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XSTAT 30 Pouch is intended to be a hemostatic wound dressing.

XSTAT 30 Pouch 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 30 Pouch 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 Pouch is a temporary device for use up to six (6) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, 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 Pouch is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen: the retroperitoneal space: the sacral space: tissues above the inquinal ligament: or tissues above the clavicle.

The XSTAT 30 Pouch is comprised of the following components:

1. Minisponge Pouches (3 pouches per device)
2. Applicator/Plunger
3. Packaging and Labeling

The XSTAT 30 Pouch is a modified version of the company's legally marketed XSTAT 30 Gen2 device (K180051, "XSTAT 30 Gen2' or "predicate device"). The technological differences between the XSTAT 30 Pouch and the predicate device are:

• The enclosure of the minisponges in three (3) porous pouches to facilitate their removal from . wounds;
• Changing the shape of the minisponges from round to hexagonal; and
• Including a radiopaque marker in each pouch in lieu of marking each individual minisponge. .

The minisponge pouches are comprised of a tubular knit woven textile constructed with an ultra-high molecular weight polyethylene (UHMWE) fiber. The pouch has a tensile strength of > 200 lbs and is resistant to tearing with surgical tools such as forceps and standard shears. The XSTAT 30 Pouch contains three (3) separate minisponge pouches within each applicator. A medical-grade radiopaque filament (barium sulfate-infused polypropylene) is attached on the interior of each of the three pouches.

The minisponges are comprised of a compressed cellulose sponge. When compressed, each minisponge has a height of approximately 5 mm and a surface diameter of 9 mm. Upon contact with blood, the minisponges absorb blood and, if unencumbered, are capable of expanding to a precompressed height of 40-50 mm within approximately 20 seconds. The sponge expands only in length (not width).

The applicator and plunger facilitates delivery of minisponge pouches to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and expand to fill and pack the wound.

The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deploy the minisponge pouches from the applicator.

One (1) applicator is filled with three (3) minisponge pouches and packaged with one (1) plunger in a vacuum-sealed nylon/poly package and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The Instructions for Use (IFU) will be printed on or adhesively affixed to the package.

The provided document is a 510(k) Premarket Notification from the FDA for the XSTAT 30 Pouch. This document outlines the device's substantial equivalence to a predicate device, not the acceptance criteria and performance of a new AI/ML-driven medical device, which is typically what the requested questions target.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes for training/test sets, ground truth establishment, and expert involvement are not applicable to this document. The document describes a medical device (hemostatic wound dressing) and its comparison to a previously cleared predicate device, focusing on bench testing, biocompatibility, sterility, shelf-life, and an animal study. It does not mention any AI/ML components.

However, I can extract the information that is present and indicate where the requested information is not applicable.

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

The document does not explicitly state "acceptance criteria" in the traditional sense for an AI/ML device. Instead, it describes performance characteristics and testing conducted to demonstrate substantial equivalence to a predicate device. The performance is reported in terms of successful completion of tests or equivalence.

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set.
  • For the animal study, the document states "The company has conducted a GLP animal study." The specific number of animals is not provided.
  • For bench testing, biocompatibility, and sterility validation, sample sizes for individual tests are not detailed in this summary document but would be part of the full study reports.
• Data Provenance:
  • The animal study was a GLP (Good Laboratory Practice) study, which implies a controlled, prospective experimental design. The country of origin for the animal study or other testing is not specified.

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. This device is not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. The efficacy and safety were evaluated through bench, animal, and biocompatibility testing. The "ground truth" for these tests would be objective measurements and observations according to established protocols.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring an adjudication method for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/ML diagnostic tool and no "human readers" or AI assistance are part of its intended use or evaluation.

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

Not applicable. There is no algorithm or AI component mentioned for this device.

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

The "ground truth" for this device's evaluation was primarily based on:

• Objective measurements from bench testing (e.g., expansion rate, absorption capacity, durability, radiopacity, deployment force).
• Results from biocompatibility testing against ISO 10993 standards.
• Demonstration of sterility to a specified SAL (10⁻⁶).
• Physiological and clinical outcomes from a GLP animal study, comparing the new device's performance (e.g., hemostasis) to the predicate device in a femoral injury model.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable. This device does not involve an AI/ML "training set" or its ground truth establishment.

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XSTAT 30 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 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 for immediate life-threatening bleeding from, 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 retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds.

The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

This document is a 510(k) Summary for the XSTAT 30 device, a hemostatic device. The purpose of a 510(k) is to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This submission does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way this request is typically interpreted for AI/ML devices, or even for many traditional medical devices.

Instead, the document details a comparison of the new XSTAT 30 (K180051) to its predicate devices (XSTAT 30 and XSTAT 12, K170334). The "acceptance criteria" here are essentially that the new device performs similarly to or better than the predicate device across various performance and safety metrics, and that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown based on your request, as best as the provided text allows:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" is the demonstration that the new device meets or exceeds those. The document states:
"The XSTAT 30 device is substantially equivalent to the predicate devices. The XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The Substantial Equivalence Summary tables below details and compares the XSTAT 30 to the predicate XSTAT devices."

The table provided directly compares the characteristics of the "New: XSTAT 30" and "Predicate: XSTAT 30 and XSTAT 12 (K170334)". In all categories, the specifications for the new device are either identical or shown to be an acceptable variation (e.g., slightly different dimensions/weight for a one-pack vs. a three-pack configuration, with similar underlying technology).

Therefore, the acceptance criteria are implicitly that the new XSTAT 30 performs equivalently in these areas, and the reported device performance is that it does.

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

This document describes a substantial equivalence submission, not a new clinical study with a defined test set for a new device. The performance data provided is primarily:

• Bench Testing: Mechanical testing on the XSTAT 30 applicator (Deployment Force, Plunger Axial Force, Tip Tensile Strength, Fluid Immersion). No specific sample sizes are mentioned, but these are typically done on multiple units.
• Minisponges: The minisponges are stated to be "identical to the predicate devices." Therefore, prior testing for the predicate (K170334), including radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure, and viral inactivation, is referenced.
• Biocompatibility Testing: Similar to minisponges, this testing was performed on the predicate devices (K170334) and referenced, as the minisponges are identical.
• Animal Study: The animal performance testing was also conducted on the predicate devices (K170334) and referenced.

There is no specific test set sample size or data provenance mentioned for a new clinical study in this document. The "tests" are primarily bench and referenced pre-clinical data from the predicate.

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. This is not a study involving expert readers or ground truth establishment in the context of an AI/ML device or diagnostic test.

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

Not applicable. This is not a study involving expert 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

Not applicable. This is not an AI/ML device or a diagnostic device where MRMC studies would typically be conducted.

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

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

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

For the chemical and mechanical properties, the "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility). For clinical effectiveness, it refers to the performance demonstrated in animal studies and potentially human experience with the predicate devices, against which the new device is deemed "substantially equivalent" because its active components and mechanism of action are identical.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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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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Intended Use:

The XSTAT 30 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 30 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 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 for immediate life-threatening bleeding 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 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.

The XSTAT 30 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 92 mini-sponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The compressed regenerated cellulose sponge is coated with chitosan. Upon contact with blood, the mini-sponges absorb blood and, if unencumbered, are capable of expanding to a pre-compressed height of 40-50 mm within approximately 20 seconds. A radiopaque marker is embedded into a circular surface of the mini-sponges to render each sponge detectable via X-ray. The XSTAT 30 dressing includes an applicator that facilitates delivery of the mini-sponges to external bleeding wounds. Three applicators filled with the XSTAT 30 dressing (i.e., mini-sponges) are packaged in a sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°.

For the treatment of severe bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT 30 sponges are applied to the wound using the applicator. Once applied to the wound, the XSTAT 30 sponges absorb blood and expand, thereby packing the wound. All mini-sponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the mini-sponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every mini-sponge has been removed.

The provided document is a 510(k) summary for the XSTAT 30 device and does not contain detailed information about a study with acceptance criteria and reported device performance in the way typically found for AI/ML device evaluations. This document declares substantial equivalence to a predicate device (XSTAT, K130218) primarily based on identical technological characteristics and similar intended use, with a change to indications for use to include the civilian population.

Therefore, many of the requested points, particularly those related to a direct study proving device performance against acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies, are not present in this regulatory submission.

However, I can extract the relevant information regarding performance data and substantial equivalence as described in the document.

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

The document states: "The technological characteristics for XSTAT 30 are identical to the predicate device. Thus, the performance testing of the XSTAT 30 has been demonstrated by the clearance of the XSTAT predicate device. The testing provided in the cleared XSTAT notification (K130218) is incorporated herein by reference."

This means that the device (XSTAT 30) is considered to meet acceptance criteria by demonstrating substantial equivalence to its predicate device (XSTAT). The performance criteria mentioned relate to the inherent properties and safety of the device rather than a measurable diagnostic accuracy outcome.

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 provided in the document as it references performance testing from the predicate device (K130218) and does not detail a new clinical study. The performance testing mentioned refers to bench and biocompatibility tests.

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 applicable/provided. The performance evaluation is based on device characteristics and biocompatibility, not expert-adjudicated diagnostic results.

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

This information is not applicable/provided.

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 applicable/provided. The device is a hemostatic sponge, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable/provided.

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

For the biocompatibility and material properties, the "ground truth" would be established by the results of standardized tests (e.g., ISO 10993 series) showing lack of toxicity, irritation, etc. For the expansion capabilities, the ground truth would be direct measurement of expansion time and volume. This is not "ground truth" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device's evaluation.

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

This information is not applicable/provided.

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XSTAT is a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT is a temporary device for use up to four (4) hours until surgical care is acquired. XSTAT is intended for use in the battlefield.

XSTAT consists of three sterile, syringe-style applicators containing compressed cellulose sponges with an absorbant animal-derived coating. The applicators facilitate fast delivery of the sponges into bleeding wounds. The black, telescoping handle is pulled away from the barrel of the applicator to prepare for sponge deployment. The tip of the applicator is placed into the wound track as close as possible to the source of bleeding before pushing the handle to deploy the sponges. Trained emergency responders may apply up to three applicators of sponges into junctional wounds in the groin or axilla as needed to completely pack the wound.

Each applicator houses 92 non-absorbable, expandable sponges for a total of 276 sponges per device (see Figure 1). Each sponge absorbs 3 ml of blood and a single applicator is therefore capable of absorbing approximately 300 ml. The sponges rapidly expand in length (see Figure 2) upon contact with blood or fluid to fill the wound cavity and thereby provide a physical barrier and pressure that facilitate formation of a clot. Once hemostasis is achieved, a standard occlusive dressing is applied before transporting the patient to a medical facility where surgery is performed to definitively repair the wound. The sponges are intended for temporary use up to four hours until surgical care is acquired. All sponges must be removed from wounds manually and/or with forceps by a surgeon with the capability and equipment for achieving proximal and distal vascular control. For easy detection via x-ray, one face of each tablet contains radiopaque filaments in an "x" pattern (see Figure 2). To confirm removal of all sponges and any applicator tips, a radiograph is required prior to wound closure with imaging in more than one plane recommended.

The provided document describes the acceptance criteria and the studies conducted to demonstrate that the XSTAT device meets these criteria. The studies are primarily non-clinical (bench testing) and animal studies, along with human factors testing. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance, as the device is a physical medical device, not an AI/software.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is drawn from various tables and sections of the document. Due to the extensive and varied nature of the acceptance criteria and results (including qualitative descriptions), this table will summarize key findings from the "Biocompatibility," "Stability/Sterility," and "Performance Testing - Bench" sections. Specific quantitative acceptance criteria are often marked as "(b)(4) Trade Secret/CCI" in the original document, so general "PASS" results are reported where specific numbers are not publicly available.

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