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Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

• Acceptance Criteria (implied standards compliance):

  • Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
  • Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
  • Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
  • Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.

• Reported Device Performance (bench tests):

  • USP/EP diameter: Tested, found equivalent to predicate.
  • USP needle attachment: Tested, found equivalent to predicate.
  • USP tensile strength: Tested, found equivalent to predicate.
  • Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
  • Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

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SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.

Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document highlights the following non-clinical performance criteria and testing for the sutures:

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

2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.

4. Adjudication method for the test set: Not applicable as this is a non-AI/ML device.

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 as this is a non-AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.

7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).

8. The sample size for the training set: Not applicable as this is a non-AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.

The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the predicate devices.

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Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture. The device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Non-absorbable Surgical Silk Suture. This type of device is a physical medical product, not an AI/software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it applies to AI/software performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, etc.) is not applicable here.

Instead, for a physical medical device like a surgical suture, the "acceptance criteria" and "proof" relate to:

• Material properties: Does the suture material meet established standards (e.g., USP requirements for diameter, tensile strength)?
• Biocompatibility: Is the material safe for use in the human body (e.g., non-toxic, non-irritating, non-hemolytic)?
• Sterilization: Is the device effectively sterilized and free from harmful residuals?
• Packaging integrity: Is the packaging designed to maintain sterility until use?
• Performance: Does the device perform as intended (e.g., needle attachment strength)?

The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance.

Here's a breakdown of the relevant information from the document, reinterpreting "acceptance criteria" for a physical device:

Acceptance Criteria and Device Performance for Non-absorbable Surgical Silk Suture (K232355)

The acceptance criteria for this medical device are based on compliance with various established standards and the demonstration of substantial equivalence to a legally marketed predicate device (K161633, REXSIL). The performance is evidenced by non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The following sections (2-9) are not applicable as they relate to AI/software performance studies, which are not relevant for this physical surgical suture device. The information provided in the document confirms that this is a traditional medical device submission for which clinical trials (and thus clinical data for training/testing or expert adjudication for ground truth) were not required.

2. Sample size used for the test set and the data provenance: Not applicable for this physical device. Testing would involve a statistically significant number of physical samples for each test (e.g., tensile strength, diameter, biocompatibility). Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP) and laboratory measurements by qualified technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical device, not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is adherence to established engineering specifications, material standards, and biological safety standards (e.g., precise diameter measurements, specific tensile strength values, confirmed absence of cytotoxicity, etc.). These are objectively measured in laboratories according to validated test methods.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.

The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by §74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight.
The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

Here's a breakdown of the acceptance criteria and study information for the "Surgical Sutures with or without Needle" device based on the provided FDA 510(k) summary.

It's important to note that this document is a 510(k) summary for a medical device that demonstrates substantial equivalence to a predicate device, not necessarily a study proving clinical effectiveness or improvement with AI. The focus is on demonstrating that the new device is as safe and effective as devices already on the market. Therefore, many standard AI/ML study components (like multi-reader multi-case studies, ground truth establishment for a training set, the role of experts for ground truth, or effects of AI on human readers) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established standards for surgical sutures. The reported performance indicates compliance with these standards.

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

The document does not specify exact sample sizes for each non-clinical test. The testing was conducted to verify compliance with various established standards (USP, ISO, ASTM). The data provenance is generally "non-clinical tests" performed by the manufacturer in China (Huaian Seamen Medical Technology Co., LTD) to support the 510(k) submission. This is considered retrospective in the sense that the test results are being summarized for submission, not generated as part of a prospective clinical trial.

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

Not applicable. This is not a study involving diagnostic interpretation or machine learning where "ground truth" is established by experts in an interpretative capacity. The "ground truth" here is compliance with technical specifications and safety standards as measured by laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data where disagreements need to be resolved. The test results are objective measurements against defined 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

Not applicable. This document is for a physical surgical device (sutures), not an AI/ML-driven diagnostic or interpretative device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined acceptable parameters and thresholds within the cited standards (USP, ISO, ASTM). For example, the "ground truth" for suture diameter is the range specified in USP . For biocompatibility, the "ground truth" is the absence of adverse biological reactions as defined by ISO 10993 series. These are objective, measurable standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 30 in. length, swaged on a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

The System Includes:

(2) Suturing Device Pre-loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a ½ circle, 26 mm reverse cutting needle

The provided document describes the SafePath Suturing System, a medical device. Based on the content, the acceptance criteria and the study that proves the device meets those criteria are focused on physical properties and biocompatibility of the suture itself, rather than AI/algorithm performance. There is no mention of an AI component in this device.

Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, human-in-the-loop performance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details) is not applicable to this device.

Here's a breakdown of the acceptance criteria and study information that is applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to "Physical Testing" and "Biocompatibility Testing," but does not specify the sample sizes used for these tests.
The data provenance is implied to be laboratory testing of the device components, not human or patient data.

• Data Provenance: Laboratory testing of the SafePath Suturing System components (sutures and overall system).

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

Not applicable in the context of device physical and biocompatibility testing. Ground truth here refers to established scientific/engineering standards (USP and ISO).

4. Adjudication Method for the Test Set:

Not applicable. Testing appears to be based on adherence to quantitative standards rather than expert consensus on interpretations.

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

No, this type of study is for evaluating diagnostic or interpretive AI systems. The SafePath Suturing System is a physical medical device.

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

No, this pertains to AI/algorithm performance, which is not relevant to this device.

7. The Type of Ground Truth Used:

• Physical Testing: United States Pharmacopeia (USP) standards for Nonabsorbable Surgical Suture (Diameter, Needle Attachment, Tensile Strength).
• Biocompatibility Testing: FDA Guidance regarding the use of International Standards ISO-10993.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable, as there is no training set.

In summary, the SafePath Suturing System is a traditional medical device, and its acceptance criteria and testing focus on its physical properties, sterility, and biocompatibility in accordance with established medical device standards and regulations. The questions related to artificial intelligence and machine learning performance are not relevant to this specific device.

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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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Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular , ophthalmic and neurological procedures.
Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made of natural silk and a stainless steel needle. It is EO sterilized, and prygon-free. Nonabsorbable silk suture is braided.
The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical suture made of polypropylene and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyester suture with needle consist of a polyester surgical suture made of polyester and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyamide suture with needle consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is EO sterilized, and prygon-free.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a submission for a medical device (surgical sutures) seeking substantial equivalence to predicate devices, not reporting performance against specific acceptance criteria.

The information primarily focuses on:

• Manufacturer and Contact Information: Foosin Medical Supplies Inc., Ltd.
• Device Identification: Nonabsorbable Silk Suture with Needle, Nonabsorbable Polypropylene Suture with Needle, Nonabsorbable Polyester Suture with Needle, and Nonabsorbable Polyamide Suture with Needle.
• Device Description: Composition (natural silk, polypropylene, polyester, polyamide, stainless steel needle), sterilization method (EO sterilized), and braided/not braided.
• Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
• Predicate Devices: Citing K-numbers (K041514, K070243, K060165, K0060471).
• Substantial Equivalence Determination: A claim that the applicant devices are substantially equivalent to their respective predicate devices.
• FDA Correspondence: A letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.
• Indications for Use Forms: Standard FDA forms specifying the intended use for each suture type.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text, as it is not present in this document. Such information would typically be found in a separate section detailing performance testing (e.g., tensile strength, knot security, biocompatibility, sterility assurance level) within a more comprehensive regulatory submission.

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The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.

The Arrow Non-Absorbable Silk Suture has the following characteristics: Black, braided silk suture thread of '000' (Metric 2) diameter, 30" (75 cm) suture thread length, Pre-attached, straight, stainless steel needle, 2-3/8" (60 mm) needle length

The provided document is a 510(k) summary for a Non-Absorbable Silk Suture. This type of device approval primarily relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for a novel AI or diagnostic device. As such, many of the requested categories are not applicable or cannot be extracted from this specific document.

Here's an attempt to address the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, "performance tests" were conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device's performance is comparable to or "favorable" compared to the predicate devices in these tests.

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

The document does not specify the sample sizes for the tensile strength, needle attachment, suture diameter, or biocompatibility tests. It also does not mention what would typically be considered "test sets" in the context of AI or diagnostic device studies, nor does it refer to "data provenance" (country of origin, retrospective/prospective data). These are bench tests performed on the physical device.

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

This information is not applicable to a submission for a physical medical device like a suture, which relies on standardized bench testing and biocompatibility assessments, not expert-derived ground truth.

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

Not applicable. Bench tests do not involve expert adjudication in the same way as clinical or AI performance studies.

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 physical medical device, not an AI or diagnostic tool 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, not an algorithm.

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

For the performance tests, the "ground truth" is defined by the standards themselves (e.g., USP 29 and ISO 10993-1). The device's characteristics are measured against the specifications outlined in these standards and against the performance of predicate devices. For biocompatibility, it's about whether the material elicits an adverse biological response according to the ISO standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; there is no "training set."

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

Not applicable. There is no training set for this device.

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