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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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The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.

The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:

• Centerscope Magnetic Injection Port Finder .
• Winged Infusion Set .

The provided text describes the 510(k) premarket notification for the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's clinical performance. As such, information regarding acceptance criteria for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, or multi-reader multi-case studies is not applicable to this document.

The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by biocompatibility and mechanical testing.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related)

The document mentions acceptance criteria related to mechanical testing, but the specific numerical criteria are not detailed. It only states that the results met the pre-determined acceptance criteria.

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

Not applicable. This is not a study involving a "test set" of data in the context of an AI/algorithm. The device underwent physical and material testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm.

4. Adjudication Method

Not applicable.

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

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI/algorithm.

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

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

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The device (MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander) demonstrates that it meets acceptance criteria through:

• Biocompatibility Testing: The device utilizes materials identical to a previously cleared predicate device for permanent tissue contact. This indicates that the materials have already met biocompatibility standards and no new testing was required.
• Mechanical Testing: Specific mechanical tests were conducted in accordance with ASTM F1441-03, "Standard Specification for Soft-Tissue Expanders." These tests evaluated parameters such as overexpansion and bladder leak. The document states that all results met pre-determined acceptance criteria, thus demonstrating substantial equivalence to the predicate device. The changes specifically addressed in this testing were the change to a smooth surface and the addition of three suture tabs, which impacted the connection of external components (Base and Injection Dome) to the shell surface.

The "study" described is primarily a series of engineering and materials tests demonstrating that the modified physical device (with a smooth surface and additional suture tabs) maintains the same safety and performance characteristics as its predicate devices, especially regarding its physical integrity and material compatibility.

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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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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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REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

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 the exact sample sizes for each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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 is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

REXSIL (Nonabsorbable Silk Suture)

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 the exact sample sizes for each individual test conducted. It only states that "REXSIL were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing. No information on country of origin for the data is provided.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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 is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXSIL is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

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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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Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.

The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:

• Intended use
• Material
• Design
• Performance (Diameter, Needle attachment, and Tensile strength)
• Sterilization method
• Biocompatibility evaluation

The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.

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