(175 days)
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:
- Minisponge Pouches (3 pouches per device)
- Applicator/Plunger
- 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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Minisponge and Sponge Pouch Expansion Rate meets specifications | Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance) |
| Minisponge Absorption Capacity meets specifications | Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance) |
| Sponge Pouch Durability meets specifications | Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance) |
| Sponge Pouch Expansion Force/Pressure in Gel Wound Model meets specifications | Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance) |
| Sponge Pouch Radiopacity meets specifications | Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance) |
| Applicator Deployment Force meets specifications | Deployment force testing (with and without fluid ingress, at both room temperature and low temperature conditions) was completed on the subject device’s applicator to verify the safety and efficacy of the applicator design. (Assumed to meet specifications) |
| Sterility Assurance Level (SAL) of 10⁻⁶ | Sterility Validation was performed per ISO 11137:2006 by the VDmax method with a VDmax of 25 kGy, demonstrating a SAL of 10⁻⁶. |
| Shelf-life stability meets standards | Evaluated for shelf life per accelerated and real-time stability testing in accordance with ASTM F1980-16. (Assumed to meet standards given clearance) |
| Biocompatibility in accordance with ISO 10993 | Biocompatibility testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Materials-Mediated Pyrogenicity were performed. (Assumed to meet standards given clearance) |
| Performance in femoral animal injury model is comparable to predicate device | A GLP animal study using a femoral animal injury model demonstrated that the XSTAT 30 Pouch is as safe and effective as the predicate device (XSTAT 30). |
| Human Factors and Usability | Usability and human factors have been demonstrated by the premarket clearance of the Predicate XSTAT 30 Gen2 device (K180051) as the applicator/plunger form factor and principles of operation are identical. User observations and feedback regarding ease of application/removal were gathered during the GLP Animal Study. |
| Overall safety and effectiveness compared to predicate | The XSTAT 30 Pouch is as safe and effective as the predicate devices, with differences not presenting new issues of safety or effectiveness. |
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.
§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
(a)
Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the biocompatibility of patient-contacting components.
(2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments.
(3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life.
(4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following:
(i) Material specifications.
(ii) Immunogenicity.
(iii) Viral inactivation for animal-derived materials.
(5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Absorption capacity.
(ii) Extent of swelling.
(iii) Mechanical properties.
(iv) Expansion force/pressure.
(v) Radiopacity.
(vi) Deployment/applicator functionality.
(6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested:
(i) Deployment.
(ii) Control of bleeding.
(iii) Radiopacity.
(iv) Retrieval.
(v) Assessment of local and systemic effects.
(7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds.
(8) Labeling must include:
(i) Specific instructions for deployment by emergency responders and retrieval by surgeons.
(ii) Warnings, cautions, and limitations needed for safe use of the device.
(iii) Information on how the device operates and the typical course of treatment.
(iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device.
(v) Appropriate imaging information to ensure complete retrieval of device.
(vi) An expiration date/shelf life.