(463 days)
The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
The document provided is a 510(k) Summary for the Ax-Surgi Surgical Hemostat and outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not detail acceptance criteria in the form of specific quantitative metrics for comparison with the device performance. Instead, it lists studies and their general positive outcomes ("Pass," "Non-cytotoxic," "successful safety and performance assessment").
Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific quantitative metrics. The document describes a series of tests performed and provides a qualitative outcome for each.
Here's an analysis of the provided information related to the other requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted above, the document does not present quantitative acceptance criteria. Instead, it lists various tests and their qualitative outcomes.
| Testing | Reported Device Performance |
|---|---|
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Genotoxicity | Non-mutagenic |
| Acute Systemic Toxicity | Non-toxic |
| Implantation | Non-toxic |
| Pyrogenicity | Non-pyrogenic |
| Subacute Toxicity | Non-toxic |
| Intracutaneous Reactivity | Non-irritating |
| Hemolysis Test | Non-hemolytic |
| Animal Studies (Pilot & Pivotal) | Achieved successful safety and performance assessment, successful hemostasis in swine liver resection model displaying class III or class IV bleeding. Demonstrated safety and hemostatic performance comparable to standard of care. No evidence of vascular obstruction or embolization. Inflammation and adhesions were as expected and substantially equivalent to standard of care. Radiographically detectable. |
| Moisture Content | Pass |
| Tensile Strength | Pass |
| Integrity | Pass |
| Radiopacity | Pass |
| In vitro Clot Assessment | Pass |
| Particulate Release | Pass |
| Absorbency | Pass |
| pH | Pass |
2. Sample size used for the test set and the data provenance:
- Animal Studies (Test Set): Two animal studies were conducted:
- Pilot Study: "To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)" - Sample size is not explicitly stated, but it's a "pilot study."
- Pivotal Study: "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day." - Sample size is not explicitly stated.
- Data Provenance: The animal studies were conducted in a porcine (swine) model. Information on the country of origin or whether the data was retrospective/prospective is not provided, although preclinical animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies are described as animal studies assessing physiological outcomes (hemostasis, inflammation, toxicity, adhesion), which would typically be assessed by veterinarians, pathologists, and researchers involved in the study, but the specific number and qualifications are not listed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. The adjudication method for the preclinical animal studies is not specified.
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, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. The device is a surgical hemostat, not an imaging or diagnostic AI device. The comparison was to a "standard of care" in animal models.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a physical hemostat, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal studies, the ground truth was established through direct observation of physiological outcomes (e.g., successful hemostasis, inflammation, adhesion formation, systemic/local toxicity) and histopathological examination of tissues over observation periods (48 hours and 28 days). This would align with pathology and direct outcomes data from the animal model.
8. The sample size for the training set:
- This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the development and testing of this type of hemostat.
9. How the ground truth for the training set was established:
- This information is not applicable, as explained in point 8.
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.