Search Results

Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.

The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter

The provided text describes a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device, and its 510(k) submission for clearance. However, it does not contain information about a study that establishes acceptance criteria and proves the device meets those criteria in the context of AI/ML device performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. This process typically involves non-clinical laboratory performance testing to show that the new device (in this case, an additional suture diameter size) performs comparably to the predicate and meets relevant standards (like USP monograph for absorbable sutures).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, acceptance criteria, sample sizes for test/training sets, ground truth, experts, adjudication methods, or MRMC studies. These details are not present in the provided text.

The closest relevant information is about the performance tests conducted to demonstrate substantial equivalence, which primarily involve non-clinical laboratory testing.

Here's what can be extracted from the document:

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

• Acceptance Criteria (Implied): Conformance to the USP monograph for absorbable sutures (as applicable).
• Reported Device Performance: "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device."
• Additional Tests Performed: In vitro post-hydrolysis tensile testing and in vivo resorption testing.

The following questions cannot be answered from the provided text as they pertain to AI/ML device performance studies, which are not described:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or 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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

Quill™ MONODERM™ device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The Quill™ Monoderm™ Knotless Tissue-Closure Device is a sterile, synthetic absorbable tissue approximation device that is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Sizes 0 to 5-0, in various lengths affixed to various needle types.

The provided text describes a 510(k) premarket notification for a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device (PGA-PCL). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria in the manner typical for AI/ML-based devices.

Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, standalone performance, training set details, or expert ground truth establishment) are not applicable to the information contained in this submission.

Here's an analysis of the provided text in relation to your questions, focusing on the available information:

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

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 does not specify sample sizes for the performance tests (USP monograph, in vitro tensile, in vivo resorption). It also does not provide details about the provenance of the data, such as country of origin or whether the studies were retrospective or 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)

This type of information is not relevant or provided for this device type (a surgical suture). Ground truth, in the context of this device, would be defined by standardized chemical and physical tests rather than expert interpretation of data.

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

Not applicable to the type of device and testing described. Performance was assessed via laboratory and in-vivo testing, not through adjudication of expert opinions.

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/ML-based diagnostic device where MRMC studies would be relevant.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance would be established through:

• Physical and chemical standards: As defined by the USP monograph for absorbable sutures.
• Direct measurement: Of properties like tensile strength and resorption rates in vitro and in vivo.
  The "ground truth" is objective measurement against established standards and comparisons to the predicate device, not expert consensus or pathology in the typical sense.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set as this is not an AI/ML device.

Ask a specific question about this device

MONODERM™ (PGA-PCL) suare 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.

Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ (PGA-PCL) Surgical Suture, structured according to your request:

Acceptance Criteria and Study for Monoderm™ (PGA-PCL) Surgical Suture

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in terms of individual sutures tested. The reference is to "performance testing" being conducted. The data provenance is implied to be from non-clinical laboratory testing conducted by the company, Surgical Specialties Corporation, likely in the USA (given the company's address and FDA submission). The nature of the testing suggests it is prospective in the sense that the new Monoderm™ (PGA-PCL) suture was manufactured and then subjected to these tests to evaluate its properties.

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

This information is not provided in the document. The "ground truth" for suture performance is typically established by physical and chemical properties measured against established standards (like the USP monograph), rather than expert human interpretation of images or other subjective data. Therefore, expert consensus in the traditional sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human review of subjective data, typically in diagnostic imaging or clinical trials where expert consensus is needed. For product performance testing of a physical device like a suture, the assessment is based on measured physical properties against predefined specifications, not human adjudication of subjective findings.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a physical surgical suture, not an AI device.

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

No, a standalone study (in the context of an algorithm) was not done. This submission is for a physical surgical suture.

7. The Type of Ground Truth Used

The ground truth used for evaluating the suture's performance is based on:

• Established standards and specifications: Specifically, the USP monograph for absorbable sutures.
• Comparative data against a legally marketed predicate device: "in vitro post-hydrolysis tensile testing" to demonstrate substantial equivalence. This implies that the predicate device's performance characteristics served as a reference "ground truth" for comparison.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This submission is for a physical medical device (suture) and does not involve an algorithm or AI model that requires a training set.

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

This information is not provided and is not applicable as there is no training set for an algorithm in this context.

Ask a specific question about this device

Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 1 to 3-0, in various lengths affixed to various needle types.

This document describes the premarket notification (510(k)) for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for the "test set" in the context of human data or clinical study. The performance testing described is non-clinical laboratory performance testing. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to human subjects is not applicable here.

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

Not applicable. The ground truth for this device's performance is established through non-clinical laboratory testing according to established standards (USP monograph) and direct comparison to predicate devices, not through expert consensus on a test set of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This device is a physical surgical suture, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for this device includes:

• USP Monograph Standards: For tensile strength and needle attachment. These are well-defined, established standards for absorbable sutures.
• Predicate Device Performance Data: For in vitro post-hydrolysis tensile testing, the performance of the predicate devices serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (suture) and does not involve AI or machine learning.

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

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

Ask a specific question about this device

Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill TM Monoderm TM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 2-0 to 0 in various lengths affixed to various needle types.

This document describes the 510(k) submission for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. The device is an absorbable surgical suture. The submission focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Acceptance Criteria and Device Performance Study Information:

This 510(k) summary does not include detailed acceptance criteria or a "performance table" in the typical sense of a diagnostic device's metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the requirements of the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document for Surgical Sutures. The device's performance is demonstrated by meeting these standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Non-clinical laboratory performance testing was conducted." However, it does not specify the sample size used for the various tests (tensile strength, needle attachment, in vitro post-hydrolysis tensile testing).

The data provenance is non-clinical laboratory testing. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as these concepts are generally not applicable to laboratory performance testing of this nature.

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

This type of information is not applicable to this device's submission. The "ground truth" for a surgical suture is defined by established engineering and material science standards (e.g., USP monographs, FDA guidance). Expert review, as in clinical or imaging studies, is not part of establishing the performance for these specific non-clinical tests.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple reviewers assess outcomes or image interpretations. For laboratory performance testing, the results are objectively measured against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on their performance. The Quill™ Monoderm™ device is a surgical suture, not a diagnostic tool requiring human interpretation in this context.

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

This information is not applicable. The device is a physical surgical suture, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing is based on established industry standards and regulatory requirements. Specifically:

• USP monograph for absorbable sutures for tensile strength and needle attachment.
• FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
• The characteristics and performance of the legally marketed predicate devices to which equivalence is claimed.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a surgical suture, not a machine learning model that requires a training set. The performance testing described is for product verification and validation, not for algorithm training.

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

This information is not applicable as there is no training set for this type of medical device submission.

Ask a specific question about this device

Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone. undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 2-0 in various lengths affixed to various needle types.

The provided document is a 510(k) summary for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. It describes the device, its indication for use, and a general statement about performance testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information to fully address all parts of your prompt.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative values or pass/fail thresholds. The document generally refers to conforming to the USP monograph for absorbable sutures and demonstrating substantial equivalence.
• Reported Device Performance: The document states that "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices." No specific performance metrics (e.g., actual tensile strength values, degradation rates) are provided.

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

• Sample Size: Not specified.
• Data Provenance: The document only mentions "testing" and "simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing." It does not specify country of origin, retrospective or prospective nature, or where the testing was conducted.

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. This device is a surgical suture, and the performance tests described are mechanical and material characterization studies, not image interpretation or diagnostic studies that would require expert consensus for ground truth.

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

• Not applicable. See point 3.

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 is not an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• For the non-clinical laboratory performance testing (tensile strength, needle attachment), the "ground truth" would be established by standardized measurement techniques and USP monograph specifications.
• For the simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing, the "ground truth" would be the measured physical properties of the device and the predicate devices, compared against each other.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device that requires a training set. The performance tests are experimental studies, not algorithm training.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary offers a high-level overview of the device and the types of performance testing conducted to support substantial equivalence. It lacks the detailed quantitative data, sample sizes, and specific methodologies that would be required to fully answer most of your detailed questions, particularly those related to clinical studies, AI performance, or expert-adjudicated ground truth, as those concepts do not apply to this type of device and submission.

Ask a specific question about this device

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

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). It is available sterile, dyed violet (D&C Violet No. 2 per 21 CFR 74.3602) or undyed (beige) in various suture lengths and needle configurations in USP Sizes 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each QuillTM Self-Retaining System (SRS) comprised of MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ breaks, the remaining suture passes will hold the wound edges in approximation.

The provided text describes a 510(k) premarket notification for the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ sutures. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and measured performance metrics in the way one would for a new clinical device or AI algorithm.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Not applicable in the traditional sense for this 510(k))

This 510(k) submission does not establish performance acceptance criteria in the form of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it report device performance as such. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.

The study referenced is an animal study comparing the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ to MONOCRYL sutures to assess the capabilities of barbs to knots in maintaining wound approximation. However, the document does not provide specific performance data or statistical analysis from this study. It only states that the study was conducted to "assess the capabilities."

Table of "Acceptance Criteria" (Substantial Equivalence Factors) and "Reported Device Performance" (Comparison to Predicates):

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

• Sample Size: Not specified in the provided document. The submission mentions "animal studies" comparing the device to MONOCRYL, but does not provide details on the number of animals or specific experimental groups.
• Data Provenance: Not specified. The animal studies would typically be prospective, but the location of the study is not mentioned.

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

• Not Applicable. This type of information is generally relevant for studies involving qualitative assessments or diagnostic accuracy by human readers, often in medical imaging or pathology. This 510(k) submission describes a physical medical device (suture) and relies on animal studies for performance, not expert ground truth for a diagnostic task.

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

• Not Applicable. Adjudication methods are typically used when multiple human experts provide assessments that need to be reconciled, which is not the case for an animal study of suture performance as described here.

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 510(k) submission for a surgical suture, not an AI algorithm or a diagnostic tool that involves human readers.

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

• Not Applicable. This is a 510(k) submission for a surgical suture, not an algorithm.

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

• The "ground truth" in the context of the animal studies would likely relate to objective measures of wound approximation/healing, tensile strength retention, or inflammatory response, as assessed by veterinary pathologists or other scientific measures in an animal model. Specific methods are not detailed in this submission.

8. The sample size for the training set

• Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.

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

• Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.

Ask a specific question about this device

Monoderm™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.

MonodermTM suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ Synthetic Absorbable Surgical Suture:

This 510(k) summary describes a surgical suture, which is a medical device. The regulatory pathway for such devices often relies on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information provided focuses on material properties and performance characteristics, aligning with physical and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Physical testing was performed on Monoderm™ Synthetic, Absorbable sutures" and "Animal testing was performed," but does not specify the number of sutures or animals used for these tests.
• Data Provenance: The document implies prospective testing conducted by the manufacturer, Surgical Specialties Corporation. The origin of the data is internal to the company (Reading, PA, USA) and refers to standardized testing methods (USP, ISO). No country of origin for specific human patient data is mentioned as such studies are not described for this type of device submission.

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

• This type of information is not applicable to this submission. For physical and material performance testing like those described (suture diameter, tensile strength, biocompatibility, absorption rates), "ground truth" is established through standardized laboratory measurements and scientific protocols, not expert consensus on interpretations of imagery or clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" involves physical and animal testing, there is no need for expert adjudication in the way it would be applied to, for example, diagnostic image interpretation. Results are generated through objective measurements and adhere to specified test methods (USP, ISO).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This type of study assesses human reader performance with or without AI assistance, which is irrelevant for a surgical suture and its 510(k) submission based on manufacturing and material performance data.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This device is a physical surgical suture, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

• The "ground truth" for the performance criteria described is established through:
  • Standardized Laboratory Measurements: For physical properties like suture diameter, tensile strength, and needle attachment, the ground truth is the numerical value obtained from calibrated instruments following USP protocols.
  • Animal Studies/Biological Assays: For biocompatibility and absorption rates (tensile strength and mass loss over time), the ground truth is derived from the biological responses observed in in vivo animal models and in vitro assays according to ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. This submission does not involve an AI algorithm that requires a "training set" in the machine learning sense. The device is a manufactured product whose performance is evaluated against established physical and biological standards.

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

• Not applicable. As there is no AI training set, there is no ground truth to be established for it. The ground truth for the device's performance relates to its compliance with USP and ISO standards, as outlined in item 7.

Ask a specific question about this device

Monoderm™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.

Coated Monoderm™(Polyglactone 72) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by coating Monoderm™ suture with a mixture of caprolactone, glycolide and glycolic acid.

The provided text describes a 510(k) summary for a surgical suture device (Monoderm™), which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the kind of details requested.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth for training set) are not applicable or not provided in this type of regulatory submission.

However, I can extract information related to performance data and equivalency claims as much as possible.

Here's a breakdown of the available information:

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

This information is not presented in a table format with explicit acceptance criteria values. Instead, the document states general conformance to standards and describes performance relative to 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)

• Sample Size: Not specified in the provided text. The document mentions "Physical testing" and "Animal testing" but does not give the number of samples or animals used.
• Data Provenance: Not specified. The studies were performed by Surgical Specialties Corporation. The country of origin of the data is not mentioned. Whether studies were retrospective or prospective is also not stated, but typically, these types of tests for product clearance are 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. This is not the type of device or study that typically involves expert ground truth for a test set in the way an AI diagnostic device would. Performance is assessed against physical and biological standards.

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

• Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this physical and biological product testing.

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 that assists human readers.

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

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

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

• For physical testing (diameter, needle attachment, tensile strength), the "ground truth" would be established by standardized measurement techniques defined by USP 27.
• For biocompatibility and implant studies, the "ground truth" would be established by histopathological examination and assessment of biological responses according to ISO 10993 guidelines, and measurement of physical properties (tensile strength, mass loss) over time.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML product developed with training sets.

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

• Not applicable. This device is not an AI/ML product developed with training sets.

Ask a specific question about this device