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Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding.

Over-The-Counter Use: Zeolite Hemostatic Cotton is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.

The provided document, K223495, is a 510(k) Premarket Notification for the Zeolite Hemostatic Cotton. It details non-clinical tests conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device (K211570, Zeolite Hemostatic Gauze).

It's important to note that this submission does not include clinical study data (as explicitly stated in Section 6: "No clinical study is included in this submission."). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to non-clinical performance testing and biocompatibility assessments, not to AI-driven diagnostic or assistive technologies, nor to comparative effectiveness studies involving human readers and AI. The device described is a medical device for managing bleeding, not an AI software/device.

Given this context, I will address your points where applicable based on the provided document, acknowledging that many of your questions are geared towards AI/software medical devices or clinical trials, which are not present here.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The acceptance criteria and reported performance are based on physical performance testing, sterile barrier packaging testing, sterilization and shelf-life testing, and biocompatibility testing.

Here's a table summarizing the acceptance criteria and reported performance specifically from the "Non-Clinical Test Conclusion" section (Section 5) of the document:

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical)

Responses to Specific Questions (based on the provided document):

1. A table of acceptance criteria and the reported device performance:
   (See Table 1 above)

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

   • Sample Size: The document mentions "Three discrete batches of subject device were tested for water absorption, Zeolite content, and heat release." For other tests (e.g., packaging integrity, biocompatibility), the sample sizes are not explicitly stated within the public summary, but it's implied that sufficient samples were tested to meet the requirements of the listed ISO and ASTM standards.
   • Data Provenance: The tests were non-clinical, likely performed in laboratories affiliated with the manufacturer or their testing partners. The manufacturer is Hangzhou Zeo-Innov Life Technology Co., Ltd. in China. The data would be prospective, as these are tests performed on newly manufactured devices for regulatory submission.

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 question is not applicable. The "ground truth" here is defined by meeting predefined engineering, material science, and biological safety standards (e.g., specific thresholds for absorption, temperature, endotoxins, or qualitative assessments like "no cytotoxicity"). These are determined by lab analyses and standard protocols, not by expert consensus on clinical interpretation. There are no human "experts" establishing "ground truth" in the sense of clinical diagnoses in this context.

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies where human readers interpret data, often with conflicting interpretations requiring a tie-breaker. This document focuses on non-clinical laboratory testing where results are quantitative or qualitative against established thresholds, not subjective interpretations requiring adjudication.

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 is not applicable. The document explicitly states: "No clinical study is included in this submission." This device is not an AI-assisted diagnostic tool, and no MRMC study was performed or required for its 510(k) clearance based on substantial equivalence to a predicate hemostatic device.

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

   • This is not applicable. This device is a physical medical product (hemostatic cotton), not an algorithm or software. Therefore, there is no "standalone performance" of an algorithm.

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

   • For the non-clinical tests, the "ground truth" is based on pre-defined quantitative and qualitative performance specifications outlined in recognized international and national standards (e.g., ASTM, ISO, USP). For example, water absorption must be ≥10g, or certain biocompatibility tests must show "no cytotoxicity." This is a technical ground truth based on scientific and engineering principles rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

   • This is not applicable. This device is a physical product, not an AI/ML model that requires a training set.

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

   • This is not applicable as there is no training set for a physical medical device.

In summary: The provided FDA 510(k) summary for the Zeolite Hemostatic Cotton focuses entirely on non-clinical testing (physical properties, packaging, sterilization, biocompatibility) to demonstrate substantial equivalence. It explicitly states that no clinical studies were performed. Therefore, questions pertaining to AI/ML, human reader studies, clinical ground truth establishment, or training sets are not relevant to this document. The "acceptance criteria" discussed are for the device's physical and biological performance as per established standards for medical devices of this type.

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Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.

This FDA 510(k) summary provides information for a medical device called "Zeolite Hemostatic Gauze" (K211570). The document asserts substantial equivalence to a predicate device, QuikClot® eXTM (K072474), and references another device, QuikClot (K013390).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from various standards and internal specifications, as indicated by the non-clinical test conclusions. The reported device performance is presented as meeting these requirements.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Size used for the test set and the data provenance:

   • Physical performance testing: "Three discrete batches of subject device were tested." No further details on the number of units per batch or the provenance (country, retrospective/prospective) are provided beyond the manufacturer being in China.
   • Sterile barrier packaging testing: No specific sample size is provided beyond stating "sterile barrier packaging testing were performed." Provenance is assumed to be from the manufacturer in China.
   • Sterilization and shelf life testing: No specific sample size is provided for these tests, except for "aging samples" for shelf life. Provenance is assumed to be from the manufacturer in China.
   • Biocompatibility testing: No specific sample sizes for in vitro tests (cytotoxicity, sensitization, irritation, systemic toxicity) are provided. Provenance is assumed to be from the manufacturer in China.
   • Animal Study: 16 animals were selected for hemostatic testing: 8 for the subject device and 8 for the predicate device. The model used was a pig. Provenance is not specified beyond the manufacturer being in China, implying the study was conducted there. The study is prospective in nature as it involves active testing.

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

   • For physical performance, sterile barrier packaging, sterilization, shelf life, and biocompatibility, the acceptance criteria are based on established international and national standards (e.g., ASTM, ISO, USP, DIN). The "ground truth" here is the adherence to these standard specifications demonstrated through validated test methods, rather than expert interpretation of data. No external experts are mentioned for establishing ground truth for these tests.
   • For the animal study, the "ground truth" for hemostatic effectiveness is the measured outcome in the pig model. The document does not specify if external experts were used to establish the ground truth (e.g., blinded assessment of bleeding time/volume) or the qualifications of those who evaluated the results.

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

   • No adjudication method is mentioned for any of the non-clinical tests or the animal study. Test results are reported directly against the specified standards or internal criteria.

4. 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:

   • No MRMC or human reader study was mentioned. This device is a passive hemostatic gauze, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

   • This is not applicable as the device is a physical hemostatic gauze, not an algorithm. Performance testing (physical, biocompatibility, sterilization, and animal study) represents the "standalone" performance of the physical device.

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

   • Physical Performance, Sterile Barrier, Sterilization, Shelf-life: Ground truth is defined by published industry standards and specifications (e.g., ASTM, ISO, USP, DIN) and the results obtained from validated testing methods.
   • Biocompatibility: Ground truth is established by the results of tests conducted according to ISO 10993 series and USP standards, indicating the absence of adverse biological responses.
   • Animal Study: The ground truth for hemostatic efficacy is derived from direct observation and measurement of bleeding control in a live animal model (pig). This is a form of outcomes data within the controlled environment of an animal study.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through conventional non-clinical and pre-clinical testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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