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

GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.

This document is a 510(k) summary for the GalaSTITCH Absorbable Monofilament Suture. It states that the device is identical to a previously cleared predicate device, TephaFLEX Absorbable Monofilament Suture (K082178), in terms of materials, design, and manufacturing processes. The submission is a "Special 510(k)" primarily for rebranding and a minor clarification to a contraindication statement in the labeling.

Therefore, the information requested regarding acceptance criteria and study data to prove device performance is not present in this document because no new testing was performed for this 510(k) submission.

The document explicitly states:
"There have been no changes to the P4HB material, design specifications, or the manufacturing processes for purposes of this submission. The GalaSTITCH suture is identical to the TephaFLEX predicate; therefore, no additional testing was necessary to demonstrate safety and performance."

This means that the safety and performance of the GalaSTITCH suture are based on its equivalence to the predicate device, TephaFLEX, for which testing would have been performed and documented in its original K082178 510(k) submission.

In summary, none of the requested information (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or training set ground truth establishment) can be extracted from this specific document.

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TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

TephaFLEX suture is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB). The suture consists of an inner core of multifilament fibers covered by a braided sheath made of multifilament fibers. The suture is provided dyed (D&C Violet No. 2) or un-dyed and is offered in a variety of cut lengths, with or without needles attached.

The provided document describes the acceptance criteria and the study that proves the TephaFLEX Braided Suture meets these criteria. Since this is a medical device (suture) and not an AI/ML device, many of the requested fields (e.g., sample size for training set, number of experts, MRMC studies, standalone performance) are not applicable.

Here's the information extracted from the document:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size:
     • Biocompatibility: Not explicitly stated as "sample size" but involved "12, 26, 52 and 78 week Subcutaneous Implantation studies in rabbits." This implies a cohort of rabbits used over these time points.
     • In vivo implantation for strength/mass loss: Conducted in "rabbits." The exact number of rabbits is not specified in the provided text.
     • Physical/Mechanical testing: Not specified, but generally follows standardized testing procedures for medical devices.
   • Data Provenance: The studies were conducted by Tepha, Inc. and are retrospective in nature, as they involve testing of a manufactured device. The origin of the animal subjects (rabbits) is not specified but is assumed to be within a controlled lab environment.

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

   • Not Applicable. This is a medical device (suture) and the assessment criteria are based on standardized physical, mechanical, chemical, and biological tests, rather than expert interpretation of images or clinical data. The "ground truth" is defined by compliance with USP and ISO standards and observed biological responses.

3. Adjudication method for the test set:

   • Not Applicable. As the assessment is based on objective laboratory and in vivo testing against established standards, an adjudication method for conflicting expert opinions is not relevant.

4. 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 medical device, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

   • Not Applicable. There is no algorithm involved; this is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing and Standards Compliance: The ground truth is established by meeting predefined threshold values for physical and mechanical properties as outlined in USP 33 ( Suture Diameter, Knot Pull Tensile Strength, and Needle Attachment Strength) and demonstrating non-toxic responses and equivalent in vivo performance according to ISO-10993 for biocompatibility studies and in vivo strength retention studies.

7. The sample size for the training set:

   • Not Applicable. This is a medical device for which "training set" is not a relevant concept. The device's characteristics are inherent to its design and manufacturing process, not learned from a dataset.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Tornier, Inc. Phantom Fiber BioFiber Suture is a n absorbable, braided, sterile, surgical USP size 2 suture composed of poly(4-hydrobutyrate) (P4HB) with cyanoacrylate adhesive tipped ends. Phantom Fiber BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.

Here's a breakdown of the acceptance criteria and study information for the Tornier, Inc. Phantom Fiber BioFiber Suture (K130422), based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Tornier BioFiber Suture K122487) through non-clinical testing. It does not describe an AI/ML-based device or associated clinical studies with human readers. Therefore, several requested sections are not applicable in this context.

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

• Sample Size: The document does not specify the exact sample sizes for the USP-compliant tests or the non-USP tests (in-vivo degradation, residual molecular weight).
• Data Provenance: Not specified. The testing appears to be laboratory-based (non-clinical).
• Retrospective/Prospective: Not applicable as it's non-clinical, non-human testing.

2. 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 "ground truth" for the performance tests (e.g., tensile strength, diameter) would be the established USP standards themselves, measured by laboratory equipment, not by human experts.

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

• Not applicable. Adjudication methods are typically relevant for human-interpretable data (e.g., medical images) where there might be disagreement among reviewers. For physical performance tests, the measurements are objective.

4. 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.

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

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

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

• The ground truth for the performance tests appears to be objective measurements against established industry standards (United States Pharmacopeia - USP). For the non-USP tests, "in-vivo degradation testing of product strength over time and residual molecular weight" would use laboratory measurements.

7. The sample size for the training set

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

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

• Not applicable. This device is a physical medical device.

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

Tornier, Inc. BioFiber Suture is an absorbable, braided, sterile, surgical suture composed of poly(4-hydrobutyrate) (P4HB). BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.

This document describes the 510(k) summary for the Tornier BioFiber Suture (K122487). It focuses on demonstrating substantial equivalence to a predicate device, TephaFLEX™ Poly(4-hydroxybutyrate) Suture, rather than presenting a study to prove the device meets pre-defined acceptance criteria in the manner of a clinical trial for diagnostic devices. Therefore, many of the typical acceptance criteria and study design elements you asked for are not directly applicable or available in this type of submission.

Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations of this type of regulatory submission:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the USP (United States Pharmacopeia) standards for absorbable surgical sutures and ISO 10993-1 for biocompatibility. The performance is reported as compliance with these standards.

Note on "Slightly Larger Diameter": This deviation from the predicate's exact specification for USP size 2 diameter is noted but must have been deemed acceptable by the FDA for the device to achieve substantial equivalence. The overall USP compliance for "Size 2" likely means it falls within the permitted range despite being on the larger side of that range.

Study Details

This submission describes non-clinical testing to support substantial equivalence, not a clinical study on human subjects with a diagnostic device. Therefore, questions 2-6 and 8-9 are not directly applicable in the way they would be for a clinical trial of a diagnostic algorithm.

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

• Sample Size: Not explicitly stated. For mechanical and material testing, sample sizes would typically be determined by statistical requirements for engineering tests, but these are not provided in this summary.
• Data Provenance: The testing was "performed in accordance with FDA's Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology." The tests are laboratory-based (mechanical, chemical, biological compatibility), not patient data-based.

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 not a diagnostic device involving expert interpretation of data. The "ground truth" here is compliance with established engineering and biocompatibility standards measured through standardized laboratory tests.

4. Adjudication method for the test set:

• Not applicable. Results are quantitative measurements against objective standards, not subjective interpretations requiring adjudication.

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

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

7. The type of ground truth used:

• The "ground truth" consists of established, objective engineering standards (e.g., USP for diameter, for needle attachment, for tensile strength) and biocompatibility standards (ISO 10993-1). These are quantitative benchmarks against which the device's performance is measured.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. This is not an AI/machine learning device.

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MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The MonoMax sutures will be offered in sizes 2, 1, 0, 2-0, 3-0, 4-0, and 5-0. The sutures will be available in a variety of cut lengths with or without needles attached. The sutures will be available undyed, and dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, 74.3602.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size for the test set used in this specific submission (K100876).

However, it states: "Please reference K082178 for performance data, which were collected by Tepha, Inc. for the predicate device, that were used to support the substantial equivalence of the MonoMax suture device." This indicates that the performance criteria were met by relying on data from a predicate device (TephaFLEX® Absorbable Suture, K082178/K081099/K052225).

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: The performance data was collected by Tepha, Inc. for the predicate device. The country of origin and retrospective/prospective nature of that data are not mentioned in this document.

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

This document describes a medical device (suture) and its performance is evaluated against technical specifications (USP 28, ISO 10993-1, animal testing for resorption profile), not against a 'ground truth' established by medical experts in the way that, for example, an AI diagnostic tool would be. Therefore, this information is not applicable to this type of device and study.

4. Adjudication Method for the Test Set

As mentioned above, this study evaluates technical specifications of a physical device. There is no mention of an adjudication method as it would apply to expert review of a "test set" in the context of diagnostic or interpretive tasks. The "adjudication" is essentially the determination of whether the device meets the predefined technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is focused on demonstrating the technical performance of a medical device (suture) against established standards, not on evaluating human reader performance with or without AI assistance.

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

No, this refers to a physical medical device (suture), not an algorithm or AI. Therefore, the concept of "standalone performance" in the context of AI is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry and regulatory standards:

• USP 28 (United States Pharmacopeia) for mechanical testing.
• ISO 10993-1 (International Organization for Standardization) for biocompatibility.
• Animal testing for the resorption profile.

The "ground truth" is whether the device's physical and biological properties meet these pre-defined, quantitative standards.

8. The Sample Size for the Training Set

This document describes a performance evaluation of a physical medical device (suture) against predefined specifications, not an AI model. Therefore, the concept of a "training set" does not apply.

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

As stated above, the concept of a "training set" is not applicable here. The ground truth for this device's performance is the adherence to established technical standards.

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TephaFLEX absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

TephaFLEX sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The TephaFLEX sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

Here's an analysis of the provided text regarding the TephaFLEX Absorbable Suture, addressing your requested information:

Analysis of Acceptance Criteria and Study for TephaFLEX® Absorbable Suture (K082178)

This document describes a 510(k) submission for a medical device (TephaFLEX® Absorbable Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through a clinical trial with specific acceptance criteria in the context of AI/diagnostic devices. Therefore, many of your requested points regarding AI device studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an absorbable surgical suture), the "acceptance criteria" are typically defined by recognized standards and benchmarks for physical properties and biocompatibility. The "reported device performance" refers to the results of testing against these standards.

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

• Sample Size: The document does not specify the exact sample sizes (number of sutures, number of animal subjects) used for each individual test. It generally states that "Physical testing was performed" and "Animal testing was performed."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but assumed to be from studies conducted under US regulatory oversight for submission to the FDA.
  • Retrospective or Prospective: These types of tests (physical and animal implant studies) are generally considered prospective experiments specifically designed and conducted to evaluate the device against established standards.

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

This concept is not directly applicable to the evaluation of a surgical suture in this context. The "ground truth" for suture performance is established by:

• Standards bodies: (e.g., USP, ISO) defining the acceptable limits for physical properties.
• Industry best practices and scientific understanding: Guiding the design and interpretation of biocompatibility and in-vivo degradation studies.
• Qualified laboratory personnel and veterinarians/researchers: Conducting the tests and evaluating the results against established scientific protocols. No specific "experts" for ground truth adjudication in the sense of image interpretation for AI are mentioned.

4. Adjudication Method for the Test Set

Not applicable. This concept (e.g., 2+1, 3+1 for clinical disagreement) is relevant to studies involving human interpretation or clinical outcomes where there might be subjectivities. For physical and animal tests, the results are typically quantitative and objective measurements or histological assessments compared directly against predetermined criteria, not subject to adjudication in this manner.

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 or assistance device. Therefore, no MRMC study involving human readers and AI assistance was performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" used for this device evaluation is primarily:

• Standardized Measurement: Quantitative results from physical tests (e.g., suture diameter, tensile strength) compared against USP 28 specifications.
• Histopathological and Clinical Observation: For biocompatibility and implant studies, assessing tissue response, inflammation, strength loss, and mass loss over time based on established biological and pathological criteria.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical suture. This concept applies to machine learning algorithms.

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

Not applicable, as there is no training set for this device.

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TephaFLEX absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

TephaFLEX suture is a sterile, monofilament, absorbable surgical suture constructed of poly-4-hydroxybutyrate. The TephaFLEX sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

The provided text describes the TephaFLEX® Absorbable Suture and its premarket notification (K081099). However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The document details the device's classification, predicate devices, description, and indications for use, focusing on its physical and biological properties.

The "Safety and Performance" section states: "Physical testing was performed on the TephaFLEX sutures to USP 28, including Suture Diameter, Suture Needle Attachment, Tensile Strength. Animal testing was performed for conformance to ISO 10993 for biocompatibility and implant studies were conducted to demonstrate rates of tensile strength and mass loss."

This describes the types of tests conducted, but not an "acceptance criteria and reported device performance" table in the format typically used for AI/ML device evaluation, nor does it refer to a study using sample sizes, ground truth established by experts, or MRMC studies.

Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided text.

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BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.

The provided text describes a 510(k) summary for the BioElast™ 5-0 Suture. It details the device, its indications for use, and a general statement about safety and performance, but it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Specifically, the document states: "Results of bench and in-vivo testing demonstrate that the BioElast™ 5-0 Suture is biocompatible and substantially equivalent in function to the predicate devices."

This statement indicates that testing was performed and that the device was found substantially equivalent to predicate devices (Tepha, Inc., TephaFLEX® Absorbable Suture and Ethicon, Inc., PDS*II). However, it does not provide:

1. A specific table of acceptance criteria and reported device performance. The document only gives a general statement of meeting certain benchmarks through substantial equivalence.
2. Details about sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. This is typically for AI-powered diagnostic devices, not sutures.
6. Information about standalone algorithm performance. Again, this is for AI-powered diagnostic devices.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Given the nature of the device (a surgical suture) and the context of a 510(k) summary for a Class II medical device, the "acceptance criteria" here are generally implied by the regulatory standard of substantial equivalence to existing legally marketed predicate devices. This means that the new device performs as intended and is as safe and effective as the predicate devices, based on comparative bench and in-vivo testing.

Therefore, I cannot populate the requested table and detailed information as the provided text does not contain that level of detail for a medical device study typical of AI/diagnostic tools.

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