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VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture.

VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field.

VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes.

PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes.

PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m.

PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.

Here's an analysis of the provided text regarding acceptance criteria and study information:

This document describes a 510(k) premarket notification for surgical sutures (VICRYL™, PDS™ II, and PDS™ Plus). It does NOT involve a device that utilizes AI or requires complex performance studies with acceptance criteria in the typical sense of a diagnostic or therapeutic AI medical device.

The document explicitly states: "The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence."

Therefore, a detailed breakdown of acceptance criteria and a study proving a device meets them (as would be expected for an AI/ML device) is not applicable here. The nature of this submission is to demonstrate substantial equivalence to previously cleared sutures, primarily based on identical functionality, technological characteristics, and intended use. The only change mentioned is to the labeling (Instructions for Use) for clarification, standardization, and harmonization.

However, if we try to interpret the "acceptance criteria" in the context of this specific 510(k) submission, it refers to the conditions that allow the FDA to determine the device is "substantially equivalent" to predicate devices. The "study" (or rather, the justification) for meeting these criteria is the comparison to the existing predicate devices.

Here's how we might frame the information based on the provided text, while acknowledging the limitations:

Acceptance Criteria and Justification of Substantial Equivalence for VICRYL™, PDS™ II, and PDS™ Plus Sutures

Given that this 510(k) submission is for surgical sutures and not an AI/ML diagnostic or therapeutic device, the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" differs significantly from what your detailed request implies. The core "acceptance criterion" for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" isn't a complex clinical trial with performance metrics but rather a comparison of technological characteristics, intended use, and materials.

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

2. Sample sized 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 context of evaluating performance data from a patient population or algorithmic output. The demonstration of substantial equivalence is based on the inherent design, composition, and manufacturing of the sutures, and a comparison of these attributes to predicate devices. No specific "sample size" of patients or data is mentioned for performance evaluation.

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. There is no "ground truth" establishment in the context of diagnostic accuracy for this type of medical device submission. The determination of substantial equivalence is made by the FDA's regulatory experts based on the manufacturer's submission and comparison to predicate devices, drawing upon established scientific and engineering principles for surgical sutures.

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

Not applicable. There is no "test set" or adjudication process of interpretations as would be found in a clinical study for a diagnostic 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. This device is not an AI-assisted diagnostic or therapeutic 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 algorithm.

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

Not applicable. As described, there is no "ground truth" in the diagnostic sense. The "truth" here is the established safety and effectiveness of the predicate devices, to which these new sutures are being compared for substantial equivalence in their fundamental characteristics.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML model.

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

Not applicable.

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Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.

Monosyn Quick is an absorbable flexible monofilament suture which is supplied sterile. It is composed of a synthetic polyglycolic acid-based copolymer. The Monosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 1. It is uncoated and will be available in a variety of cut lengths with or with out needles attached.

The provided text describes the regulatory filing for a medical device, the Monosyn Quick Synthetic Absorbable Surgical Suture, and outlines the testing performed to demonstrate its substantial equivalence to predicate devices. However, the document does not detail a study proving the device meets "acceptance criteria" in the way one might expect for a diagnostic or AI-driven system. Instead, it focuses on demonstrating compliance with recognized standards and substantial equivalence to existing devices for safety and performance.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission (510(k) for a surgical suture). I will answer the questions based on the closest available information in the document.

Here's a breakdown of the information that can be extracted:

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

The document doesn't explicitly state "acceptance criteria" as defined by specific thresholds for performance metrics. Instead, it refers to compliance with established USP standards for surgical sutures. The performance data is presented as satisfactory and demonstrating equivalence.

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

The document does not specify the sample sizes for the mechanical, biocompatibility, or resorption tests. It refers to "testing" and "data generation" but not specific numbers of samples. Data provenance is not mentioned beyond the tests being performed to support the 510(k) submission.

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

This concept is not applicable here. Surgical sutures are evaluated against engineering and biological standards, not through expert consensus on qualitative "ground truth" like in AI/diagnostic imaging.

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

Not applicable. This type of adjudication is used for establishing ground truth in human-AI studies, not for the evaluation of a physical medical device like a suture.

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-assisted diagnostic tool.

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

Not applicable. This is a surgical suture, not a standalone algorithm.

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

The "ground truth" equivalent in this context is the adherence to established industry standards and regulations:

• USP (United States Pharmacopeia) 39 Monograph for Absorbable Surgical Sutures: Provides specifications for material, diameter, tensile strength, and other physical properties.
• ISO (International Organization for Standardization) 10993 series and 11135-1: Provide standards for biological evaluation (biocompatibility) and sterilization processes for medical devices.
• Predicate Device Performance: Comparison to existing legally marketed devices serves as a benchmark for safety and effectiveness.

8. The sample size for the training set

Not applicable. Medical devices like sutures are not "trained" in the machine learning sense. The manufacturing process is established and controlled, but there isn't a "training set" of data in the way an AI model would have one.

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

Not applicable. As noted above, this device does not utilize machine learning or require a training set with established ground truth in that context.

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Quill™ Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable suture available in various suture lengths and needle configurations in USP Sizes 3-0 and 4-0. Each suture has bi-directional barbs along the long axis of the suture strand. Barbs allow for tissue approximation without the need to tie surgical knots.

Quill™ SRS is comprised of dyed (D&C Violet No. 2 per 21 CFR 74.3602) polyester [poly (p-dioxanone)], the empirical molecular formula of which is (C4H6O3)x. Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.

The provided document is a 510(k) premarket notification for a medical device (Quill™ Self-Retaining System (SRS) comprised of PDO, a surgical suture). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, high-risk device might.

The document does not include information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the context of AI/ML or a novel technology requiring extensive clinical trials with statistical endpoints. Instead, it relies on demonstrating equivalence to existing, approved devices.

Therefore, I cannot directly extract most of the requested information, which pertains to a different type of device evaluation study (e.g., AI/MRMC study, standalone performance, ground truth establishment, training set size).

However, I can provide the limited information available from the document:

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

The document does not specify "acceptance criteria" in a quantitative, statistical sense for this device. Instead, it argues for "substantial equivalence" based on qualitative comparisons and an animal study. The "performance" is implicitly deemed equivalent to the predicate devices.

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

The document mentions "animal studies" to assess the capabilities of the barbs.

• Sample Size: Not specified.
• Data Provenance: "Animal studies." No country of origin or retrospective/prospective nature is specified, but animal studies are typically prospective.

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. The document describes animal studies, not human-read diagnostic studies involving experts for ground truth.

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

Not applicable. This type of adjudication pertains to human expert interpretation of data, which is not described.

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 not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML algorithm.

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

For the animal studies, the "ground truth" would be the observed wound approximation over time, likely assessed directly by the researchers or veterinary professionals involved in the study.

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.

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The Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat ® Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neurological surgery uses.

Atramat ® Monofilament Polydioxanone are synthetic absorbable sterile surgical sutures composed of poly (p-dioxanone) synthetic polymer. These products are offered as monofilament or and it is offered uncoated or coated, it could also be undyed or dyed with D&C Violet No. 2.

The Atramat® Synthetic Absorbable Polydioxanone Surgical Suture is substantially equivalent to the Ethicon PDS II® Polydioxanone Synthetic Absorbable Polydioxanone Surgical Sutures. The substantial equivalence was proven by non-clinical testing.

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of sutures. The testing involved comparing the Atramat® PDO sutures directly against the requirements of USP 26 for absorbable surgical sutures.
• Data Provenance: Not applicable in a traditional sense of patient data. The tests were non-clinical, likely laboratory-based, and performed on the subject devices themselves. Country of origin for the data is not specified, but the submitter is based in Mexico.

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 this non-clinical study was established by the universally recognized standards set forth in USP 26 (United States Pharmacopoeia). These are objective, published standards, not subjective expert consensus on individual cases.

4. Adjudication method for the test set:

• Not applicable. The determination of conformance to USP 26 standards is objective, based on laboratory measurements and comparison to defined physical and chemical criteria. No adjudication method involving human experts interpreting results was required.

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

• No. This was a non-clinical study for a surgical suture, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are not relevant.

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

• No. This device is a surgical suture, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used:

• Standard-based Ground Truth: The ground truth for the non-clinical tests was established by the performance requirements and specifications detailed in the United States Pharmacopoeia (USP) 26 for absorbable surgical sutures.

8. The sample size for the training set:

• Not applicable. This was a non-clinical evaluation of a physical medical device against established standards, not a machine learning model requiring a training set.

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

• Not applicable, as there was no training set for a machine learning model.

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Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.

The subject device is an absorbable, flexible multifilament suture thread which is supplied sterile. It is composed of a synthetic polyglycolic acid polymer and it is indicated for soft tissue approximation where only short term wound support is required. It will be offered dyed or undyed with the FDA approved colorant D&C Violet No.2 or D&C Green No.6 in accordance with Title 21 CFR, §74.3206. The modified device is coated with an absorbable polyclyconate.

The provided document is a 510(k) summary for the Safil and Safil Quick Synthetic Absorbable Surgical Suture. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a detailed clinical study in the way AI/ML devices often do.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML context. Instead, it focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The device is a surgical suture, a physical medical device. The concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "standalone performance" are typically applied to AI/ML software or diagnostic devices that generate a result based on data analysis.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating "substantial equivalence" to existing legally marketed devices. This usually involves:
  • Comparing technological characteristics (materials, design, intended use).
  • Bench testing to ensure physical properties (e.g., tensile strength, absorption profile) are comparable.
  • Sometimes, biocompatibility testing.
    It generally does not involve clinical studies with the kind of structured "acceptance criteria" and "ground truth" assessment seen for AI/ML algorithms.
• Absence of Data: The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This reinforces that there aren't formal, quantitative acceptance criteria for clinical performance that the manufacturer needs to meet and prove through a study for this specific device type and regulatory pathway.
• Focus on Predicate Devices: The "Performance Data" section simply states that no performance standards exist, and the "Substantial Equivalence" section lists predicate devices. This implies that the 'proof' of safety and effectiveness comes from its similarity to devices already on the market, rather than a novel study demonstrating adherence to new performance metrics.

In summary, the provided text describes a medical device (surgical suture) pursuing a 510(k) clearance based on substantial equivalence, which does not involve the detailed performance study and acceptance criteria typically associated with AI/ML devices.

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Monodek™ 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 opthalmic 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.

Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and is provided in a variety of lengths, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.

The provided text describes a 510(k) summary for the Monodek™ Synthetic Absorbable Surgical Suture, which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance (beyond meeting USP requirements for sutures except for oversized diameter)
• Sample sizes for a test set or data provenance for such a test
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth for a test set
• Sample size for a training set
• How ground truth for a training set was established

The information provided focuses on regulatory equivalence:

Acceptance Criteria for Substantial Equivalence:

The primary "acceptance criteria" for the device, as presented, are based on demonstrating substantial equivalence to predicate devices and conformance with established standards and guidance documents. These implicitly act as the performance benchmarks.

Study Proving Acceptance Criteria:

The "study" used to demonstrate that the device meets these acceptance criteria is a regulatory submission based on comparison to predicate devices and adherence to established standards.

• Study Type: This is not a clinical trial or a performance study in the typical sense of a novel device proving its efficacy or accuracy against specific clinical endpoints. Instead, it is a 510(k) premarket notification demonstrating substantial equivalence to legally marketed predicate devices.
• Methodology: The determination of substantial equivalence was based on:
  • A detailed device description.
  • Performance testing (implied by meeting USP requirements, though specific test results or protocols are not detailed in this summary).
  • Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, USP Section XXV).
  • Adherence to FDA guidance documents ("Guidance for Surgical Suture 510(k)s" and "Class II Special Controls Guidance Document: Surgical Sutures").

Missing Information (as per your requested categories):

The document does not describe any specific studies that would involve:

• Sample sizes for a test set (as there wasn't a separate "test set" in the context of an AI device)
• Data provenance
• Number of experts or their qualifications for ground truth in a performance study
• Adjudication method
• MRMC comparative effectiveness study or effect size (as this is a physical medical device, not an AI diagnostic tool)
• Standalone performance (not applicable for this type of device)
• Type of ground truth (e.g., pathology, outcomes data) for a diagnostic performance study
• Sample size for a training set
• How ground truth for a training set was established

In summary, for this specific medical device (a surgical suture), the "acceptance criteria" are met by demonstrating broad equivalence to existing, approved products and adherence to industry standards and regulations, rather than through a performance study that measures accuracy or efficacy against a defined ground truth in a test and training set, which would be typical for AI/diagnostic devices.

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Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.

This document describes the marketing authorization for the BONDEK® PLUS Synthetic Absorbable Surgical Suture. It is a 510(k) Summary of Substantial Equivalence, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device.

Key takeaway: This device is a surgical suture, and the acceptance criteria and supporting studies will revolve around its physical properties, biocompatibility, and performance in comparison to existing sutures, rather than accuracy metrics for a diagnostic device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing "acceptance criteria" and "reported device performance" in the context of typical diagnostic or AI device studies (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this surgical suture is based on its similarity in intended use, materials, design, and performance characteristics to predicate devices, and conformance with voluntary performance standards.

Therefore, the "acceptance criteria" are implied to be meeting the requirements of these standards and being comparable to the predicate devices. The "reported device performance" refers to the demonstration of this conformance and comparability.

• Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending))
• Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198)
• Lukens Medical Corp. Lukens® PGA suture (#K965162) |

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

The provided document does not mention a specific "test set" in the way one would for diagnostic device studies involving data samples. The evaluation of a surgical suture primarily involves bench testing (to meet physical standards) and biocompatibility testing (often in vitro and in vivo animal studies, or reliance on established material safety).

• Sample Size: Not specified in terms of clinical or data samples. The "data" here refers to the results of bench and biocompatibility testing required by the aforementioned standards.
• Data Provenance: Not specified. This would typically be from laboratory testing conducted by the manufacturer or accredited labs, and potentially animal studies for biocompatibility, rather than human patient data.

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

This type of information is not applicable to this 510(k) submission for a surgical suture. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret medical images or data. For a physical device like a suture, the "ground truth" is established by adherence to recognized engineering, material science, and biological standards through objective testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods are used in studies where multiple human readers or algorithms provide interpretations that need to be reconciled for a definitive "ground truth." This is not how a surgical suture's performance or equivalence is evaluated. Its performance is measured against objective standards.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for diagnostic AI devices, not for a synthetic absorbable surgical suture.

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

This is not applicable. This question pertains to AI algorithms, which are not part of this medical device (a surgical suture).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this surgical suture, the "ground truth" is defined by:

• Voluntary Performance Standards: Such as ISO 10993-1 (biocompatibility) and U.S.P. Section 1475 (physical properties of sutures).
• Material Science and Engineering Principles: Ensuring the suture material meets specifications for strength, degradation, and handling characteristics.
• Comparability to Predicate Devices: Demonstrating that the new device performs equivalently to existing, legally marketed sutures based on their established performance profiles.

There is no "expert consensus" or "pathology" in the typical sense for establishing performance of the suture itself, although expert surgeons would evaluate its handling characteristics in practice. Outcomes data might be collected in a larger clinical trial for novel claims, but for a 510(k) for a well-understood device type, it's primarily bench and biocompatibility data.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical surgical suture, not an AI or software device.

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

This is not applicable for the same reasons as point 8.

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Bondek Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.

This document is a 510(k) summary for the Bondek® Synthetic Absorbable Surgical Suture. It establishes substantial equivalence to previously marketed devices and outlines the indications for use and device description. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in submissions for devices that involve diagnostic or AI components, where performance is measured against a ground truth. For sutures, the "performance" is generally related to material properties, biological compatibility, and mechanical strength, which are assessed through conformance to standards (e.g., USP, ISO 10993-1) as mentioned in the document. The document states:

"The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"."

This indicates that the "acceptance criteria" were compliance with these established standards, and the "study" was the performance testing conducted to demonstrate this compliance. However, the specific data from these tests is not provided in this summary.

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