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The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

This document does not contain any information about an AI/ML device, therefore, an answer to the request cannot be generated. It describes a traditional medical device, the Monik™ - Disposable Endoscopic Trocar, and its substantial equivalence to predicate devices based on design, materials, sterilization, packaging, and performance testing.

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1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The provided text describes the acceptance criteria and the studies performed for two medical devices: PINION™ PDO Knotless Suture and PINION™ PGA-PCL Knotless Suture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on comparison to predicate devices and adherence to USP (United States Pharmacopoeia) and ISO standards. The "Reported Device Performance" column reflects whether the subject device meets these criteria. Since the document states "No change," "Identical," or indicates the subject device provides "more safety" than the predicate device, it implies successful meeting of the criteria.

PINION™ PDO Knotless Suture

PINION™ PGA-PCL Knotless Suture

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

The document details performance testing for both sutures, including:

• Diameter USP
• Tensile strength USP
• Needle attachment USP
• Suture Length
• Number of barbs per linear length of suture
• Barb size (length)
• Barb size Direction
• Barb Angle
• Barb holding strength
• Sterility USP
• Biocompatibility as per ISO 10993-1

However, the specific sample sizes used for each of these performance tests are not explicitly stated in the provided document.

The document mentions "implantation studies in animals" for the predicate devices to establish in-vivo tensile strength retention and absorption profiles. For the subject devices, it explicitly mentions "The results of in vitro study using PINION™ PDO Knotless Suture" and "PINION™ PGA-PCL Knotless Suture retains approximately 62 % of its original strength 7 days post implantation," implying similar in-vitro or animal studies were conducted for the subject devices to demonstrate equivalent performance.

The data provenance is related to the manufacturing country, which is India (M/s. Meril Endo Surgery Private Limited, Gujarat, India). The studies would therefore likely align with standard regulatory practices and be conducted to meet FDA requirements for prospective testing to demonstrate device performance and safety. The document does not specify if any retrospective data was used for direct performance comparison of the subject device, beyond referencing predicate device characteristics.

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 section is not applicable to this type of medical device submission. The devices are surgical sutures, and their performance is evaluated through measurable physical and biological properties against established standards (USP, ISO) and comparison to predicate devices, not through expert-reviewed interpretations of images or clinical outcomes that require "ground truth" established by human experts in the same way an AI diagnostic device would.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers and AI for diagnostic or screening tasks to establish a consensus "ground truth." For surgical sutures, the assessments are based on objective physical measurements and biological tests, not subjective interpretations requiring adjudication.

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 section is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance for human readers. These sutures are physical medical devices, not diagnostic software.

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

This section is not applicable. This question pertains to AI/software device performance, which is not relevant to surgical sutures.

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

For these surgical sutures, the "ground truth" or reference standards are:

• United States Pharmacopoeia (USP) standards for properties like diameter, tensile strength, and needle attachment.
• ISO 10993-1 standards for biocompatibility.
• Established performance profiles of the legally marketed predicate devices (e.g., STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device) for characteristics like tensile strength retention and absorption rates.

These are objective, quantitative and scientifically established benchmarks or comparisons.

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. Surgical sutures are physical devices, not AI/ML systems, and therefore do not have training sets.

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

This section is not applicable for the same reason as above.

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MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.

MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.

This document, K200452, pertains to the FDA 510(k) premarket notification for MERIL-BONEWAX™. As a 510(k) submission, it aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be typical for a new device requiring a PMA.

Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to performance tests designed to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of precise quantitative acceptance criteria with corresponding performance values for parameters like sensitivity, specificity, or quantifiable clinical outcomes. Instead, the acceptance criteria are generally qualitative or based on demonstrating equivalence to predicate devices and adherence to established standards.

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Mirus™ Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.

The Mirus™ Circular Stapler are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location. Mirus™ Circular Stapler is preloaded with Staples.

Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.

Mirus™ Hemorrhoids Circular Stapler is a set of instruments that places a circular row of titanium staples (double staggered) while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired. The Mirus™ Hemorrhoid circular stapler is preloaded with staples.

Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus™ Linear stapler are supplied separately

This FDA 510(k) clearance document outlines the substantial equivalence of the "Mirus Family of Surgical Staplers" to predicate devices, thus it doesn't contain a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/ML devices.

However, based on the provided text, we can infer the types of acceptance criteria used for this medical device (surgical staplers) and the nature of the "study" (preclinical performance testing) that demonstrates these criteria are met.

Here's an analysis structured per your request, with the understanding that specific numerical performance metrics are not given for acceptance criteria in this document, but rather a qualitative assessment of equivalence.

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

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

The document does not specify exact sample sizes for each performance test. It states "Simulated use testing was performed utilizing each device of the Mirus™ family of surgical staplers," implying that representative samples of each stapler type were tested.

• Test Set Sample Size: Not explicitly stated numerically for each test. Implied to be representative samples of each of the four device types (Circular, Linear Cutter, Hemorrhoidal Circular, Linear Stapler).
• Data Provenance: Preclinical / bench testing data generated by the manufacturer (M/s. Meril Endo Surgery Private Limited). The document does not specify country of origin for the test data generation itself, but the manufacturer is based in Gujarat, India. This generally implies retrospective testing performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this document. The "ground truth" for mechanical device performance tests is based on objective measurements against engineering specifications and international standards (e.g., staple height measurements, force measurements, chemical analyses for biocompatibility). It does not involve human expert interpretation in the same way an AI/ML diagnostic device would.

4. Adjudication method for the test set

This is not applicable as it refers to a consensus method for expert review, which is not relevant for preclinical mechanical performance and biocompatibility testing of this nature. All tests were conducted against pre-defined, objective criteria in relevant 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

This is not applicable. This document describes the clearance of surgical staplers, which are mechanical medical devices, not AI/ML-assisted diagnostic tools. Therefore, MRMC studies and "human readers" interpreting AI output are not relevant.

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

This is not applicable as the device is a mechanical surgical stapler, not an algorithm or AI product.

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

The "ground truth" for the preclinical performance tests is established by:

• Engineering specifications for dimensional, force, and staple formation characteristics.
• International standards (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging) which define acceptable limits and testing methodologies.

8. The sample size for the training set

This is not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications.

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

This is not applicable for the same reason as above. There is no training set for this type of device.

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The Mirus™ Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.

Mirus™ Ligating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.

Mirus™ Ligating clip are sterile, single use, implantable device made of implant grade titanium (ISO 5832-2 / ASTM F 67). The clips are available in various sizes with 6 clips packed in a single plastic cartridge.

Mirus™ Ligating clips are supplied with multiuse non sterile stainless steel Mirus™ Ligating Clip applier, allows the end user to ligate a wide range of vessels and tissue structures using the ligating clips

The provided document is a 510(k) premarket notification for a medical device called "Mirus™ Ligating Clip" and "Mirus™ Ligating Clip Applier." The document focuses on establishing substantial equivalence to predicate devices and describes various performance tests conducted. However, it does not contain a specific study that directly proves the device meets detailed acceptance criteria in the manner of a clinical trial or comparative effectiveness study with human readers assisting AI.

Here's the breakdown of the requested information based on the provided text:

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

The document lists performance tests but does not explicitly state numerical acceptance criteria or detailed results for all of them. It broadly states that the device was "subjected to the performance testing" and implies that these tests were passed, leading to the conclusion of substantial equivalence.

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

The document does not specify the sample sizes used for each of the performance tests. It also does not provide details on the data provenance in terms of country of origin or whether the studies were retrospective or prospective. These tests appear to be bench or lab-based rather than human clinical studies.

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 to the type of device and tests described. The tests are for the physical and biological characteristics of a ligating clip, not for an AI algorithm requiring expert ground truth in image interpretation or diagnosis.

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

This information is not applicable. The tests described are laboratory-based performance and biocompatibility assessments, not clinical studies requiring adjudication of outcomes by experts.

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 such study was conducted or mentioned in the document. This type of study is relevant for AI-powered diagnostic or assistive devices, not for a medical device like a ligating clip and applier.

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

This information is not applicable. The device is a physical medical device (ligating clip and applier), not an algorithm or AI system.

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

The document does not explicitly use the term "ground truth" in the context of expert consensus or pathology. For the performance tests (e.g., radial pull-off force, leakage), the "ground truth" would be established by physical measurement against predefined engineering or material specifications and standards (e.g., ISO, ASTM standards). For biocompatibility, the ground truth would be the results of standard biological assays according to established protocols.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI system that requires a training set.

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

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

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MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands

This looks like a 510(k) summary for a medical device (MERISTEEL™ Stainless Steel Surgical Suture). However, the document does not contain acceptance criteria for an AI/ML-driven device or study details proving those criteria are met.

The provided document describes a traditional medical device (surgical sutures) and outlines tests conducted to demonstrate equivalence to a predicate device, such as:

• **Diameter USP **
• **Tensile strength USP **
• **Needle attachment USP **
• Suture Length
• Biocompatibility as per ISO 10993-1

These are performance standards for the physical properties and biological safety of the suture material, not criteria related to AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document is about a conventional medical device submission.

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FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture. FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.

FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes. FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.

MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes. MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area

FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes. FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area

The provided document is a 510(k) premarket notification for surgical sutures (FILASILK, FILAMIDE, MERICRON XL, FILAPROP). It describes various aspects of the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about an AI/ML device. Therefore, I am unable to extract information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device, as these concepts are not applicable to the traditional medical devices described in this submission (surgical sutures).

The document is solely focused on demonstrating the substantial equivalence of surgical sutures to predicate devices based on material composition, design, performance (e.g., tensile strength, diameter), and biocompatibility. The performance data section refers to standard USP (United States Pharmacopoeia) requirements for sutures, not to performance metrics typical of AI/ML algorithms (e.g., sensitivity, specificity, AUC).

Since the core request is about an "AI/ML device," and the provided document is for traditional surgical sutures, I cannot fulfill the request as stated.

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MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.

MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular or neurological tissues.

MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.

FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate.

MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate.

MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture.

FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone).

FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone).

All sutures are available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.

This document is a 510(k) premarket notification for several types of absorbable surgical sutures (MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON). It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the typical acceptance criteria and study design for new AI/Medical Device effectiveness, as requested in your prompt (which often includes human reader studies, ground truth establishment by experts, and analysis of effect sizes), are not applicable to this type of regulatory submission.

Instead, the "acceptance criteria" here refer to meeting the performance specifications of the predicate devices and relevant USP standards, and the "study" is a series of laboratory and biocompatibility tests designed to show that the new devices perform equivalently to the predicates.

Here's a breakdown based on the provided document, addressing the closest analogues to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" but refers to compliance with USP (United States Pharmacopeia) standards and equivalence to predicate devices. The "reported device performance" is implicitly that the devices met these standards and demonstrated substantial equivalence.

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of sutures tested for tensile strength, number of animals for biocompatibility). It generally states that the "Surgical Suture was subjected to the performance testing as per USP requirements." USP standards often outline minimum sample sizes for specific tests.
• Data Provenance: The tests were conducted by the submitter, Meril Endo Surgery Private Limited, based in India. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of these new devices for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This type of submission (510(k) for surgical sutures) does not involve medical image interpretation or clinical diagnostic tasks that require experts to establish "ground truth" in the way an AI diagnostic device would. Performance is measured against physical and biological standards, not against expert medical consensus on a particular condition.

4. Adjudication Method for Test Set

• Not Applicable: There is no "adjudication method" in the sense of resolving conflicting interpretations by multiple human readers. Lab tests follow standardized protocols. Biocompatibility studies involve expert animal pathologists and toxicologists interpreting results, but this is standard scientific interpretation rather than "adjudication" of a ground truth label in an AI context.

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

• Not Applicable: No MRMC study was done. This device is a surgical suture, not a diagnostic imaging device or an AI-assisted tool meant to improve human reader performance.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable: This is not an algorithm or AI device. Its performance is measured directly through physical and biological testing.

7. Type of Ground Truth Used

• For physical properties (diameter, tensile strength, needle attachment, suture length): The "ground truth" is established by objective measurements against predefined scientific standards (USP specifications).
• For resorption profile: The "ground truth" or reference is the resorption profile of the legally marketed predicate device.
• For biocompatibility: The "ground truth" is established by standardized laboratory tests and expert interpretation of biological responses, adhering to recognized toxicology and biocompatibility guidelines (e.g., ISO 10993 series, though not explicitly cited in the summary, is standard practice). There isn't a single "ground truth" label; rather, it's a demonstration that the device's biological interactions fall within acceptable safety limits.

8. Sample Size for Training Set

• Not Applicable: There is no "training set" as this is not a machine learning or AI device.

9. How Ground Truth for Training Set was Established

• Not Applicable: As above, no training set or its associated ground truth.

In summary: The K172659 submission demonstrates substantial equivalence for absorbable surgical sutures by showing that these new devices meet established performance standards (primarily USP) and exhibit similar material compositions, designs, and intended uses to existing predicate devices. The evaluation focuses on laboratory testing and biocompatibility assessments rather than clinical performance studies that would involve human readers or AI algorithms.

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FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.

FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes.
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes.

Here's the breakdown of the acceptance criteria and study information for the Meril Endo Surgery Private Limited sutures, based on the provided document:

This document, a 510(k) Premarket Notification from the FDA, focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of novel performance criteria for a new type of device. Therefore, the "acceptance criteria" discussed are primarily regulatory and harmonized standards (USP requirements) that the device must meet to show it is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Filasilk, Filamide, Mericron XL, Filaprop (All are different types of non-absorbable surgical sutures)

Conclusion (from document): "Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes."

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

The document does not specify the exact sample sizes (number of sutures tested) for the performance criteria. It only states that "The Surgical Suture was subjected to the performance testing as per USP requirements."

The data provenance is not explicitly stated as country of origin, but the submitting company is Meril Endo Surgery Private Limited, located in Vapi, Gujarat, India. The testing was conducted to meet United States Pharmacopoeia (U.S.P.) standards, implying internationally recognized quality and testing protocols for medical devices. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of a prospective clinical trial.

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

Not applicable for this type of submission. This document pertains to physical and chemical performance standards of surgical sutures, not diagnostic or interpretive tasks requiring expert ground truth establishment (like image analysis by radiologists). The "ground truth" here is defined by objective, measurable USP physical and chemical property standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is against objective physical/chemical standards, not interpretive judgments that would require adjudication.

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. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the performance of diagnostic systems, often involving human readers.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on established, objective, and quantitative specifications outlined in the United States Pharmacopoeia (USP) for non-absorbable surgical sutures. This includes:

• USP for diameter
• USP for tensile strength
• USP for needle attachment
• General USP requirements for suture length, biocompatibility, sterility, and colorant compliance (e.g., 21 CFR references for dyes).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; there is no training set in the context of algorithm development.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a purpose. The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards (USP).

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