Search Results
Found 2 results
510(k) Data Aggregation
(256 days)
The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization.
Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.
The Mi-CHORD™ System, shown in Figure 1, is a sterile, single use system, including the Mi-STITCH™ suturing device with its loaded LS-5™ expanded polytetrafluoro-ethylene (ePTFE) suture (Figure 2) and the Mi-KNOT™ device with its loaded Mi-KNOT™ titanium fastener (Figure 3).
The provided text describes a medical device (Mi-CHORD System) and its non-clinical and clinical performance data. However, it does not describe an AI/ML-based device, nor does it contain information about "acceptance criteria" in the context of an AI/ML study, or any "study that proves the device meets the acceptance criteria" in that context.
The document primarily focuses on:
- Device Description: The physical components and their functionality (Mi-STITCH and Mi-KNOT devices, ePTFE suture, titanium fastener).
- Nonclinical/Bench Studies: Biocompatibility, shelf life/sterility, and various engineering bench tests demonstrating mechanical performance, reliability, durability, and material properties. These are traditional engineering and material science tests for a physical medical device.
- Clinical Information: A single-center, single-cohort feasibility study conducted outside the United States (OUS) with 12 patients, focusing on operative times, echocardiographic outcomes, adverse events, and mortality in mitral valve repair.
- Regulatory Aspects: De Novo classification request, indications for use, risks to health, and special controls.
Since the prompt asks for information related to an AI/ML device's acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), the provided text does not contain the information requested in points 2-9 of your prompt. It describes the validation of a physical surgical device, not a classification algorithm or AI system.
Therefore, I cannot fulfill the request as presented, as the necessary information for an AI/ML device's acceptance criteria and proving study is absent from the provided text.
Ask a specific question about this device
(161 days)
The LS-5™ ePTFE Suture is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery.
Each LSI SOLUTIONS® LS-5™ ePTFE sterile surgical suture with 2 ferrules is held in a customized tray, with a suture release feature and is intended for single patient use. The LS-5™ ePTFE Suture is designed to enable the rapid, easy and reliable loading of suture into compatible LSI SOLUTIONS® Suture Placement Devices. LS-5™ ePTFE Suture is a non-absorbable, monofilament expanded polytetrafluoroethylene (ePTFE) suture. A short length of modified surgical stainless steel tubing, called a ferrule, is attached to each end of the suture for interfacing with LSI SOLUTIONS® Suture Placement Devices. The LS-5™ ePTFE Suture also includes a detachable clear suture tube to keep the suture from tangling. The LS-5™ ePTFE Suture is undyed and contains no additives. No significant loss in tensile strength retention occurs in vivo. The LS-5TM ePTFE Suture is MR safe.
This document describes the FDA's 510(k) clearance for the LS-5™ ePTFE Suture, a Class II medical device. The clearance is based on demonstrating substantial equivalence to a predicate device, the W. L. Gore and Associates Inc. GORE-TEX™ Suture. The information provided outlines the performance testing conducted to support this equivalence.
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LS-5™ ePTFE Suture primarily rely on meeting the United States Pharmacopeia (USP) monograph for Nonabsorbable Sutures and demonstrating comparability to the predicate device, GORE-TEX™ Suture.
| Acceptance Criterion | Reported LS-5™ ePTFE Suture Performance |
|---|---|
| Mechanical Performance: | |
| USP Sutures - Tensile Strength requirements | LSI has performed testing to demonstrate the LS-5™ ePTFE Suture is comparable to the predicate device for tensile strength and complies with USP requirements for Nonabsorbable Sutures Section Sutures - Tensile Strength for 4-0 suture (as the predicate, CV-5 GORE-TEX® Suture, is promoted as comparable to USP size 4-0 surgical suture). |
| USP Sutures – Needle Attachment requirements (for ferrule attachment) | Ferrule Attachment complies with the requirements for standard needle attachments as defined in Sutures – Needle Attachment . |
| USP Sutures - Diameter requirements | The LS-5™ ePTFE Suture is offered with a surgical suture diameter comparable to the predicate device, CV-5 GORE-TEX® Suture, which is designated to approximately correlate with a surgical suture diameter of USP size 2-0. While the internal microporous airspaces of ePTFE slightly exceed USP requirements, LSI has performed testing to demonstrate the LS-5™ ePTFE Suture is comparable to CV-5 GORE-TEX® Suture for surgical suture diameter. The labeling will include a tabular comparison of its diameter and tensile strength to the predicate and USP requirements for 2-0, 3-0, and 4-0. |
| Biocompatibility: | |
| Compliance with ISO 10993-1:2009 Standards | Biocompatibility evaluation conducted in accordance with FDA Guidance for Industry, Use of International Standard ISO 10993-1:2009. The LS-5™ ePTFE Suture is classified as an implant device, contacting blood, for a permanent duration, identical to the predicate device. |
| Biocompatibility Endpoints (Systemic Toxicity, Intracutaneous, Muscle Implantation, Cytotoxicity, Sensitization, Irritation, Pyrogen, Hemocompatibility) | Leveraged existing biocompatibility testing from the ePTFE suture material manufacturer for USP Systemic Toxicity, USP Intracutaneous Toxicity, and USP Muscle Implantation Studies. Additionally, LSI conducted Cytotoxicity, Sensitization, Irritation, Rabbit Pyrogen, and Hemocompatibility testing. A combination of testing and risk assessment was completed to ensure biocompatibility. |
| Other Performance: | |
| Compatibility with LSI Suture Placement Devices | LSI has performed testing to ensure that the LS-5™ ePTFE Suture is compatible with the LSI SOLUTIONS® Suture Placement Devices. |
| Bacterial Endotoxins Testing (BET) | BET performed to confirm the subject device does not contain gram-negative endotoxins. |
| Stability Testing | Stability testing performed to support the labeled 2-year shelf life. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of sutures tested) for each individual mechanical or biocompatibility test. It indicates that testing was performed "to demonstrate" compliance and comparability.
The data provenance for the biocompatibility testing includes:
- Existing data: Leveraged from the manufacturer of the ePTFE suture material (likely prospective testing originally conducted by the material manufacturer).
- New data: Conducted by LSI Solutions (prospective testing).
The document does not specify the country of origin for the data, but given it's an FDA submission, the testing would generally align with international standards recognized by the FDA.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the presented document. The ground truth for this device's performance is established by objective, standardized measurements against recognized industry standards (USP monographs for sutures) and direct comparison to a predicate device, not by expert consensus or interpretation of subjective data. Physical and chemical properties are measured directly.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., medical image interpretation) where multiple experts might disagree. In this case, performance is measured against objective standards.
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
There was no MRMC comparative effectiveness study performed. This device is a surgical suture, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There was no standalone (algorithm-only) performance study done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The ground truth used for demonstrating the LS-5™ ePTFE Suture's performance is:
- USP Monograph Standards: Specific quantitative requirements for suture diameter, tensile strength, and needle attachment.
- Predicate Device Characteristics: Direct comparison of the LS-5™ ePTFE Suture's physical properties (diameter, tensile strength, material composition) to those of the legally marketed GORE-TEX™ Suture.
- International Biocompatibility Standards: Compliance with ISO 10993-1:2009 and related biological endpoints.
8. The sample size for the training set
This section is not applicable. This device is not an AI/ML model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1