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Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.

This 510(k) Premarket Notification is for the Aesculap Optilene Nonabsorbable Surgical Suture. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state specific sample sizes for each mechanical or biocompatibility test. It broadly states that "Tests were conducted for diameter, tensile strength, and needle attachment" and that "Biocompatibility testing... includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week)."

The data provenance is not explicitly stated in terms of country of origin. Given that it's a 510(k) submission to the FDA, the testing would generally be expected to comply with US regulatory standards, but the physical location of labs or studies isn't provided. The studies are prospective in nature, as they are specifically conducted to support this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable in this context. The "ground truth" for suture performance is established by recognized standards, specifically USP 35 (United States Pharmacopeia) for mechanical properties and ISO 10993-1 for biocompatibility. These standards define the acceptable range or nature of results for the device to be considered safe and effective. Expert consensus is not used to establish these fundamental criteria; rather, the tests are performed in accordance with these pre-defined, validated methodologies.

4. Adjudication Method for the Test Set:

Not applicable. The performance is measured against objective, quantitative standards (USP 35) or standardized test outcomes (ISO 10993-1). There is no "adjudication" in the sense of reconciling differing expert opinions, but rather a direct comparison of test results to predetermined acceptance limits.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study investigates human reader performance, typically with medical imaging or diagnostic devices. This device is a surgical suture, and its performance is evaluated through laboratory and preclinical (biocompatibility) testing, not by human readers interpreting data.

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

Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to the physical and chemical properties of the suture itself, measured through standalone laboratory and biocompatibility tests.

7. The Type of Ground Truth Used:

The ground truth used is primarily based on:

• Established Standards: USP 35 for mechanical properties (diameter, tensile strength, needle attachment).
• International Standards for Biocompatibility: ISO 10993-1 for biological safety.
• Chemical Equivalence: Comparison of chemical characterization results of the raw materials to those of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device submission.

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The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.

The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be cut. The cannula allows the ligation loops to be placed and tightened from a single central incision. The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula. This assembly is packaged in a paper envelope and sealed in a Tyvek - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.

The provided text describes a medical device, the VascuLoop Two Tie Endoscopic Ligation System, and its substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be seen for a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is a common pathway for medical device approval in the US. This means the primary "acceptance criterion" is that the new device is as safe and effective as the predicate device. The evidence provided is largely comparative.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in this type of submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The text mentions "functional performance testing" and a "simulated use cadaver study." It does not specify how many cadavers or how many ligations were performed.
• Data Provenance: The "simulated use cadaver study" implies a prospective, controlled experimental setting, likely in a laboratory rather than a clinical setting. The country of origin is not specified, but given the US submission, it's presumed to be within a regulatory framework compatible with the FDA.

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. For this type of device (a surgical tool), "ground truth" would likely be established through objective measurements of ligation integrity, ease of use, and mechanical strength in the cadaver study, rather than through expert consensus on diagnostic interpretations. The evaluators of the cadaver study are not described.

4. Adjudication method for the test set

• Not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's subjective interpretation involved, such as in diagnostic imaging studies to establish ground truth for ambiguous cases. For a mechanical device performance study, objective measurements are usually the primary evidence.

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 study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by the AI. The VascuLoop is a surgical tool, not a diagnostic AI.

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

• Not applicable. This device is a physical surgical tool and does not involve an algorithm or AI. Its performance is always "human-in-the-loop," as a surgeon uses it.

7. The type of ground truth used

• For the "functional performance testing" and "simulated use cadaver study," the ground truth would likely be based on:
  • Objective Measurements: Such as tensile strength of the ligated vessel, integrity of the knot, ease of deployment, and absence of damage to surrounding tissue, compared to established benchmarks or the predicate device.
  • Observational Data: From the cadaver study regarding the practical application and outcome of using the device.

8. The sample size for the training set

• Not applicable. This device is a surgical tool, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set for an algorithm is involved.

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The MEMOMETAL Micro ARIM® is indicated for

• Hand: Ligament reconstruction
• Ankle: Midfoot reconstruction
• Foot: Hallux Valgus reconstruction
• Wrist: Scapholunate Ligament reconstruction
• Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

MEMOMETAL Micro ARIM® anchors are single-use bone fixation appliances intended to be permanently implanted. Micro ARIM® anchors made of shape memory nickel titanium alloy. MEMOMETAL Micro ARIM anchors can be used in 2 versions with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed below: Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester suture (K012201) Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire suture (K041589) MEMOMETAL Micro ARIM® Anchors adopt an opened position after introducing into bone which allows a permanent fixation, thus supporting a secure ligament restoration.

The provided text is a 510(k) Premarket Notification for a medical device (MEMOMETAL Micro ARIM® anchor), not a study assessing AI software performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on material, design, function, and intended use, rather than presenting a clinical study with detailed performance metrics against acceptance criteria that would typically be associated with software or AI claims.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be extracted. This document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against a clinical outcome. It focuses on conforming to a material standard and substantial equivalence to a predicate device.

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

• Cannot be extracted. This document does not describe a clinical study with a test set.

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)

• Cannot be extracted. This document does not describe a clinical study requiring expert-established ground truth.

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

• Cannot be extracted. This document does not describe a clinical study with an adjudication method.

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

• Cannot be extracted. This document is for a physical bone anchor, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported here.

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

• Cannot be extracted. This document is for a physical bone anchor, not an algorithm.

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

• Cannot be extracted. This document does not describe a clinical study requiring ground truth.

8. The sample size for the training set

• Cannot be extracted. This document does not describe an AI training set.

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

• Cannot be extracted. This document does not describe an AI training set or its ground truth establishment.

What can be inferred from the document regarding "acceptance criteria" and "study":

The document focuses on demonstrating that the MEMOMETAL Micro ARIM® anchor meets general safety and effectiveness requirements by:

• Material Conformance: "THE MEMOMETAL Micro ARIM® conform to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants." This is the primary acceptance criterion explicitly stated for the material. The "study" proving this would be material testing to verify compliance with this ASTM standard.
• Substantial Equivalence: "[THE MEMOMETAL Micro ARIM®] are substantially equivalent to their predicate devices MITEK MiniQUICKANCHOR Plus in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness." This is the overarching "acceptance criterion" for 510(k) clearance. The "study" demonstrating this involves a comparison of the new device to the predicate across various attributes as detailed in the submission, confirmed by the FDA's review.

In summary, for K071941, the "acceptance criteria" revolve around conforming to an industry standard for the material and demonstrating substantial equivalence to a legally marketed predicate device, rather than specific clinical performance metrics from a device-specific study against a defined ground truth.

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