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GalaSTITCH™ Absorbable Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.

This document is a 510(k) summary for the GalaSTITCH Absorbable Monofilament Suture. It states that the device is identical to a previously cleared predicate device, TephaFLEX Absorbable Monofilament Suture (K082178), in terms of materials, design, and manufacturing processes. The submission is a "Special 510(k)" primarily for rebranding and a minor clarification to a contraindication statement in the labeling.

Therefore, the information requested regarding acceptance criteria and study data to prove device performance is not present in this document because no new testing was performed for this 510(k) submission.

The document explicitly states:
"There have been no changes to the P4HB material, design specifications, or the manufacturing processes for purposes of this submission. The GalaSTITCH suture is identical to the TephaFLEX predicate; therefore, no additional testing was necessary to demonstrate safety and performance."

This means that the safety and performance of the GalaSTITCH suture are based on its equivalence to the predicate device, TephaFLEX, for which testing would have been performed and documented in its original K082178 510(k) submission.

In summary, none of the requested information (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or training set ground truth establishment) can be extracted from this specific document.

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VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye.

VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.

The VisiPlugST is a punctum plug designed for temporary occlusion of the tear drainage system.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VisiPlugST were based on comparing its material properties to an existing predicate device (Collagen Plugs for the Lacrimal Efficiency Test, K895342) and referenced predicate devices (Maxon, Sterile Synthetic Absorbable Sutures K990951 and CaproSyn Suture K032586). The primary performance characteristics evaluated were strength retention and mass loss degradation rates.

2. Sample Size and Data Provenance

The document does not explicitly state a separate "test set" and a "training set" in the context of an algorithm or image analysis. The data provided refers to nonclinical tests conducted to assess the material properties of the VisiPlugST (Glycoprene® MG23) against its predicate device (gut suture).

• Sample Size for Test Set: Not explicitly stated for each test, but studies were conducted to compare strength and mass loss degradation rates.
• Data Provenance: The studies were nonclinical tests comparing material properties. The country of origin and whether it was retrospective or prospective is not specified, but it refers to laboratory testing of materials.

3. Number of Experts and Qualifications for Ground Truth Establishment

This device is not an AI/ML device that requires expert review for ground truth establishment. The performance data is based on laboratory physical and chemical testing of the device material.

4. Adjudication Method for Test Set

Not applicable as this is not a diagnostic device requiring human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established through laboratory measurements and scientific analysis of the material properties (strength retention, mass loss) and biocompatibility of the Glycoprene® MG23 material, compared against established values and properties of the predicate device's material (gut suture).

8. Sample Size for the Training Set

Not applicable, as this device does not involve a "training set" in the context of an algorithm.

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

Not applicable.

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V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.

The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The input document is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This document does not describe the acceptance criteria or results of a study in the format requested. It is a regulatory submission outlining the device description, indications, and substantial equivalence to predicate devices, but lacks detailed performance data with specific acceptance criteria and study results. Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

Specifically, the "Performance Data" section merely states: "Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended." This general statement does not provide the specific metrics, criteria, or study outcomes needed to answer your request.

To fulfill your request, I would need a document that includes:

• A table or section explicitly listing acceptance criteria for various performance metrics (e.g., tensile strength, absorption rate, knot security, biocompatibility).
• Detailed results of the studies performed to demonstrate compliance with these criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, and study designs (e.g., standalone, MRMC) if applicable.

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