical grade paper that is thermally sealed to a laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The pouches contain external indicators used to indicate the pouches were processed via steam or EO sterilization.

The provided text describes the 510(k) summary for the Medicom Self Sealing – Sterilization Pouch. This device is a sterilization pouch with external chemical indicators, not an AI/ML-driven medical device for diagnosis or treatment. Therefore, the questions related to clinical studies, human readers, ground truth, and training sets for an AI/ML model are not applicable to this submission.

However, I can extract information related to the device's acceptance criteria and how its performance was evaluated for substantial equivalence.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a "Comparison Testing" and "Substantial Equivalence" assessment against a legally marketed predicate device, the Winner® Self Seal Sterilization pouch (K051242), and relevant recognized standards, specifically ISO 11140-1:2005 for chemical indicators.

Non-Applicability for AI/ML Specific Questions:

The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (sterilization pouch) and not an AI/ML diagnostic or therapeutic algorithm:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" refers to physical samples of the device and predicate, not data for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, in the context of AI/ML ground truth. For this device, "ground truth" would be the verified performance of the predicate device and compliance with established ISO standards for physical characteristics and chemical indicator performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Device Evaluation Approach:

The evaluation of the Medicom Self Sealing Sterilization Pouch for 510(k) clearance relied on demonstrating substantial equivalence to a predicate device. This was achieved through:

• Side-by-side testing: Comparing the new device directly with the predicate (Winner® Self Seal pouch) across several key performance parameters including:
  • Sterilant Penetration
  • Drying Time
  • Aeration
  • Biocompatibility
  • Package Integrity
• Compliance with recognized standards: Specifically, the chemical indicators were evaluated against ISO 11140-1:2005 for efficacy.
• Material Compatibility: Shown to be equivalent to the predicate.
• Sterility Maintenance: The intended use statement claims sterility maintenance for up to one year, which would typically be supported by accelerated or real-time aging studies and microbiological challenge tests, the specifics of which are not detailed in this summary but are implicit requirements for such a claim.

The 510(k) summary indicates that these comparisons and compliance demonstrations were sufficient for the FDA to determine substantial equivalence and allow the device to be marketed.

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The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

The new surgical masks are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% medical grade tissue paper or 100% SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices.

The device in question is a Non-Sterile Surgical Mask manufactured by A.R. Medicom Inc. The filing is a 510(k) Summary, indicating a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the traditional sense of AI/medical imaging device performance.

Therefore, the "acceptance criteria" for a surgical mask are typically based on recognized performance standards, which in this case is ASTM F2100-04, "Standard Specification for Performance of Materials Used in Medical Face Masks." The "study" that proves the device meets these criteria would involve various material and barrier property tests, not a clinical trial with human readers or AI.

Given the nature of the device (a surgical mask) and the provided document (a 510(k) Summary for a medical device cleared in 2005), many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, AI standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/software as a medical device or diagnostic imaging devices, not a physical barrier device like a surgical mask.

However, I will address the relevant aspects based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For surgical masks, "acceptance criteria" and "reported device performance" are typically defined by recognized consensus standards. In this case, ASTM F2100-04 is listed as the recognized performance standard. This standard categorizes masks into different levels based on their performance in a series of tests. While the exact performance levels for this specific mask are not detailed in the provided 510(k) summary (only the standard itself is mentioned as being applicable), the various tests and their criteria from ASTM F2100-04 are implied to be the 'acceptance criteria'.

The 510(k) summary states that the device is "substantially equivalent" to predicate devices K955513 and K040333, implying it meets similar performance standards. The device's description (3-ply, spun-bound polypropylene outer layers, melt-blown polypropylene filter media, medical grade tissue paper or SBPP inner layer) strongly suggests the materials are chosen to meet these performance characteristics.

Note: The 510(k) summary explicitly refers to "ASTM 2100-04" as a "Recognized Performance Standard" and states that "Refer to Appendix B for a list of applicable standards." This indicates that the device's performance was evaluated against the requirements of this specification, and thus it meets the stated performance levels defined within ASTM 2100-04 for surgical masks. Without Appendix B or the full testing report, the exact numerical performance values (e.g., a specific BFE percentage) are not detailed in this summary.

Study that Proves the Device Meets the Acceptance Criteria:

The filing is a 510(k) summary, which indicates a submission to demonstrate substantial equivalence to existing legally marketed devices, rather than a novel study designed to establish acceptance criteria for an entirely new technology. The "study" here refers to the collection of data and tests (likely in-vitro and material property tests) performed to show that the surgical mask complies with the recognized performance standard ASTM F2100-04 and is substantially equivalent to the predicate devices.

The evidence for meeting acceptance criteria is typically derived from laboratory testing of the mask materials and design according to the methods prescribed by the ASTM F2100-04 standard. These tests would evaluate parameters such as bacterial filtration efficiency, particle filtration efficiency, fluid resistance, breathability, and flammability. The results of these tests, when compared against the thresholds defined in ASTM F2100-04, demonstrate compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the 510(k) summary. For material performance tests like those required for surgical masks, sample sizes are typically determined by the testing methodology outlined in the relevant ASTM or ISO standards to ensure statistical validity for the specific tests (e.g., multiple masks or multiple samples from a mask might be tested for each parameter).
• Data Provenance: Not explicitly stated, but the manufacturer is A.R. Medicom Inc., located in Lachine, Quebec, Canada. Testing would likely be conducted at certified laboratories, either internal or third-party, which may be in Canada or elsewhere. The nature of these tests is not "retrospective" or "prospective" in the clinical trial sense, but rather laboratory-based characterization.

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

Not applicable. For a physical barrier device like a surgical mask, "ground truth" is not established by clinical experts in the way it is for diagnostic imaging or AI devices. The "ground truth" is based on objective, quantifiable measurements from standardized laboratory tests (e.g., the measured bacterial filtration efficiency percentage). The "experts" involved would be laboratory technicians and engineers experienced in conducting ISO/ASTM standard tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting medical images or clinical data. This is not relevant for the performance testing of a surgical mask.

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. MRMC studies are used to evaluate the diagnostic performance of human readers, often with and without AI assistance, typically in medical imaging. This is not relevant for a surgical mask.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to the evaluation of an AI algorithm's performance without human interaction. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for a surgical mask's performance is established by objective measurements from physical property tests conducted according to recognized standards (e.g., ASTM F2100-04). Examples include:

• Bacterial Filtration Efficiency (measured percentage)
• Particle Filtration Efficiency (measured percentage)
• Fluid penetration resistance (measured pressure in mmHg)
• Differential pressure (measured value in mm H2O/cm²)
• Flammability (classification per standard test)

These are empirical facts determined by standardized test methods, not subjective consensus or clinical outcomes from patients.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model that requires a "training set."

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

Not applicable. As above, there is no training set for this type of medical device.

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