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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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Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Deknatel Silk Suture is a nonabsorbable, 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. Silk Suture is waxed, braided or twisted, and provided dyed (black) or undyed (natural white). Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.

This document is a 510(k) premarket notification for a medical device called "Deknatel Silk Surgical Sutures." It is not a study describing a device's performance against acceptance criteria in the typical sense of a clinical or AI performance study. Instead, it's a regulatory document demonstrating substantial equivalence to a predicate device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, training set details, etc.) are not applicable here.

However, I can extract the information that is present to describe the "acceptance criteria" and "study" as best as possible within the context of a 510(k) submission for a surgical suture.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (surgical suture), "acceptance criteria" are generally based on meeting recognized standards, specifically the United States Pharmacopeia (USP) requirements. The "device performance" is reported as compliance with these standards.

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

The document does not specify exact sample sizes for the "test set" in terms of physical units of sutures. The "test set" in this context refers to the samples of the Deknatel Silk Surgical Sutures that underwent non-clinical performance and biocompatibility testing. This kind of testing is typically performed internally by the manufacturer or by a contract lab.

• Sample Size: Not explicitly stated for each test, but standard statistical sampling is assumed for compliance testing.
• Data Provenance: The testing was "non-clinical" and likely conducted in a laboratory setting to demonstrate compliance with USP standards and biocompatibility guidelines. The country of origin of the data is not specified but would typically be from the manufacturer's or a certified testing lab's facilities. This is retrospective in the sense that the testing was completed before 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 concept is not directly applicable to this type of device and regulatory submission. "Ground truth" in this context is established by the predefined specifications of the USP standards and ISO 10993 guidelines, which are universal and do not typically require expert consensus on a case-by-case basis during testing for these physical and biological properties. The "experts" would be the scientists, engineers, and toxicologists who designed and conducted the tests and interpreted the results against the established standards. Their qualifications would be expertise in materials science, biomechanics, analytical chemistry, toxicology, and regulatory compliance.

4. Adjudication method for the test set

Not applicable. Testing against USP and ISO standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication process by multiple experts in the way clinical studies or AI algorithm ground truth establishment might.

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 is a surgical suture, not an AI-powered diagnostic device or a system designed to assist human readers.

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

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

7. The type of ground truth used

The "ground truth" for this submission are the established international and national standards for surgical sutures and biocompatibility:

• United States Pharmacopeia (USP) requirements for Nonabsorbable Surgical Sutures (e.g., diameter, needle attachment, tensile strength).
• ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a physical device like a surgical suture. This is not an AI/machine learning device.

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

Not applicable, as there is no training set.

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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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TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.

Here's an analysis of the provided document regarding the acceptance criteria and study for the TRUSILK™ Non-absorbable Silk Surgical Suture:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for TRUSILK™ Natural Nonabsorbable Silk Surgical Suture relies on equivalence testing to predicate devices and adherence to United States Pharmacopeia (USP) specifications. The acceptance criteria essentially are to meet or exceed the performance specified by USP 26 for various characteristics, matching the predicate devices.

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

The document does not explicitly state the specific sample sizes used for testing each of the USP 26 criteria (e.g., how many sutures were tested for diameter, tensile strength, etc.). It only states that the testing was performed, and the device "meets or exceeds USP specifications."

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: The device is manufactured by Sutures India Pvt. Ltd. in Bangalore, India. The testing would have been conducted as part of their submission process, presumably at their facilities or a contracted lab. The data is retrospective in the sense that the tests were completed before the submission.

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

This type of information is not relevant or provided in a 510(k) submission for a surgical suture. The "ground truth" for the performance of a surgical suture is established by the well-defined, objective, and quantitative specifications set forth in recognized standards like the United States Pharmacopeia (USP). These standards outline the methods and acceptable ranges for physical and performance characteristics. Therefore, expert consensus in the clinical sense is not used to establish the "ground truth" for these measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by objective, measurable criteria defined in USP standards, not by human interpretation 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

Not applicable. This is a submission for a physical medical device (surgical suture), not an AI/software as a medical device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on USP 26 specifications for natural nonabsorbable silk surgical sutures. This includes:

• Defined ranges for diameter.
• Minimum requirements for tensile strength.
• Minimum requirements for needle attachment strength.
• Qualitative and quantitative criteria for extractable color and sterility.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "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.

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Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, §73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AESCULAP® Silkam® Nonabsorbable Silk Surgical Suture:

Key Takeaway: This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel acceptance criteria for a new device type and proving its performance through distinct studies with defined metrics like sensitivity, specificity, or reader improvement. The device is a conventional surgical suture, and its "performance" is largely defined by its adherence to established USP standards and its similarity to already approved sutures.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a conventional surgical suture demonstrating substantial equivalence, the "acceptance criteria" are intrinsically tied to meeting the requirements of existing U.S. Pharmacopeia (U.S.P.) standards and exhibiting physical properties comparable to predicate devices. The "reported device performance" is its successful demonstration of meeting these standards and equivalency.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of sutures or animal subjects used for the non-clinical tests. The testing performed was to demonstrate conformance to USP standards and substantial equivalence by comparing physical properties. The USP outlines testing methodologies, which inherently involve a statistically relevant number of samples for each parameter (e.g., diameter, tensile strength).
• Data Provenance: The studies were internal non-clinical tests ("Non-Clinical testing conducted on the subject device"). The mention of "in vivo biosafety studies, and 12 and 24 month implant studies in animals" indicates prospective animal studies were conducted. The country of origin of the data is implicitly the United States, as the submission is to the FDA for a US market.

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

• Number of Experts: Not applicable/not mentioned. This device is a physical product (suture) with well-defined physical and material properties measured quantitatively. "Ground truth" is established by adherence to established engineering, material science, and biological testing standards (e.g., USP monographs) rather than expert consensus on subjective interpretations.
• Qualifications of Experts: Not applicable/not mentioned. The assessment relies on laboratory measurements and analytical testing, not human expert interpretation for "ground truth" in the way it would for, for instance, a diagnostic imaging AI.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of an adjudication process, as the tests are for physical properties against defined standards, not subjective assessments requiring multiple experts for consensus.

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

• MRMC Study Done: No.
• Effect Size of Human Readers: Not applicable. An MRMC study is relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human-in-the-loop performance is assessed. This is a nonabsorbable surgical suture, a physical product, not an AI or interpretive device.

6. Standalone Performance Study

• Standalone Study Done: Yes, in essence. The non-clinical tests (e.g., physical testing for USP conformance, biosafety studies, implant studies) represent the "standalone" performance of the device itself (the suture material, its strength, biocompatibility) when tested against established benchmarks and compared to predicate devices. This is "algorithm only without human-in-the loop performance" in the context of the device's function as a physical object, not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily defined by standardized test methods and quantitative measurements outlined in the U.S. Pharmacopeia (U.S.P.) XXIII, combined with comparative data from predicate devices.
  • USP Monograph Requirements: For parameters like diameter, needle attachment, and tensile strength (e.g., , , ).
  • In Vitro and In Vivo Biosafety Data: Scientific data from biological studies.
  • Animal Implant Study Data: Data on tensile strength retention from animal studies.
  • Comparative Data: Performance metrics demonstrated by the legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. "Training set" is a concept specific to machine learning and AI development. This product is a physical medical device, not an AI system. The manufacturing process itself (from which "training" for humans might occur) is described as standard in the fiber industry, based on historical knowledge and established techniques, rather than iterative learning from a distinct "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI sense. The "ground truth" for suture manufacturing and quality control is established through decades of industrial practice, material science, and regulatory standards (like the USP). The manufacturing process itself is well-understood and governed by established quality assurance protocols to ensure consistency and meet specifications; it does not involve establishing "ground truth" in an AI/ML context.

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