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XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from, immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space, tissues above the inguinal ligament; or tissues above the clavicle.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament, or tissues above the clavicle.

The XSTAT 30 device consists of an applicator that facilitates delivery of minisponges to external bleeding wounds. The applicator with a telescoping handle is filled with ~ 92 minisponges and packaged in a vacuum-sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The XSTAT 30 3-pack consists of three (3) applicators in an individually sealed foil pouch and terminally sterilized by gamma radiation. The Instructions for Use ("FU") are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging. The XSTAT 30 1-pack consists of one (1) applicator in an individually sealed foil pouch and terminally sterilized by gamma irradiation. The Instructions for Use (IFU) are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging.

The XSTAT 12 device consists of an applicator and plunger that facilitate delivery of minisponges to external bleeding wounds. Individual applicators are filled with minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, and terminally sterilized by gamma radiation to a sterility assurance level of 10 °. The XSTAT 12 device consists of vacuum-sealed, gamma radiated, inner pouches which are packaged inside a larger outer pouch as a three (3) pack or one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.

The XSTAT devices comprise standard, regenerated cellulose medical sponge that is compressed and formed into minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. Each minisponge contains a radiopaque marker for easy detection via X-ray.

This document is a 510(k) summary for medical devices (XSTAT 30 and XSTAT 12), primarily focusing on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for an AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not present in this document.

However, I can extract the information relevant to the device's performance and the studies conducted to support its safety and effectiveness, interpreting them in the context of device approval rather than AI/ML model validation.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics for the XSTAT devices in the way one would for an AI/ML algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. This means the new devices (XSTAT 30 and XSTAT 12) must be shown to be as safe and effective as previously cleared devices.

The reported "performance" is qualitative, asserting that based on the conducted studies, the devices meet the bar for substantial equivalence.

Qualitative Performance Claims based on Studies:

• Hemostatic Efficacy: Demonstrated effectiveness in controlling severe, life-threatening bleeding.
• Radiopacity: Minisponges contain a radiopaque marker for easy detection via X-ray (a critical safety feature).
• Expansion Properties: Minisponges absorb blood and expand rapidly (within ~20 seconds) to fill the wound.
• Sterility: Terminally sterilized by gamma radiation to a sterility assurance level of 10⁻⁶.
• Biocompatibility: Demonstrated per ISO 10993.
• Mechanical Integrity (Applicator): Shown to be identical to predicate devices and thus assumed to perform similarly.
• Safety/Effectiveness: Overall claim that the devices are "as safe and effective" as predicate devices.

Summary of Studies and Data Provenance:

The document describes the following types of studies:

1. Bench Testing:

   • Applicator: Mechanical testing was not repeated because the applicators are identical to the predicate devices (K152624 for XSTAT 30, K161020 for XSTAT 12).
   • Minisponges: Performed to verify properties like:
     • Radiopacity and Radiopaque Marker Durability
     • Immunogenicity
     • Absorption Capacity
     • Extent of Swelling
     • Expansion Force/Pressure
   • Data Provenance: Not explicitly stated, but typically these are internal lab tests conducted by the manufacturer.

2. Biocompatibility Testing:

   • Conducted: Per ISO 10993 for the minisponges. Applicator biocompatibility was also demonstrated via predicate device clearance.
   • Data Provenance: Not explicitly stated, but likely conducted by the manufacturer or a contract research organization.

3. Animal Study:

   • Type of Study: GLP (Good Laboratory Practice) animal studies.
   • Purpose: To demonstrate safety and effectiveness, specifically for the hemostatic function.
   • Applicability: The animal testing of the minisponges using the XSTAT 30 applicator was considered "fully applicable" to the XSTAT 12 device because they use the same minisponges.
   • Data Provenance: Not explicitly stated, but usually conducted in a controlled laboratory setting (e.g., animal research facility).

This document is a regulatory submission for a medical device (hemostatic sponges), not an AI/ML algorithm. Therefore, the following sections are not applicable to the provided text.

2. Sample Size used for the test set and the data provenance: Not applicable. The studies are described in terms of "bench tests," "biocompatibility testing," and an "animal study," not AI/ML test sets. There are no explicit sample sizes provided for these tests, other than the general statement that they were conducted. Data provenance is implied to be from the manufacturer's internal testing or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of human experts establishing ground truth for a test set, as this is not an AI/ML study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is mentioned, as this is not an AI/ML study.

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/ML device; therefore, no MRMC study or assessment of human reader improvement with AI assistance 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.): The "ground truth" for this device's performance is established through direct physical and biological testing:

   • Bench Testing: Engineering specifications, material science properties, physical measurements (e.g., expansion time, absorption).
   • Biocompatibility Testing: ISO standards for biological safety.
   • Animal Study: Direct observation of hemostatic efficacy in a live animal model (a form of "outcomes data" in a pre-clinical setting).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

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Intended Use:
The XSTAT-12 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

Indications for Use:
XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT-12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT-12 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inquinal ligament; or tissues above the clavicle.

The XSTAT-12 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 38 minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. The minisponges expand only in length, not radially. Each minisponge absorbs approximately 3 mL of blood. Each minisponge contains a radiopaque marker for easy detection via X-ray. The XSTAT-12 dressing includes an applicator and plunger that facilitate delivery of the minisponges to external bleeding wounds. Individual applicators are filled with the STAT-12 minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, terminally sterilized by gamma radiation to a sterility assurance level of 10°. The inner pouches are then packaged inside a larger outer pouch, along with one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.

For the treatment of severe. life-threatening bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT-12 sponges are applied to the applicator. Once applied to the wound, the XSTAT-12 sponges absorb blood and expand, thereby packing the wound. All minisponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the minisponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every minisponge has been removed.

The acceptance criteria and study proving the device meets them are summarized below.

1. Table of Acceptance Criteria & Reported Device Performance:

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

The document does not explicitly state the sample sizes for the "test set" for the XSTAT-12 device. Instead, it relies heavily on equivalence to a previously cleared predicate device (XSTAT 30, K152624, and reference device DEN130016/K130218).

• Mechanical Testing: Performed on the XSTAT-12 applicator in expected use scenarios and extreme temperature conditions. No specific sample counts for each test are provided.
• Biocompatibility Testing: The battery of tests for the XSTAT-12 applicator included Cytotoxicity, Sensitization, Irritation, System Toxicity, and Hemocompatibility. Specific sample sizes for these tests are not provided.
• Minisponges & Animal Study: The XSTAT-12 minisponges are stated to be identical to the predicate device. Therefore, the testing and data provenance for these aspects are implicitly derived from the predicate's clearance. The original provenance for the predicate data is not detailed in this document.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The studies mentioned (mechanical, biocompatibility) appear to be conducted specifically for this device and its predicate.

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 studies primarily involve mechanical and biological testing, rather than human expert interpretation of medical images or conditions for establishing ground truth.

4. Adjudication Method:

This information is not provided. As the studies are primarily about device performance in mechanical and biological contexts, an adjudication method for human interpretation is not applicable here.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through engineering, mechanical, and biological performance data. There is no mention of human readers, AI assistance, or comparative effectiveness with or without AI.

6. Standalone (Algorithm Only) Performance:

Not applicable. The XSTAT-12 is a physical medical device (hemostatic sponges and applicator), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through:

• Mechanical performance standards: Demonstrating the applicator functions as intended under various conditions.
• Biocompatibility standards: Proving the materials are safe for biological contact.
• Material properties: Verifying the minisponges (identical to predicate) meet specifications for radiopacity, absorption, expansion, etc.
• Animal study results: (from predicate) demonstrating hemostatic efficacy.

This is primarily empirical evidence against pre-defined physical and biological criteria, rather than expert consensus, pathology, or outcomes data in the typical sense of AI/imaging studies.

8. Sample Size for the Training Set:

Not applicable. This device is hardware (sponges and applicator), not an AI algorithm that requires a training set.

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

Not applicable. As the device is not an AI algorithm, there is no training set or ground truth in that context.

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