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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