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The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

• Crosstex® Isolite® Earloop Face Masks Blue, Pink .
• Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
• Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
• Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
• Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
• Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue ●
• Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue

The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of medical grade tissue or 100% spunbonded polypropylene, a 100% facing of mediour grade tiesas of Tea, with white elastic loops and/or a fogfree strip. monown performs most (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).

The provided text describes the submission for 510(k) premarket notification for Crosstex® Surgical Masks. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document states: "It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards." This indicates that the Crosstex® Surgical Masks met the acceptance criteria for each test. However, the specific quantitative acceptance criteria and the exact reported performance values are not provided in the document.

The "aforementioned test standards" refer to the non-clinical tests performed:

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

The document does not specify the sample sizes used for any of the non-clinical tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench) tests, the concept of "prospective" or "retrospective" data provenance for patient data doesn't directly apply. The data would have been generated in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The document describes non-clinical laboratory tests (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility) of a physical device (surgical masks). These tests do not involve expert interpretation or establishment of ground truth in the way a diagnostic imaging study would. The 'ground truth' for these tests is based on the objective measurements against established test standards.

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

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described are objective laboratory measurements, not subject to adjudication by experts.

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

There was no MRMC comparative effectiveness study done. The device is a surgical mask, and the evaluation involved non-clinical performance testing against established standards, not a comparison of human reader performance with or without AI assistance. This type of study is entirely irrelevant to the device under review.

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

A "standalone" performance evaluation in the context of AI refers to the algorithm's performance without human intervention. This concept is not applicable here as the device is a physical surgical mask, not an AI algorithm. The performance tests were conducted on the masks themselves, which is analogous to a "standalone" evaluation of the physical product's capabilities.

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

The "ground truth" for the non-clinical tests described is the objective measurement against the specified test standards and methodologies. For example:

• Fluid Resistance: Ground truth would be the measurable resistance to fluid penetration as defined by the Liquid (Water) Resistance Test/Impact Penetration Test standard.
• Bacterial Filtration Efficiency (BFE): Ground truth would be the measurable percentage of bacteria filtered out, according to the BFE test standard.
• Flammability: Ground truth would be the measurable flammability characteristics as defined by the flammability test standard.
• Biocompatibility: Ground truth would be the biological response (or lack thereof) observed in accordance with ISO 10993 guidelines.

It is not expert consensus, pathology, or outcomes data, as these are clinical forms of ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical medical product (surgical mask), not an AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for a physical surgical mask.

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Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.

The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:

• 2 X 2" (light) 4-Ply
• 2 X 2" (light)
• 3 X 3" (Premium) 4-Ply
• 4 X 4" (Premium) 4-Ply
  sponges used for the absorption of liquids from the patient's skin.

The provided document describes a 510(k) submission for "Crosstex Non-Woven Sponges," which are medical sponges used for absorbing fluids. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance criteria through a study with specific acceptance criteria as would be typical for a device with a more complex functional output (e.g., an AI-powered diagnostic tool).

Therefore, many of the requested categories in your prompt are not applicable to this type of device and submission. This is a basic medical device (a sponge) where "performance" is primarily assessed through physical and biocompatibility testing against established standards and comparison to similar predicate devices.

Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this specific submission:

1. A table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: Not explicitly stated. The document refers to "testing" performed for biocompatibility and physical properties, but does not provide details on the number of sponges tested.
• Data Provenance: Not specified. Testing would typically be conducted in a laboratory setting. No country of origin for "data" is relevant in the context of a physical product's performance testing.
• Retrospective or Prospective: N/A. This is for product testing, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. This device does not involve subjective interpretation or ground truth establishment by medical experts in the way a diagnostic device would. Performance is measured objectively through standardized tests.

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

• N/A. Adjudication methods are relevant for subjective assessments (e.g., expert reads) which are not part of this device's performance evaluation.

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

• N/A. This is a non-AI, non-diagnostic physical product. MRMC studies are not applicable.

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

• N/A. This is a non-AI physical product.

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

• The "ground truth" for this device's performance is objective measurement against established physical and chemical standards and comparison to a legally marketed predicate device's characteristics. No clinical outcomes data or expert consensus on features is mentioned or needed for this type of device.

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI/machine learning device.

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

• N/A. Not an AI/machine learning device.

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