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Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.

This document is a 510(k) summary for a medical device called "Force Fiber® Suture - Black." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study where specific performance criteria are measured against acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the general acceptance criteria and what is reported about the device's performance based on the provided text.

Acceptance Criteria and Reported Device Performance

• Suture diameter
• Tensile strength
• Needle attachment | "Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter."
  "Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003." |
  | Material Biocompatibility (ISO 10993-1:2018) | Evaluation through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. This implies meeting the safety requirements for medical devices in contact with the body. | "All materials used in the fabrication of the Force Fiber Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." |
  | MRI Safety | "MR Safe" designation, meaning it poses no known hazards in MR environments. | "Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments." |
  | Substantial Equivalence | No differences in technological characteristics and performance characteristics compared to predicate devices, and the difference (addition of black dye) does not raise new questions of safety or efficacy, making it as safe and effective as currently marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) pathway. | "Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices. The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye... This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices." |

Information Not Available in the Document:

Because this document is a 510(k) summary demonstrating substantial equivalence for a surgical suture, not a clinical study report for an AI/imaging device, the following information is not provided:

2. Sample size used for the test set and the data provenance: Not applicable in this context. The testing mentioned refers to material properties and biocompatibility, not performance against a specific "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI algorithms (e.g., diagnostic accuracy) is not relevant here.
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 device is a surgical suture, not an AI-assisted diagnostic tool.
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 material properties, the "ground truth" would be established by validated testing methods and specifications (e.g., USP standards), not expert consensus on medical images or outcomes.
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.

In summary, the provided document describes a medical device (surgical suture) and demonstrates its compliance with established regulatory standards (USP, ISO) and substantial equivalence to existing predicate devices. It does not involve AI or imaging diagnostics, and therefore, many of the requested data points related to those types of studies are not relevant or present.

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Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in and neurological procedures.

Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available as braided undyed (white), braided blue, co-braid of white UHMWPE and blue polypropylene (PP) monofilament strands, co-braid of white UHMWPE fibers and black Nylon monofilament strands, and co-braid of white UHMWPE fibers and green polyester (PET) fibers.

Force Fiber OthoTape Suture is an uncoated braid that is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid.

Bondek and Bondek Plus Suture is an absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The Bondek suture material is coated with polycaprolactone-glycerol monostearate solution, and is available in green and beige (undyed) USP sizes 8-0 through 2. The Bondek Plus suture material is coated with polycaprolactone-co-polygolycolic acid, and is available in violet, green or beige (undyed) USP sized 6-0 through2.

Monodek Absorbable Surgical Suture is a monofilament suture that meets all USP requirements except for oversize diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture may be supplied on ligating reels.

Polyglytone* 6211 suture, U.S.P size 2-0, is available, undyed (natural). The suture is monofilament, and may be provided with or without plegets.

The Teleflex surgical sutures are provided sterile (EO), for singe use only and may be provided in a variety of cut lengths with or without needles. A variety of attached needles are available from either 300 or 400 series stainless steel.

The provided text is a 510(k) Summary of Safety and Effectiveness for Teleflex Surgical Sutures. It details various types of sutures (Force Fiber, Bondek, Monodek, Polyglytone) and their characteristics, indications for use, and a comparison to predicate devices for substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of performance metrics for an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to previously cleared surgical sutures, primarily through similar technological characteristics and performance rather than a specific set of acceptance criteria and a study to meet them.

The only "testing" mentioned is non-clinical testing to demonstrate an "MR Safe" claim, which is a safety characteristic, not a performance metric in the traditional sense of AI/ML or diagnostic device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not present in the provided text. The document describes a traditional medical device (sutures) approval process, not an AI/ML or diagnostic device.

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Force Fiber Fusion™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Force Fiber Fusion suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. The tape section(s) are flat in shape and differ from USP requirements. The round section(s) exceed USP for diameter. The suture meets USP tensile strength requirements and USP needle attachment requirements. Force Fiber Fusion suture is available in sizes 1 through 5 and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), UHMWPE/blue polyester co-braid, UHMWPE/black Nylon co-braid or UHMWPE/green Polyester co-braid.

This document is a 510(k) Summary of Safety and Effectiveness for the Teleflex Force Fiber Fusion™ Suture. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this submission does not describe a study involving an AI/ML device or its acceptance criteria. Therefore, I cannot provide the requested information.

The document discusses a surgical suture, which is a medical device, but it is not an AI/ML device. The submission is focused on demonstrating the substantial equivalence of a new suture design to existing, legally marketed predicate sutures through standard material and mechanical testing, not through performance metrics of an algorithm.

Thus, key sections of the requested output, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information, are not applicable to the content provided.

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Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Force Fiber OrthoTape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

The provided document is a 510(k) premarket notification for the Teleflex Force Fiber® OrthoTape™ Suture. It establishes substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses an AI/ML-based device, human readers, or a ground truth involving pathology or outcomes data. Therefore, many of the requested sections about AI/ML device performance and clinical study details cannot be answered based on the provided text.

However, I can extract information related to the device's performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set (number of sutures or needles tested) for tensile strength and needle attachment. The testing was conducted in accordance with USP (United States Pharmacopeia) requirements, implying these are standard in vitro mechanical tests rather than clinical studies with patient data. Therefore, there is no country of origin for "data" in the context of patient data, nor is it retrospective or prospective.

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

Not applicable. The ground truth for tensile strength and needle attachment is based on objective, standardized physical measurements against USP specifications, not expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. The "test set" refers to physical samples of the suture undergoing mechanical testing against defined specifications. There is no human adjudication involved in these objective measurements.

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/ML-based diagnostic or assistive device that would involve human readers or MRMC studies.

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 device's performance is based on objective physical and mechanical specifications outlined in the United States Pharmacopeia (USP) for non-absorbable surgical sutures, specifically for tensile strength and needle attachment. Additionally, biological qualification safety tests (AAMI ANSI ISO 10993-1: 2009/(R) 2013) were conducted on the materials.

8. The sample size for the training set

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

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment in that context.

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The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

• Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Foot/Ankle: Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
• Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Ulnar Collateral Ligament Scapholunate Ligament Reconstruction, Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
• Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating.

The provided text describes a 510(k) submission for a medical device, the Porous Morphix® Suture Anchor with Force Fiber® Suture. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202) based on:

• Same Intended Uses: The new device has the same indications for use as the predicate.
• Equivalent Technological Characteristics: Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports this equivalence.
• Minor Differences: The differences are an extruded porous layer on the top surface of the device and a change in suture supplier. These differences were determined not to raise questions concerning safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These points are relevant to AI/ML device validation, which is a different regulatory pathway and type of study than what is presented in this 510(k) summary for a physical medical device (suture anchor).

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Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

Force Fiber® Green Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture

The provided document is an FDA 510(k) clearance letter for the "Force Fiber® Green Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture." This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI-driven medical devices.

Instead, it's a regulatory letter confirming that the device is substantially equivalent to a predicate device, as required for traditional medical devices like sutures. The criteria discussed in the letter are related to regulatory compliance (e.g., registration, listing, manufacturing practices, labeling) and not performance metrics as would be expected for an AI/ML device.

Therefore, I cannot fulfill your request using the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.

The provided document is a 510(k) Pre-Market Notification for a surgical suture, not a submission for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods typically associated with studies for AI/ML devices. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing in accordance with regulatory standards for surgical sutures.

Therefore, I cannot provide the requested information based on the given text.

If you have a document pertaining to an AI/ML device, I would be happy to analyze it for the details you've outlined.

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Force Fiber® Black Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Black Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 5-0 through 5, meeting USP requirements except for oversized diameter.

The provided document is a 510(k) summary for a surgical suture and does not describe acceptance criteria, performance studies, or ground truth establishment for an AI/ML powered medical device. Therefore, I cannot extract the requested information from this document.

The document pertains to a physical medical device (suture) and discusses its substantial equivalence based on:

1. Detailed device description: Composition (UHMWPE for Force Fiber Black Co-Braid Polyethylene), availability in sizes 5-0 through 5, and meeting USP requirements except for oversized diameter.
2. Performance testing: All sizes tested according to USP 30 for Knot Pull Tensile Strength, Needle Attachment, and Diameter, meeting the Class II Special Controls Guidance for Surgical Sutures (June 3, 2003).
3. Conformance with voluntary performance standards: ISO 10993-1:2003 for biological qualification safety tests of materials.

The review of the provided text confirms that it is a 510(k) submission for a non-AI/ML surgical suture. Therefore, the requested information regarding AI/ML device acceptance criteria, study details, and ground truth establishment is not present.

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Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.

The provided text describes a 510(k) PreMarket Notification for the Force Fiber® Polyethylene Non-Absorbable Surgical Suture. It details the device, its intended use, and substantial equivalence to predicate devices, along with a summary of testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested." This implies that every available size (from 5-0 through 5) was included in the testing, but a specific numerical sample size for each test (e.g., number of sutures per size tested for tensile strength) is not provided.
• Data Provenance: The standard tests (USP 30, Class II Special Controls Guidance, ISO 10993 Part 1) are internationally recognized standards. The country of origin for the data generated from these tests is not explicitly stated, but it is implied to be from testing conducted by Teleflex Medical or accredited labs as part of their submission to the FDA in the USA. The testing is implicitly prospective, as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

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

This information is not provided in the text. The ground truth for this type of device is established by adherence to recognized testing standards rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods like "2+1, 3+1" are typically used for studies involving human interpretation (e.g., image reading), not for physical performance tests of surgical sutures against objective standards. The "adjudication" is essentially handled by the objective pass/fail criteria defined within the USP and ISO standards.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and therefore not provided. The device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided. The device is a physical medical device (suture), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective, quantitative measurements defined by established performance standards and guidance documents. Specifically:

• Knot Pull Tensile Strength: Based on USP 30 requirements.
• Needle Attachment: Based on USP 30 requirements.
• Diameter: Based on USP 30 requirements (with the noted exception for oversized diameter).
• Biocompatibility: Based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices" for safety.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not an AI/ML device that requires a "training set." The product is a manufactured physical device, and its performance is evaluated against established physical and biological standards.

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

This information is not applicable and therefore not provided, as there is no "training set" for a surgical suture.

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Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.

The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.

This document is a 510(k) premarket notification for a surgical suture. It demonstrates substantial equivalence to a predicate device rather than providing a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information from the provided text.

Here's an analysis based on the provided document:

Acceptance Criteria and Study Details (Not Applicable for this Submission Type)

Since this is a 510(k) submission for a surgical suture establishing substantial equivalence, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically applied to diagnostic AI algorithms (e.g., sensitivity, specificity thresholds) does not directly apply. Instead, the submission focuses on demonstrating that the new device (Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture) is as safe and effective as a legally marketed predicate device (Force Fiber Polyethylene Non-Absorbable Surgical Suture).

The evaluation is based on technological characteristics and their equivalence to the predicate, along with meeting general regulatory requirements (USP for suture sizes, general controls).

The document states: "The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness." This is the core "proof" of equivalence for this type of device, rather than a clinical performance study with statistical metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the context of diagnostic AI acceptance criteria. The "acceptance" for this device is based on demonstrating substantial equivalence to a predicate by meeting (or being equivalent to) its technological characteristics and regulatory standards.

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

Not applicable. This submission does not involve a "test set" in the sense of a dataset for an algorithm. It's a review of device design and specifications against a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert ground truth establishment for a test set was performed or documented in this submission.

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

Not applicable. No adjudication method for a test set was performed or documented.

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 diagnostic tool.

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 AI algorithm.

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

Not applicable. For this type of device, "ground truth" relates to material properties, manufacturing specifications, and biological compatibility, which are assessed through standard engineering and biocompatibility testing, not through expert consensus on diagnostic images or pathology. The document doesn't detail specific testing.

8. The sample size for the training set

Not applicable. No training set for an algorithm is involved.

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

Not applicable. No training set for an algorithm is involved.

In summary: The provided document is a 510(k) summary for a medical device (surgical suture). It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting a performance study against specific acceptance criteria for a diagnostic algorithm.

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