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Chito-SAM™ Active (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions.

Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.

The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. 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 Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.

Please note: The provided FDA 510(k) summary for the Chito-SAM™ Active device does not explicitly state acceptance criteria or direct device performance against those criteria in a table format. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, the response below will synthesize information regarding "acceptance criteria" from the described non-clinical tests and the "reported device performance" will be derived from the general statements of a successful outcome in these tests. Information that is not present in the provided document will be explicitly stated as "Not provided in the document."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not explicitly provided. The document mentions "non-clinical testing" which includes functional testing, biocompatibility testing (per ISO 10993-1), in-vivo hemostasis testing, and shelf-life testing. The specific number of samples or animals used for each test is not detailed.
• Data provenance:
  • Country of origin: Not explicitly stated for specific tests.
  • Retrospective or prospective: The non-clinical tests described (functional testing, biocompatibility, in-vivo hemostasis, shelf-life) are generally prospective studies designed to evaluate the device.

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

• Not applicable/Not provided. For non-clinical (bench and animal) testing, "ground truth" is typically established by objective measurements, laboratory analyses, and physiological observation, rather than expert consensus on subjective data. The document does not mention the involvement of experts for "ground truth" establishment in the context of these non-clinical tests.

4. Adjudication method for the test set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there is potential for disagreement in subjective assessments. The non-clinical tests described do not involve such a process.

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 hemostatic dressing, not an AI software/algorithm requiring human interpretation or assistance. Therefore, an MRMC study related to AI assistance for human readers was not performed or described.

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

• Not applicable. This device is a hemostatic dressing, not an AI algorithm. Its performance is evaluated through direct physical, chemical, and biological testing, not by an algorithm.

7. The type of ground truth used

• For non-clinical testing:
  • Functional Testing (Liquid Absorption, pH, Tensile Strength, Platelet Aggregation): Ground truth is based on established laboratory standards, specifications, and comparison against predicate devices' known performance.
  • Biocompatibility Testing (ISO 10993-1): Ground truth is determined by the specific criteria and endpoints defined in the ISO standard for cytotoxicity, irritation, sensitization, hemolysis, and systemic toxicity.
  • In-vivo Hemostasis Testing: Ground truth is established by physiological outcomes (e.g., control of bleeding, time to hemostasis) observed in the animal model, often compared to an untreated control or predicate device.
  • Shelf-life Testing: Ground truth is based on physical, chemical, and microbiological stability over time, validated through accelerated and real-time aging studies against predefined acceptance limits.

8. The sample size for the training set

• Not applicable. This is a medical device (hemostatic dressing), not an AI algorithm that requires a training set.

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

• Not applicable. As stated above, this is not an AI algorithm requiring a training set.

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The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

• . To control difficult bleeds in the inguinal area.
• . To control difficult bleeds in the axilla area.
• To immobilize a pelvic fracture. .

The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage and axilla hemorrhage. The device is designed to control bleeding in the inguinal area or axilla area where standard tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.
A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable Target Compression Device (TCD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.
The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state a specific "test set" or its sample size in the context of device performance. The testing mentioned is "Cadaver" and "Bench" testing, which implies laboratory or simulated environments rather than a traditional clinical test set with human patients. The data provenance is not further specified beyond these testing types.

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

This information is not provided in the document. The nature of "Cadaver" and "Bench" testing typically involves controlled measurements and evaluations by engineers or medical professionals involved in the product development, rather than a panel of external experts establishing ground truth in the way described for clinical studies.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of "Cadaver" and "Bench" testing, a formal adjudication method for a test set as seen in clinical trials is unlikely to have been implemented in the traditional sense.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical medical device (tourniquet), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.

7. Type of Ground Truth Used:

For the performance testing, the "ground truth" would be established through direct physical measurements and observations during the "Cadaver" and "Bench" tests, comparing the device's ability to achieve its stated functions (e.g., occlude arteries, immobilize a pelvic fracture) against predetermined technical specifications or physiological outcomes in the simulated environments. This is a form of technical or functional validation rather than expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and functionality are developed through engineering processes, material science, and iterative testing.

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

Not applicable, as there is no training set for a physical device. The "ground truth" for the device's design and development comes from engineering principles, relevant medical knowledge (e.g., anatomy, physiology of bleeding control and fracture immobilization), and results from iterative bench and cadaver testing during the product development cycle.

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The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

• To control difficult bleeds in the inguinal area. .
• To immobilize a pelvic fracture. .

The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage. The device is designed to control bleeding in the inguinal area where standard Tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.
A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable point pressure device (PPD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.
The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.

The SAM Junctional Tourniquet (SJT) is a medical device designed to control difficult bleeds in the inguinal area and immobilize pelvic fractures, particularly in battlefield and trauma situations. The FDA cleared its 510(k) submission (K123694) in 2013, determining it substantially equivalent to the Combat Ready Clamp (CRoC).

Here's an analysis of the acceptance criteria and the studies conducted to demonstrate this:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for the SAM Junctional Tourniquet (SJT) is based on substantial equivalence to a predicate device, the Combat Ready Clamp (CRoC). This means the focus of the acceptance criteria isn't on a predefined set of performance metrics that the SJT must achieve independently, but rather on demonstrating that the SJT is as safe and effective as the predicate device and that any differences do not introduce new safety or performance concerns.

Given the information provided, the acceptance criteria are implicitly linked to the attributes where the SJT is compared to the CRoC, particularly in terms of functionality and safety. The reported device performance is demonstrated through non-clinical testing.

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

• Sample Size for Test Set: The document explicitly mentions "Cadaver" and "Human Simulation Testing." However, it does not provide specific numerical sample sizes for either of these tests.
• Data Provenance: The document does not specify the country of origin for the cadaver or human simulation testing data. It is implied that these are prospective tests conducted specifically for the purpose of demonstrating the device's performance.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver or human simulation testing. Given the premarket notification context, such testing would likely involve trained medical professionals, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the testing described (cadaver and human simulation), it is more likely that performance was assessed based on observation and measurement rather than human reader 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. The provided information pertains to a physical medical device (a tourniquet), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

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

No. As stated above, this is a physical medical device, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing appears to be based on:

• Direct observation and measurement during cadaveric studies: To assess the device's ability to achieve arterial occlusion and pelvic immobilization.
• Performance metrics in human simulation: Likely involving simulated scenarios to evaluate ease of use, application technique, and effectiveness under specified conditions.
• Material specifications and standard testing: For biocompatibility (ISO 10993-1, USP Plastic Class VI) and PPD integrity (burst pressure, stability).

8. The Sample Size for the Training Set

Not applicable. The SAM Junctional Tourniquet is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. No training set was used.

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To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.

SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space.
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.

The provided text is a 510(k) summary for the SAM Chest Seal product family, which includes the SAM Chest Seal with Valve and the SAM Chest Seal. It describes the device, its intended use, and its comparison to predicate devices. It states that the device is substantially equivalent to the predicate devices.

However, the document does not contain information regarding a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert evaluations.

Here's a breakdown of why the requested information cannot be provided from this document:

1. Clinical Data: Section H explicitly states, "Clinical data are not included in this submission." This means no study was performed to demonstrate performance against specific acceptance criteria.
2. Performance Testing (Non-clinical): Section G states, "Performance testing demonstrated that the Chest Seal devices perform as well as, or better than, the predicate device." This refers to non-clinical data, likely bench testing or engineering evaluations, and does not provide specific metrics or acceptance criteria in the document.
3. Regulatory Nature: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study that proves the device meets them because the provided text indicates that no clinical data was included in this submission to establish such criteria or performance.

The document concludes that the devices are "substantially equivalent" to predicate devices based on non-clinical data, design, function, materials, and intended use. This is the primary "proof" used for 510(k) clearance in this case, not a clinical study with detailed performance metrics.

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