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The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.

The D-Stat Radial has been sterilized with irradiation.

The provided text is a 510(k) Pre-market Notification for the D-Stat Radial Topical Hemostat. It focuses on demonstrating substantial equivalence to a predicate device, not on validating the device's absolute efficacy via a clinical study with detailed acceptance criteria and outcome measurements. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can provide what is present regarding the device's technical validation and comparison to a predicate.

The primary change in the device is to the retention strap material. The demonstration of substantial equivalence relies on:

• Performance Testing: "Securement Force"
• Biocompatibility Testing: "Cytotoxicity", "Sensitization", "Irritation"

Here's an analysis of what can be inferred or explicitly stated from the document:

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: The document only states "Device samples" were used for performance and biocompatibility tests. No specific sample sizes are mentioned.
• Data Provenance: Not specified, but generally, 510(k) testing is performed by the manufacturer or a contract research organization. The manufacturing facility is listed in Minneapolis, MN, USA.
• Retrospective/Prospective: Not applicable in this context as these are laboratory and bench tests, not clinical studies on patient cohorts.

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

• Not Applicable. The validation methods described (Securement Force, Biocompatibility) are objective laboratory tests against established standards (e.g., ISO 10993-1), not subjective assessments requiring expert consensus for "ground truth".

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

• Not Applicable. As mentioned above, the tests are objective, not 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

• No. This is not an AI/software device. The document describes a physical medical device (a hemostatic band).

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

• No. This is not an AI/software device.

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

• Ground truth for the performance and biocompatibility tests are the established specifications and ISO standards. For example, for biocompatibility, the ground truth is compliance with the limits set by ISO 10993-1. For securement force, the ground truth would be a predetermined force range or threshold.

8. The sample size for the training set

• Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

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

• Not Applicable. There is no training set for this device.

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The D-Stat Dry Silver and D-Stat Dry Clear Silver are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Silver and D-Stat Dry Clear Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Wrap Silver hemostatic bandage and Thrombix Silver Hemostasis Patch are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. D-Stat Dry Wrap Silver and Thrombix Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver and Thrombix Silver products are non-woven gauze pads lyophilized (frecze-dried) with procoagulant (thrombin, calcium chloride and sodium carboxymethylcellulose) and antimicrobial (ionic silver water) components. The D-Stat Drv/Wrap/ Thrombix pad creates a physical barrier to blood flow and facilitates hemostasis by the physiological coagulation-inducing properties of the lyophilized pad combined with compression. The lyophilized components (including thrombin) facilitate hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin. These products contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad and have not been clinically tested for their ability to reduce local infection, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI .

In the presence of fluids (i.e., blood and wound fluids), ionic silver is released from the silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. Ionic silver, an atom of silver that is missing one electron, provides the antimicrobial property by altering the protein structure and preventing bacterial cells from carrying out normal functions. The D-Stat Silver products demonstrated an antimicrobial effect in AATCC Test Method 100-2004 and Zone of Inhibition laboratory testing.

An adhesive foam or clear bandage accompanies some products in the family. All products are sterilized by electron-beam irradiation and are intended for single use only.

The provided text is a 510(k) summary for the D-Stat Dry Silver product family. It describes the device, its intended use, and provides a summary of studies performed to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not provide specific acceptance criteria or detailed study results in a format that allows for the creation of a table comparing acceptance criteria to reported device performance. It also lacks specific details on sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth as requested in the prompt. While it mentions some studies, it does not present them as standalone performance studies or MRMC comparative effectiveness studies.

Based on the information available in the provided text, here is a breakdown addressing the prompt's requirements, with explicit notes where information is not present:

Acceptance Criteria and Device Performance Study

The document states that "The subject device met all established specifications in the design verification bench testing" and "Statistical evaluation of data from an acute topical laceration study in a porcine model showed the time-to-hemostasis for the D-Stat Dry Silver did not exceed the time-to-hemostasis for the D-Stat Dry (no silver)." This indicates that the primary performance criterion for hemostasis was non-inferiority to the predicate device. For antimicrobial properties, the criterion was a "greater than a 4 log reduction in microbial population" and "comparable zones" to silver-containing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Hemostasis Study): Not explicitly stated, only mentioned as "an acute topical laceration study in a porcine model."
• Sample Size (Antimicrobial Testing): Not explicitly stated for the number of samples or replicates.
• Data Provenance: The hemostasis study was conducted in a "porcine model," indicating an animal study. Other tests (bench, in vitro) are laboratory-based. No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though the nature of these tests suggests they were prospective studies conducted for regulatory submission.

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

• Not Applicable: The studies described (animal model, lab tests) do not involve human experts establishing ground truth in the way a diagnostic AI device would. The "ground truth" for these tests is based on objective laboratory measurements and observation in the animal model.

4. Adjudication method for the test set:

• Not Applicable: Given the nature of the tests (animal model observation for hemostasis, quantitative lab tests for antimicrobial activity and physical properties), independent expert adjudication as defined for imaging or diagnostic studies is not relevant or described.

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: No MRMC comparative effectiveness study was conducted or described. This device is a topical hemostat, not a diagnostic AI device requiring human interpretation of data.

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

• Partially Applicable (but not an algorithm): The device itself performs its function (hemostasis, antimicrobial action) as a standalone product. The "studies" were essentially standalone performance evaluations of the device's physical and biological properties. However, this is not an "algorithm-only" performance in the context of AI.

7. The type of ground truth used:

• Hemostasis Study: The "ground truth" was the observed time-to-hemostasis in the porcine model.
• Antimicrobial Testing: The "ground truth" was quantitative measurement of microbial population reduction and zone of inhibition size using standardized lab methods (AATCC Test Method 100-2004).
• Biocompatibility: Based on objective ISO 10993 testing endpoints (cytotoxicity, sensitization, irritation).
• Other Bench Tests: Based on objective measurements against established engineering and material specifications.

8. The sample size for the training set:

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The product development process involves design and testing, but not machine learning training.

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

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The D-Stat Rad-Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat Rad-Band consists of a gauze pad secured to a release tab and retainer pad on a polycarbonate retainer at the end of an adjustable copolymer retention strap. Two foam pads included on the strap can be adjusted (or removed) for patient comfort. The D-Stat Rad-Band has a lyophilized non-woven gauze pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride to facilitate hemostasis. By pulling the release tab between the gauze pad and the retainer after hemostasis is achieved, the retention strap/retainer can be removed from the patient, leaving the gauze pad behind on the access site. The D-Stat Rad-Band includes an adhesive bandage.

The provided FDA 510(k) K092612 describes a medical device called the "D-Stat® Rad-Band," which is a topical hemostat. The document is an FDA clearance letter and a 510(k) summary, not a study report. Therefore, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific study to prove the device meets those criteria.

Based on the provided text, the document states:

"Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions."

This statement confirms that testing was conducted to address any differences from the predicate device. However, it does not provide specific details about:

• The exact acceptance criteria that were used.
• The reported device performance in relation to those criteria.
• The sample size of any test sets.
• The data provenance.
• The number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case studies.
• Standalone algorithmic performance.
• The type of ground truth used.
• The sample size or ground truth establishment for a training set.

Therefore, I cannot provide the requested information in a table or detailed descriptions directly from the given text. The document focuses on regulatory clearance based on substantial equivalence, which often means demonstrating that the new device performs as intended and is as safe and effective as a legally marketed predicate device, rather than providing the full details of performance studies against specific acceptance criteria in the format requested.

To obtain the detailed information about acceptance criteria and study results, one would typically need to refer to the full 510(k) submission, which is not fully included here, or additional study reports that would have been conducted by the manufacturer.

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The D-Stat® Dry Wrap hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines.

The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

I apologize, but the provided text from the FDA 510(k) notification for the D-Stat® Dry Wrap Hemostatic Bandage does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a Substantial Equivalence (SE) determination letter, which means the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This determination is primarily based on comparing the new device's indications for use and technological characteristics to those of existing, approved devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on this document.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." (Page 1)
• "The D-State Dry Wrap is substantially equivalent to the currently marketed Thrombix™ Patch Thrombin Hemostasis Patch and D-Stat® Dry Clear Hemostatic Bandage products based on a comparison of the indications for use and technological characteristics of the device." (Page 4, Conclusion 6)

This type of FDA letter does not typically include detailed performance study results or acceptance criteria that would be found in a full clinical trial report or a performance validation study.

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The D-Stat Dry Clear is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing a 4-6 Fr. introducer sheath.

The D-Stat® Dry Clear Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceutical license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The only difference between the D-Stat® Dry Clear Hemostatic Bandage and the predicate is the replacement of the opaque sterile bandage included with the device with a transparent sterile bandage.

The D-Stat® Dry Clear is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.

The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. This fundamental scientific technology is exactly the same as the predicate D-Stat Dry hemostatic bandage.

The provided document is a 510(k) Pre-market Notification for the D-Stat® Dry Clear Hemostatic Bandage. It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device. This type of document is generally for regulatory approval and does not contain specific acceptance criteria, device performance data, or detailed study results in the manner that would be expected for a comprehensive clinical study report.

Based on the content of the provided document, here's what can be extracted:

The document explicitly states: "No human clinical testing was required for this device." This means that a clinical study with a test set, ground truth, experts, or statistical analysis of device performance against acceptance criteria, as typically understood in a medical device efficacy study, was not performed for this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by highlighting commonalities.

Therefore, the requested information elements (1-9) cannot be fully populated as they pertain to a type of performance study that was not conducted for this 510(k) submission.

Here's an attempt to address the questions based on the available information, noting where information is explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "No human clinical testing was required for this device." Therefore, there were no specific acceptance criteria for a new clinical performance study, nor reported device performance from such a study. The submission relies on equivalence to a predicate device already on the market.

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

Not applicable. No human clinical testing was required, so there was no test set or associated data provenance.

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

Not applicable. No human clinical testing was required; therefore, no ground truth was established by experts for a test set.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. No human clinical testing was required; therefore, no adjudication method for a test set was employed.

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 hemostatic bandage, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a hemostatic bandage, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No human clinical testing was required to establish ground truth for a new device performance claim. The "ground truth" for the submission is the established safety and efficacy of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is not an algorithm that requires a training set.

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

Not applicable. The device is not an algorithm that requires a training set.

Summary of the 510(k) Submission's Approach:

The K073264 submission for the D-Stat® Dry Clear Hemostatic Bandage is a Special 510(k). As stated in the document, "No human clinical testing was required for this device." The basis for clearance is demonstrating substantial equivalence to an already legally marketed predicate device, the D-Stat® Dry Topical Hemostat (K030836).

The key argument for equivalence is:

• The only difference between the D-Stat® Dry Clear and the predicate is the replacement of an opaque sterile bandage with a transparent sterile bandage.
• All other core components and principles are the same: same lyophilized pad containing bovine-derived thrombin, CMC, and calcium chloride; same mechanism of action; same intended use/indications for use; same operating principle; same basic device design; same materials (for the active components); same shelf life; and same packaging and sterilization processes.
• A risk analysis (Failure Modes and Effects Criticality Analysis) was performed, and based on this assessment, "no design verification tests were required for inclusion of the sterile clear compression bandage to the D-Stat Dry Clear device."

Therefore, this submission relies on engineering and design control assessments to demonstrate that the minor change (transparent bandage) does not alter the fundamental safety or effectiveness established by the predicate device, obviating the need for new clinical trials.

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The Thrombix™ Patch is applied topically and is indicated as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The Thrombix " Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride.

The Thrombix" Patch is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.

The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

This document is a 510(k) summary for the Thrombix™ Patch, a thrombin hemostasis patch. It describes the device, its intended use, and comparative studies with predicate devices.

Here's an analysis based on your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for performance. Instead, it describes internal quality control tests and biocompatibility assessments. The "reported device performance" is essentially that the device was found suitable for its intended use based on these tests, and substantially equivalent to predicate devices.

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 primarily discusses bench testing for physical properties and biocompatibility.

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for internal quality control. No "test set" in the context of clinical data for performance assessment.
• Data Provenance: The tests are likely performed by Vascular Solutions, Inc. or their contracted labs. The country of origin of this internal testing data is not specified, but the company is based in Minneapolis, MN, USA. The data is retrospective in the sense that it was generated prior to submission for clearance.

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 document describes bench testing and biocompatibility assessments, not a study where expert ground truth was established for a test set.

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

Not applicable. This type of adjudication is relevant for studies involving human interpretation or clinical outcomes, which were not conducted for this submission (as stated in Section 6).

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 a medical device for hemostasis, not an AI-assisted diagnostic device. No MRMC study was conducted.

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

This question is geared towards AI/software as a medical device. The Thrombix™ Patch is a physical hemostatic device. The "standalone" performance refers to the device's intrinsic function as a hemostat, which was assessed through the non-clinical bench testing. No human-in-the-loop performance study was conducted or required.

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

For the non-clinical tests, the "ground truth" was established by standardized laboratory test methods and scientific principles for assessing physical properties (e.g., moisture content measurement, pH measurement, thrombin activity assay) and established biocompatibility testing protocols (e.g., MEM Elution, Intracutaneous Injection Test). There was no clinical ground truth (like pathology or outcomes data) used as no human clinical testing was required.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model. There is no "training set" for this device.

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

Not applicable. As there is no training set, there's no ground truth to establish for it.

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The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.

Each Thrombi-Paste Thrombin/gelatin powder paste hemostat includes the following components; A 10 mL syringe with attached mixing luer filled with 550mg of powdered absorbable gelatin sponge, USP (manufactured by Vascular Solutions, Inc. (VSI)), A vial of Bovine-derived Thrombin (5,000 IU, supplied to VSI by King Pharmaceuticals, U.S. license # 977), A diluent vial (5 mL, Supplied to VSI by Chesapeake Biological Laboratories, U.S. registration # 1123903), Mixing accessories (10 mL syringe and needleless, non-coring vial access device) and Applicator tips (1 - small bore tip, 1 - large bore tip). The pouch containing the syringe with gelatin powder also contains a desiccant packet to maintain low moisture levels.

The provided text is a 510(k) summary for the Thrombi-Paste® Thrombin/gelatin powder paste hemostat. It states that no human clinical testing was required for this device, which means there is no study that proves the device meets specific acceptance criteria based on human performance. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the performance of the device in comparison to its intended use (hemostasis). Instead, it lists non-clinical tests performed to confirm the suitability of the device, implying that the device met the internal criteria for these tests.

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

The document does not specify the sample sizes for each non-clinical test (e.g., how many syringes were tested for delivery force). The data provenance is internal, as "Vascular Solutions, Inc." manufactured the absorbable gelatin sponge and sourced other components. The tests are non-clinical (bench testing) and do not involve human data.

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

Not applicable. The "ground truth" for non-clinical bench testing is established by engineering specifications and objective measurements, not by human experts interpreting results in the way clinical studies require.

4. Adjudication method for the test set

Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to determine outcomes or classifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. The document explicitly states, "No human clinical testing was required for this device."

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

Not applicable. This device is a medical product (hemostat), not an algorithm or AI-based diagnostic tool. Performance is assessed through physical and chemical properties and basic functional tests, not by an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by the defined specifications and measurement standards for each physical and chemical property being tested (e.g., a specific pH value range is acceptable). This is based on scientific and engineering principles rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

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

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

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

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The ThrombiGe1® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds.and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The ThrombiGel® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride.

The ThrombiGel® thrombin/gelatin foam hemostat is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.

The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.

This document is a 510(k) premarket notification for the ThrombiGel® thrombin/gelatin foam hemostat. The information provided outlines non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics or presenting a study that proves it meets those criteria.

Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies and specific acceptance thresholds, which are not detailed in this submission for this type of device and regulatory pathway.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity for diagnostic devices, or specific clinical endpoints for therapeutic devices). It lists physical and biocompatibility tests whose results confirmed the suitability of the device for its intended use, but not explicit numerical targets.

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 for non-clinical tests.
• Data Provenance: The tests are described as "Bench testing" and "biocompatibility assessment," implying laboratory-based testing, not human-related data. No country of origin for the data is mentioned, but the submitter is Minneapolis, Minnesota, USA. The tests are non-clinical and would be considered prospective for the purposes of this submission.

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

Not applicable. Ground truth as typically understood for diagnostic/clinical studies (e.g., expert reads, pathology) is not relevant for the non-clinical physical and biocompatibility testing described.

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

Not applicable. Adjudication methods are for reconciling differing expert opinions in clinical studies, which were not performed 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. This is a medical device (hemostat), not an AI/diagnostic software. No MRMC study was performed.

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)

For the non-clinical tests, the "ground truth" would be established by the standardized protocols and acceptance criteria of the respective physical and biocompatibility tests themselves (e.g., ISO standards, pharmacopeial methods).

8. The sample size for the training set

Not applicable. This submission describes non-clinical testing for a medical device's substantial equivalence, not a machine learning model.

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

Not applicable. No training set for a machine learning model was involved.

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The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.

The D-Stat Dry Hemostatic Bandage consists of the following components:

• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
• Adhesive bandage
  The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The provided text describes the D-Stat Dry Hemostatic Bandage and its FDA 510(k) clearance, but it does not provide detailed acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

Here's a breakdown of why and what information is available:

Key Takeaways from the Document:

• Device: D-Stat Dry Hemostatic Bandage
• Intended Use: Applied topically as an adjunct to manual compression for control of surface bleeding from vascular access sites and percutaneous catheters/tubes, and reducing time-to-hemostasis in patients undergoing diagnostic endovascular procedures using 4-6 Fr. introducer sheaths.
• Regulatory Clearance: 510(k) substantial equivalence to predicate devices (D-Stat Dry Hemostatic Bandage K030836 and Syvek excel Vascular Access Hemostasis System K053300).
• Testing:
  • No non-clinical testing was conducted.
  • A "prospective, randomized, non-significant risk clinical investigation" was conducted. This study provided "clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures."
• Absence of Specific Performance Data: The document explicitly states "No performance standards have been developed under section 514 for this device" and does not present a table of acceptance criteria or reported device performance metrics (e.g., specific time-to-hemostasis in seconds, success rates). The clinical study is mentioned but no results are detailed.

Therefore, I cannot populate the requested table or answer questions 2-9 with the provided text. The document focuses on regulatory clearance via substantial equivalence rather than detailing performance studies against specific acceptance criteria.

Hypothetical Example of what the document would need to contain to answer your questions (this is NOT in the provided text):

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

2. Sample sized used for the test set and the data provenance
* Test Set Sample Size: [e.g., 200 patients (100 control, 100 device)]
* Data Provenance: Prospective, multi-center study conducted in the USA and Canada.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable for this type of device where objective measurements (time, re-bleeding) are typically used rather than subjective expert consensus on images/data. For a device like this, the "ground truth" is typically the directly measured clinical outcome.

4. Adjudication method for the test set
* Not applicable as the outcomes (e.g., time to hemostasis, re-bleeding) are objectively measured during the procedure and follow-up. An independent Clinical Events Committee (CEC) might adjudicate serious adverse events, but not the primary efficacy endpoint.

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 a medical device for direct application, 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 a physical medical device, not an algorithm.

7. The type of ground truth used
* Clinical outcomes directly measured: Time-to-hemostasis, presence/absence of re-bleeding, adverse event rates.

8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established
* Not applicable.

In summary, the provided document serves as an FDA clearance letter based on substantial equivalence and briefly mentions a clinical study, but it lacks the detailed performance data and study specifics needed to fully answer your request.

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The ThrombiGel thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percularedus and or tubes.

The ThrombiGel thrombin/gelatin foam hemostat consists of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. The ThrombiGel is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

This document is a 510(k) summary for the ThrombiGel™ thrombin/gelatin foam hemostat. It provides information about the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.

Therefore, I cannot provide the specific information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies directly from the provided text.

However, I can extract the information that is present:

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

This information is not present in the document. The document states: "Testing included assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use." This is a high-level summary and doesn't provide specific acceptance criteria or quantitative performance metrics.

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

This information is not present in the document. The "Summary of Non-Clinical Testing" mentions "assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use," but it does not specify sample sizes or data provenance. The testing appears to be non-clinical, likely bench testing.

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 present in the document.

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

This information is not present in the document.

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 present in the document. The device is a hemostat, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be applicable.

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

This information is not present in the document. The device is a physical product (thrombin/gelatin foam hemostat), not an algorithm or software. Standalone performance as an algorithm is not applicable.

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

This information is not explicitly stated in the document. For a hemostat, "ground truth" would likely involve standardized bleeding models (in vitro or in vivo animal studies) where the cessation of bleeding is objectively measured. The document only vaguely refers to "assessment of the physical properties... and its ability to achieve its intended use."

8. The sample size for the training set:

This information is not present in the document. The device is a physical medical device, not a machine learning model, so the concept of a "training set" in the context of AI is not applicable.

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

This information is not present in the document, as the concept of a "training set" and "ground truth" for a training set is not applicable to this type of device.

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