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The RAM® COR-SUTURE® QUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.

The COR-SUTURE® OUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.

LSI SOLUTIONS® offers both the RAM® COR-SUTURE® QUICK LOAD® surgical suture, which is a non-absorbable polytetrafluoroethylene (PTFE)-coated, braided polyester surgical suture, and the COR-SUTURE® QUICK LOAD® surgical suture, which is available as either a PTFE-coated, braided polyester surgical suture or a monofilament, uncoated polypropylene surgical suture. The RAM® COR-SUTURE® QUICK LOAD® surgical suture is also supplied with an optional pre-attached PTFE pledget that is used to aid in suture buttressing and to mechanically secure and support the suture in fragile tissue, increasing the suture holding strength. A short length of modified surgical stainless-steel tubing, called a "needle cap", is attached to each end of the suture for both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture. Relative to the COR-SUTURE® QUICK LOAD® device, the RAM® COR-SUTURE® QUICK LOAD® device additionally includes a needle cap holder to secure the optional pledget and needle caps in the suture tray. Both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture also include a detachable clear suture tube to keep the suture from tangling. The needle caps are removed from the sutures and discarded once suturing is completed as they are not intended for implantation in the patient; only the suture and pledget are implantable of components.

Both devices are packaged for single patient use and are provided sterile by means of a validated ethylene oxide (EO) cycle. The polyester RAM® COR-SUTURE® QUICK LOAD® surgical suture is offered undyed (white), dyed green with the FDA approved colorant D&C Green No. 6. or striped green/white; all of which are offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polyester COR-SUTURE® QUICK LOAD® surgical suture is available undyed (white) or dyed green with the FDA approved colorant D&C Green No. 6 and will be offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polypropylene COR-SUTURE® QUICK LOAD® surgical suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 3-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures, with needle caps removed, contains implantable components which are considered MR safe. The implantable polyester and polypropylene sutures and PTFE pledget material are non-metallic and non-conducting materials and therefore, considered MR safe.

This document describes the RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures. It concerns a 510(k) premarket notification for these devices, asserting their substantial equivalence to a predicate device.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample size used for the benchtop testing test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the testing was conducted as recommended by the FDA Guidance for Industry, Class II Special Control Guidance Document.

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):

This information is not applicable. The device is a surgical suture, and "ground truth" as typically used in AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of device and its performance testing. The performance is assessed against established physical standards and biocompatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the physical and biocompatibility testing of a surgical suture.

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:

This information is not applicable. This is a medical device (surgical suture) and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the benchtop testing, the "ground truth" or standard for performance is the United States Pharmacopeia (USP), Monograph for Non-Absorbable Sutures, specifically sections from the USP General Chapter on Physical Tests.

For biocompatibility testing, the standards are ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and the FDA Guidance for Industry, Use of International Standard ISO 10993-1.

8. The sample size for the training set:

This information is not applicable. There is no concept of a "training set" for physical and biocompatibility testing of a surgical suture.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for this type of device testing.

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The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.

LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.

This document does not describe a study involving an AI/Medical Device that requires the establishment of ground truth, expert consensus, or multi-reader multi-case studies. Instead, it is a 510(k) premarket notification for a surgical suture, the RD QUICK LOAD SUTURE, asserting its substantial equivalence to a previously cleared predicate device.

The acceptance criteria and proof of substantial equivalence for this suture device are based on non-clinical performance testing and biocompatibility assessment, not on clinical performance studies involving a test set, expert consensus, or multi-reader studies as one would expect for an AI/Medical Device.

Here's why and what information is provided:

1. Acceptance Criteria and Device Performance (for a Suture)

The acceptance criteria for the RD QUICK LOAD SUTURE are based on established standards for surgical sutures. The performance of the device is evaluated against these standards.

2. Sample Size and Data Provenance for Testing:

• Data provenance: The document states "Biocompatibility results from Teleflex® Medical OEM were leveraged." This implies testing was conducted by the raw material supplier.
• The specific sample sizes for the USP and biocompatibility testing are not explicitly stated in this document. These would typically be defined by the relevant standards and internal test protocols. The nature of this 510(k) summary means highly detailed test parameters are usually omitted, with the FDA reviewing the full test reports.
• The tests are non-clinical (benchtop and lab-based biocompatibility), not clinical.

3. Number of Experts/Qualifications (Not Applicable for Suture Evaluation):

This information is not relevant to the evaluation of a surgical suture's substantial equivalence based on physical and biocompatibility properties. There are no "experts" establishing ground truth in the context of image interpretation or diagnosis.

4. Adjudication Method (Not Applicable):

Not applicable for a medical device cleared through substantial equivalence based on physical and biological testing.

5. MRMC Comparative Effectiveness Study (Not Applicable):

• No MRMC study was done. This is a surgical suture, not a diagnostic AI device. There are no "human readers" to improve with AI assistance. Clinical studies were deemed unnecessary.

6. Standalone Performance (Not Applicable as AI):

This is not an AI/algorithm. Its performance is its tensile strength, knot security, and biocompatibility, which are tested through benchtop methods defined by USP standards.

7. Type of Ground Truth (for Suture Properties, not a Diagnostic):

• The "ground truth" for the suture's performance is established by validated physical test methods (USP standards) and biocompatibility testing against ISO standards.
• For the claim of substantial equivalence, the "ground truth" is also the performance of the predicate device, against which the new device is compared.

8. Sample Size for Training Set (Not Applicable - No AI/Machine Learning):

This device does not involve a "training set" in the context of AI or machine learning. It is a manufactured physical good.

9. How Ground Truth for Training Set was Established (Not Applicable):

Not applicable, as there's no training set for an AI model.

In summary, this FDA clearance document is for a traditional medical device (surgical suture) demonstrating chemical and physical equivalence to a predicate device, not an AI-powered diagnostic tool. Therefore, many of the requested criteria, which are standard for AI/ML device evaluations, are not applicable here.

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MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair.

The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, stainless steel needle and a plastic handle.

The provided text is a 510(k) summary for the MR-III Suture Retention Device. It does not contain information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria. The document primarily focuses on the administrative aspects of a 510(k) submission, including company contact, device description, predicate devices, and intended use as well as the FDA's decision letter. Studies proving performance are not part of the 510(k) Summary. Therefore, I cannot generate the requested table and study details from the provided input.

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