(129 days)
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.
The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced through the liver with a tubular needle.
This document describes a 510(k) premarket notification for the "Hepatostat Set," an absorbable compression device intended for hepatic resection and traumatic liver injuries to reduce bleeding and achieve hemostasis. The submission references Biocompatibility and implant testing, performance testing, and risk assessment as the studies demonstrating safety and effectiveness.
However, the provided text does not contain the detailed acceptance criteria or numerical performance data typically found in a clinical study report for AI/ML devices. It focuses on the regulatory submission process for a physical medical device. Therefore, I will create a table outlining the stated acceptance criteria (which are more general compliance requirements for this type of device) and the reported device performance based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a traditional medical device (not an AI/ML device), the "acceptance criteria" are framed as regulatory and performance standards, and "device performance" refers to its ability to meet those standards as demonstrated by various tests.
| Acceptance Criteria (Stated Requirements) | Reported Device Performance (as per submission) |
|---|---|
| Biocompatibility: Device materials must be safe for implantation and not cause adverse biological reactions. (ISO 10993-1) | Demonstrated: Biocompatibility testing of the material in accordance with ISO 10993-1, including implantation testing at 3, 6, 12, and 15 months, demonstrates performance and biocompatibility of the device. |
| Device Performance (Mechanical/Functional): The device must function as intended (e.g., provide compression, degrade appropriately). | Demonstrated: In vitro testing demonstrates that the device performance. The absorbable strips and Safile sutures are broken down by hydrolysis, degrading into glycolic and lactic acid, which are subsequently metabolized and absorbed by the body. Complete absorption of sutures occurs between 60 and 90 days. Liver hemostasis is fairly rapid (approximately 15 days) and not impeded by reabsorption of components. |
| Sterility: The device must be sterile to a specified assurance level. | Ensured: Sterility testing ensures a sterility assurance level of 10^-6. |
| Risk Assessment: Potential risks associated with the device must be identified and mitigated. | Addressed: Risk assessment was performed. |
| Safety and Effectiveness: The device must be safe and effective for its intended use. | Concluded: Biocompatibility and implant testing, performance testing, and risk assessment demonstrate that the Hepatostat Set is safe and effective to use when used in accordance with the supplied instructions for use. |
| Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device. | Achieved: FDA reviewed the 510(k), found it substantially equivalent to predicate devices (Mar-Med Liver Strap K924223, Vicryl Synthetic Absorbable Surgical Suture K033746, Safil Synthetic Absorbable Surgical Suture K031286, MonoSyn Synthetic Absorbable Surgical Suture K011375), and issued K061796. |
Since the provided document is a 510(k) summary for a physical medical device and NOT an AI/ML device, the following points address what would typically be included for an AI/ML device but are not applicable or present in this specific document.
2. Sample size used for the test set and the data provenance:
- Not applicable for this device. This information is typically for AI/ML performance evaluation using real-world data. For this physical device, "test set" would refer to samples used in laboratory and animal in vivo studies, but specific numbers and provenance of "data" in the context of AI are not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this device. Ground truth for AI/ML models is often established by human experts labeling data. For this physical device, "ground truth" would relate to biological outcomes (e.g., hemostasis, tissue reaction) observed in pre-clinical studies, assessed by pathologists or researchers, not a consensus of experts on a dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this device. This term refers to how disagreements among annotators are resolved in AI/ML dataset creation.
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 for this device. MRMC studies are specific to evaluating AI/ML systems that assist human operators in tasks like image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for this device. This refers to the performance of an AI/ML algorithm independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biological studies mentioned (biocompatibility, implantation, hemostasis, absorption), the ground truth would be established through:
- Histopathology: for tissue reactions, inflammation, and degradation in implantation studies.
- Chemical analysis: for degradation products and absorption rates.
- Direct observation/measurement: of hemostasis efficacy in in vivo models.
- The document doesn't explicitly detail the methodology of "ground truth" for these pre-clinical studies but implies standard methods for material and medical device testing.
8. The sample size for the training set:
- Not applicable for this device. This information is for AI/ML model development.
9. How the ground truth for the training set was established:
- Not applicable for this device. This information is for AI/ML model development.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.