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The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.

The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar. The device system consists of a Gas Regulator, Foot pedal, Tubing set, Adapter Handle, and FlexiTip XL-R rigid applicator. The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator.

The provided document describes the MEDAFOR DIRECT Gas-Assisted Application System, a medical device designed to assist in the delivery of powdered hemostatic agents during surgical procedures, including endoscopic surgeries.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in a quantified manner. Instead, it lists "Critical Parameters" for mechanical and functionality tests and broadly states, "All tests met acceptance criteria." This indicates that the device successfully passed all established thresholds for these parameters, although the specific thresholds are not provided.

Here's a summary of the critical parameters and the reported performance:

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

The document does not explicitly state the sample sizes for the mechanical and performance tests. For the "System Verification Test in Swine," it implies that animal testing was performed, but neither the number of animals nor the specific provenance (e.g., country of origin) or type (retrospective/prospective) of this data is mentioned.

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

The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily mechanical and functional, suggesting objective measurements against predefined engineering specifications rather than subjective expert assessment. The "System Verification Test in Swine" would likely involve veterinary professionals or surgeons, but their role in establishing "ground truth" and their qualifications are not detailed.

4. Adjudication Method for the Test Set

Since the tests appear to be objective mechanical and functional assessments, an adjudication method (like 2+1 or 3+1 used for expert consensus) is not applicable or mentioned. The results would likely be determined by direct measurement against established engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. The document focuses on demonstrating the device's basic functionality and safety through mechanical and animal testing, and its substantial equivalence to a predicate device, rather than comparing its effectiveness with and without AI assistance for human readers (as the device is not an AI-assisted diagnostic tool).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was done. This device is a mechanical system for delivering a substance, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the mechanical and performance tests, the "ground truth" was likely established through:

• Engineering Specifications/Standards: The device's design and performance were measured against predetermined specifications for compatibility, delivery, control, leakage, pressure, and flow.
• Intended Functionality: The "System Verification Test in Swine" aimed to confirm that the device "performs as intended under simulated conditions," implying a ground truth based on the expected outcome of delivering the powdered hemostat.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data in the context of establishing the device's functional integrity.

8. Sample Size for the Training Set

This information is not applicable. The device is a mechanical system, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This information is not applicable. As there is no training set mentioned for an algorithm, there is no ground truth establishment for such a set.

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HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological,) minor cuts, and lacerations and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.

HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

HemaDerm™ containing MPH (Microporous Polysaccharide Hemospheres™ ) is manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

This document is a 510(k) Premarket Notification from Medafor, Inc. for their device, HemaDerm™. It details the device's intended use and demonstrates its substantial equivalence to predicate devices, but it does NOT contain an acceptance criteria table or the results of a study designed to prove the device meets said criteria.

Therefore, the requested information cannot be extracted from the provided text.

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HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations.

HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Medafor. Inc.'s HemaDerm™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.

The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

This document describes the HemaDerm™ containing Hemadex™ Clotting Beads, a device intended for use as a topical dressing for the temporary treatment of severely bleeding wounds and for the local management and control of bleeding from percutaneous access sites.

Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in numerical thresholds for performance metrics. Instead, it relies on demonstrating equivalence to predicate devices and showing effectiveness and safety through various studies. The reported performance is qualitative and framed around achieving "accelerated rate of bleeding control" and "effectively control bleeding."

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

• Human Clinical Investigation: The document mentions "A non-significant risk clinical investigation using human subjects."
  • Sample Size: The exact sample size for the human clinical investigation is not specified.
  • Data Provenance: The document does not explicitly state the country of origin, but given the 510(k) submission to the FDA, it is highly likely to be prospective data collected within the United States.
• Animal Studies: "Animal testing using various animal models."
  • Sample Size: The exact sample size for the animal studies is not specified.
  • Data Provenance: Not specified, but generally, animal studies for FDA submissions are conducted under controlled conditions, likely prospective.

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

• Human Clinical Investigation: The study involved a "side by side comparison of HemaDerm™ and a control of normal clotting." The ground truth for bleeding control would likely be established by the healthcare professionals directly observing and managing the wounds.
  • Number of Experts: Not specified.
  • Qualifications of Experts: Implied to be "health care professional[s]" as the product is intended for use under their care. No specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set:

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "side by side comparison" in the human clinical investigation suggests direct observation and assessment by the healthcare professionals involved in the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No, an MRMC comparative effectiveness study was not explicitly described. The human clinical investigation mentioned was a "side by side comparison... and a control of normal clotting," which is a comparative study, but not specifically an MRMC study with multiple readers assessing performance against AI assistance.
• Effect Size: Not applicable, as an MRMC study with AI assistance was not mentioned.

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

• Not applicable. HemaDerm™ is a medical device (clotting beads), not an AI algorithm. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used:

• Human Clinical Investigation: The ground truth for efficacy appears to be based on clinical observation and assessment by healthcare professionals (e.g., direct observation of bleeding cessation, time to hemostasis, comparison to normal clotting). This could be categorized as expert clinical assessment and observation.
• Animal Studies: The ground truth for efficacy in animal models would be based on direct observation of bleeding control and potentially other physiological markers within the animal models.
• Biocompatibility: Ground truth established against ISO 10993-1 and FDA G95-1 standards (biological compatibility criteria).
• Sterilization: Ground truth established against AAMI / ANSI / ISO 11137 and EN552 standards for sterility assurance level.

8. The Sample Size for the Training Set:

• Not applicable. HemaDerm™ 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. As above, HemaDerm™ is a physical medical device.

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Over the Counter, OTC:

Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions.

Prescription, Rx:

Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.

Medafor, Inc.'s Bleed-X™ and Traumadex™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.

The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

The given text describes Medafor, Inc.'s Bleed-X™ and Traumadex™ containing Hemadex™ Clotting Beads. Here's an analysis of the acceptance criteria and the studies performed, based only on the provided information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it refers to the efficacy demonstrated through various studies and concludes that the device is "safe and effective for the control of bleeding wounds and perform in a manner equivalent and similar to the predicates." The reported performance is summarized qualitatively.

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

• Test Set Description: A "non-significant risk clinical investigation using human subjects" was conducted.
• Sample Size: The exact sample size for the human clinical investigation is not specified in the provided text.
• Data Provenance: The study used "human subjects," implying prospective human clinical data. The country of origin is not specified.

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

The document does not provide any information regarding experts used to establish ground truth or their qualifications for the human clinical investigation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The human clinical investigation involved a "side by side comparison of Bleed-X™ / Traumadex™ and a control of normal clotting," but it doesn't describe an MRMC design or the effect size of human readers with/without AI assistance (which is not relevant for this device).

6. If a Standalone (Algorithm Only) Performance Study was done

This device is a topical dressing, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable or described.

7. The Type of Ground Truth Used

For the human clinical investigation, the ground truth was likely based on observation of bleeding control and rate of clotting in a "side by side comparison" against "normal clotting." The document states it demonstrated "an accelerated rate of bleeding control."

8. The Sample Size for the Training Set

The document does not mention a training set as this is not an AI/ML device.

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

The document does not mention a training set or how its ground truth would be established, as this is not an AI/ML device.

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