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TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.

The provided document is a 510(k) summary for the TRAUMAGEL® Hemostatic Gel. It primarily focuses on demonstrating substantial equivalence to a predicate device (CELOX Gauze Pro) based on design, technological characteristics, and non-clinical testing.

The document does not include the information requested regarding a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI/software performance. This is because TRAUMAGEL® is a medical device (hemostatic gel), not an AI or software-based medical device. Therefore, the questions about sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, AI assistance, training data, etc., are not applicable to this product and its regulatory submission.

The "Acceptance Criteria" described in the document relate to biocompatibility testing and performance bench testing for a physical medical device, not a software algorithm.

Here's a breakdown of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance (for biocompatibility testing):

(Note: "Physical and/or Chemical Information" acceptance criteria is listed as N/A, as it's for information gathering, not a Pass/Fail test.)

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: Not explicitly stated for each non-clinical test, but implied to be sufficient for the required ISO standards.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory and animal studies).

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

• Not applicable as this is not a diagnostic AI/software device requiring human expert annotation of images/data for ground truth. The "ground truth" for the non-clinical tests is established by the standardized test methods (e.g., ISO standards for biocompatibility) and direct measurement of physical or biological responses.

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

• Not applicable for non-clinical device testing.

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; this device is a physical hemostatic product, not an AI/software.

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

• Not applicable; this is not a software algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO standards and observed biological responses.
• For performance bench testing: Physical and chemical properties measured against predefined specifications.
• For non-clinical animal studies: Direct observation of hemostatic performance in a porcine model. The document states: "testing demonstrated substantially equivalent performance between the device and the predicate."

8. The sample size for the training set:

• Not applicable; there is no AI/machine learning training set for this product.

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

• Not applicable.

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Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.

The information provided pertains to the regulatory submission for a medical device (Polysaccharide Hemostatic Powder) and does not describe acceptance criteria for a study showing device performance in the way typically associated with AI/ML-based diagnostic devices. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through non-clinical testing.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable or not explicitly detailed in this type of submission.

However, I can extract the non-clinical testing performed and the conclusions drawn to fulfill the spirit of the request regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this regulatory document.

Here's a breakdown based on the provided text:

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

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

• Sample Size: Not specified in terms of numerical size for the animal model or other non-clinical tests. The document only mentions "a porcine animal model."
• Data Provenance: The animal study was performed (implied as part of the manufacturer's testing). No country of origin for the data is specified, nor is it classified as retrospective or prospective (animal studies are typically prospective).

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

• Not Applicable. This information is typically required for studies involving human clinicians interpreting data or images. The current submission describes non-clinical and animal testing.

4. Adjudication method for the test set

• Not Applicable. Again, this is relevant for studies involving human interpretation and disagreement resolution, which is not described here.

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. No MRMC study was conducted, as this device is a physical hemostatic powder, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used

• For the animal study ("safety and effectiveness study on a porcine animal model"), the "ground truth" would likely be derived from direct observation of hemostasis and potentially histological examination of the wound site, compared to the performance of the predicate device. For other non-clinical tests (sterilization, shelf-life, biocompatibility, design verification), the ground truth is established by meeting predefined scientific and regulatory standards (e.g., bioassay results meeting specified limits, physical tests meeting design specifications).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set.

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

• Not Applicable. This is not an AI/ML device requiring a training set.

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Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations

Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.

Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;

• Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
• Gauze(S) Type: There is strap yarn part on the Hemoblock_S

The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study; instead, it is a 510(k) premarket notification summary for a hemostatic dressing called "Hemoblock S". The document details the device's characteristics, its comparison to a predicate device, and non-clinical testing performed (biocompatibility, sterilization, shelf-life, and general performance tests like appearance, dimension, tensile strength, absorption, X-ray impermeableness, and in vitro blood clotting test). It also mentions an animal study for hemostatic testing.

There is no mention of a study involving a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific acceptance criteria with reported device performance in the context of diagnostic accuracy or AI assistance. The performance tests mentioned are related to the physical properties and sterilization of the dressing, not its diagnostic or assistive capabilities for human readers.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding acceptance criteria and study results for device performance in the context of the questions asked.

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RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyroqenic and derived from plant starch. The device contains no human or animal components.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called RESPONDER® Polysaccharide Hemostat. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC) typically found in clinical study reports.

The document primarily states that the new models (RP0002/RP0003/RP0005) of the RESPONDER® Polysaccharide Hemostat are substantially equivalent to a previously cleared device (K220525) for over-the-counter (OTC) indications. This substantial equivalence is based on the new models having the same raw material, production technique, packaging, sterilization, indications for use, composition, form of device, method of application, mechanism of action, biocompatibility, and resorption performance as the previously cleared predicate device.

Key takeaway for your request: The entire document points to "substantial equivalence" as the primary "acceptance criterion" rather than a specific numerical performance metric. The study proving this is essentially the demonstration that the new device models are identical in all relevant aspects to a previously cleared device.

Given the information available, I can provide what is implied by the document regarding your questions:

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):

This document does not specify a distinct "test set" or its sample size for evaluating the new device models. The "study" here is largely a comparison to a previously cleared device. The equivalence is stated based on common characteristics. There is no information about data provenance.

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):

Not applicable. The ground truth for this submission is based on the established safety and performance of the predicate device, not a new "test set" requiring expert ground truthing in the typical sense of a clinical or diagnostic study.

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

Not applicable. This is a regulatory clearance based on substantial equivalence, not a clinical trial with adjudicated outcomes from a test set.

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. The device is a hemostat (a physical product to stop bleeding), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the regulatory clearance and established safety/performance profile of the predicate device (RESPONDER® Polysaccharide Hemostat, K220525) based on previous submissions and evaluations.

8. The sample size for the training set:

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

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

Not applicable. See point 8.

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RESPONDER® Polysaccharide Hemostat Rx is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.

RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch. The device contains no human or animal components.

The provided text is a 510(k) summary for the RESPONDER® Polysaccharide Hemostat. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific, pre-defined acceptance criteria through a clinical or algorithmic performance study in the way one might for an AI/ML medical device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth.
• Details of MRMC or standalone performance studies, if done.
• Ground truth types (expert consensus, pathology, outcomes data).
• Sample size for training sets or how ground truth for training was established.

Instead, the document focuses on:

• Device Description: RESPONDER® Polysaccharide Hemostat is composed of absorbable modified polymer (AMP®) particles derived from plant starch.
• Intended Use/Indications for Use:
  • Rx: Temporary control of severe topical bleeding in emergency situations.
  • OTC: Local management of bleeding from minor lacerations, minor cuts, and minor abrasions.
• Predicate Device: CELOX Topical Hemostatic Granules (K061079).
• Technological Characteristics: Claims similar physical structure (granules), packaging (foil pouch), shelf life, and mechanism of action (forming a gel barrier) to the predicate.
• Performance (Demonstration of Equivalence, not specific acceptance criteria):
  • Biocompatibility: Tests (ISO10993-5, -6, -10, -11, ASTM F756-17, USP41 NF36) indicated it is biocompatible and safe.
  • Sterility: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶, despite a different sterilization method than the predicate.
  • Animal Studies: Conducted to validate efficacy and safety compared to the predicate, with results demonstrating the proposed device is "as safe as" the predicate device. Specific performance metrics from these animal studies are not detailed in this summary, nor are "acceptance criteria" for these metrics provided.

In summary, this document is not a clinical study report or an AI/ML device performance study. It's a 510(k) summary demonstrating substantial equivalence to a commercially available predicate device based on technological characteristics, biocompatibility, sterility, and general safety/efficacy in animal models, not on specific, quantitatively defined acceptance criteria for human performance or algorithmic output.

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Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip.

Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.

This document, a 510(k) Premarket Notification for the Celox Rapid X-Ray Gauze, describes the device and its claimed substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human reader performance study.

The provided document is for a hemostatic gauze, not an AI-powered medical device or software. Therefore, many of your questions, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this document. The "Performance Data" section in the document refers to in-vitro and in-vivo (animal) testing related to the physical and biological performance of the gauze itself, not the performance of an AI algorithm.

Based on the provided document, here's what can be extracted, acknowledging the limitations:

Acceptance Criteria and Device Performance (as covered by this document)

The document focuses on demonstrating that the new device, Celox Rapid X-Ray Gauze, is substantially equivalent to existing predicate devices, particularly the Celox Rapid Gauze (K110386), with the key difference being the addition of an X-ray detectable strip. The acceptance criteria, in this context, are primarily related to confirming that this modification does not negatively impact the device's hemostatic function and that it remains safe and effective for its intended use.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Hemostatic Gauze)

Given this is a physical medical device (hemostatic gauze), not an AI, the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or AUC. Instead, they are about functional performance and safety.

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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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The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.

The provided text describes the Axiostat Patch, a hemostatic dressing, and outlines the non-clinical studies performed to demonstrate its safety and performance for its intended use. However, it does not contain information related to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document details the following types of studies for a physical medical device (hemostatic patch):

• Biocompatibility testing: Performed according to ISO 10993-1:2009 for surface devices, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and bacterial endotoxin.
• Heavy metal testing: To ensure the finished, sterilized product met USP-232 limits.
• Bench performance testing: Including appearance, moisture content, absorbency, pH, integrity, tensile strength, and in vitro blood clotting.
• Barrier to bacteria testing: Evaluated the patch's ability to act as a barrier against gram-positive and gram-negative bacteria.
• Animal studies: Evaluated hemostasis in a vascular injury wound model in swine.
• Sterilization and packaging validation: Including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests to validate a 5-year shelf life.

Since the provided text does not describe an AI medical device or its performance criteria, I am unable to answer most of your specific questions related to AI device acceptance criteria, sample sizes for test/training sets, expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot populate the table or provide details for points 2-9 as the provided document does not contain this information for an AI device.

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The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

The proposed device, Hemostatic xerogel sponge, is available in three models for different size. The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.

The document describes non-clinical performance data for the Hemostatic Xerogel Sponge to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • For physical testing (water absorption, density), the document does not specify the exact number of samples tested, only referring to "samples" and "each sample."
  • For package integrity testing, the document does not specify the number of packages or tests performed.
  • For sterilization testing (EO/ECH residue, endotoxin), the document does not specify the number of devices tested.
  • For the animal study, the document does not explicitly state the number of animals used, only that "A new in vivo testing using swine femoral artery as a model is conducted."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is Solaplus Biotech Co., Ltd. located in Wenzhou, China, and the designated submission correspondent is Mid-Link Consulting Co., Ltd in Shanghai, China, it is reasonable to infer the studies were conducted in China, likely prospectively for the purpose of this 510(k) submission.

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

• This information is not provided in the document. The studies described are non-clinical engineering and animal studies, not human clinical trials or expert-adjudicated performance evaluations in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication for establishing ground truth.

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

• No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (hemostatic sponge), not an AI diagnostic or assistive technology for human readers.

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

• Not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

• For physical testing (water absorption, density): The ground truth is based on direct measurement against predefined quantitative physical property specifications.
• For package integrity testing: The ground truth is based on established engineering standards for package performance (e.g., seal strength, dye penetration).
• For sterilization testing: The ground truth is based on chemical residue limits (ISO 10993-7) and biological contamination limits (USP ).
• For the animal study: The ground truth for effectiveness is the direct observation of hemostasis in the swine femoral artery model, compared to the performance of the predicate device.

8. The sample size for the training set

• This information is not applicable. The document describes the performance of a physical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

• This information is not applicable for the same reason as above.

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OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved.

OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.

The provided document is a 510(k) summary for the OMNI-STAT Vascular Rapid device, asserting its substantial equivalence to a predicate device (CELOX Vascular). This type of submission focuses on demonstrating equivalence to an already legally marketed device rather than proving de novo safety and effectiveness through, for example, a clinical trial with specific acceptance criteria on performance metrics like sensitivity, specificity, and AUC, as one might see for an AI/ML medical device.

Therefore, the information typically found in acceptance criteria and study results for an AI/ML device (e.g., performance metrics, sample sizes for test/training sets, ground truth establishment with expert consensus, MRMC studies) is not present in this document because it is not relevant to a 510(k) submission for this type of device.

This document describes a physical hemostatic dressing, not an AI/ML device. The "performance data" section refers to bench testing (e.g., tack adhesion, absorbency, tensile strength, packaging integrity) and evaluations of biocompatibility and sterilization, all aimed at demonstrating the new device's similarity and acceptable performance compared to the predicate, especially given a minor modification (addition of a bio-adhesive).

To directly answer your request based on the provided document:

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

The document doesn't present "acceptance criteria" in the format of strict numerical thresholds for parameters like sensitivity or specificity because it's not an AI/ML device with such performance metrics. Instead, "acceptance criteria" are implied by the comparative testing against the predicate device and relevant standards.

• Absorbency: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Wet Tensile Strength and Elongation: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Dimension: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Packaging Integrity & Strength: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria." |
  | Biocompatibility | - ISO 10993-1 Compliance: No new testing was carried out on the subject device. Compliance was established based on "toxicology risk assessment and data from CELOX Vascular and CELOX Rapid Gauze" (predicate and reference devices). The rationale states the device "is deemed in compliance with the requirements of ISO 10993-1." |
  | Sterilization | - Validation: Assessed and evaluated in compliance with ISO 11137-1. Sterilization dose audits are carried out using VDmax25 as defined in ISO 11137-1. Achieves Sterility Assurance Level (SAL) of 10^-6, consistent with the predicate. |
  | Shelf-life | - Duration: 3 Years based on predicate stability data (Note: Predicate device has 5 Years, but the new device relies on predicate data for 3 years). |
  | Hemostasis Efficacy | - Porcine Bleeding Models: No new pre-clinical testing was deemed necessary for substantial equivalence for the modified device. Previous testing in porcine bleeding models was performed for both the predicate devices (CELOX Vascular and CELOX Rapid Gauze), and the results "demonstrate that they both support the claim with regards to the control of bleeding and hemostasis being achieved." The document implies that because the modified device is substantially equivalent in design and materials (with an improved adhesion profile), these existing efficacy data for the predicate are sufficient. |

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a single "test set" for a diagnostic performance evaluation. For bench testing (e.g., tack adhesion, absorbency), specific sample sizes are not provided in this summary but are usually defined per test protocol (e.g., n=3, 5, or 10 replicates).
• Data Provenance: Not specified regarding "country of origin." The testing was "carried out in line with Medtrade products Ltd Design Control process," implying it was conducted by or for the manufacturer (Medtrade Product Ltd, based in the UK). The data is retrospective in the sense that the testing for this device has been completed, and the results are being submitted.

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

This is not applicable. The device is a physical hemostatic dressing, and its performance (e.g., adhesion, absorbency) is measured by objective mechanical/material tests, not by expert interpretation of images or signals that would require a "ground truth" established by experts in an AI/ML context.

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

Not applicable, as there is no expert adjudication process for this type of 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:

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by standardized physical/chemical tests (e.g., ASTM, ISO standards for materials, sterility) and previously conducted pre-clinical studies (e.g., porcine bleeding models) for the predicate device, which established its hemostatic efficacy. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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