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Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture are synthetic absorbable sterile coated surgical sutures composed from a copolymer of glycolide L-lactide. This product is offered as dyed with an FDA listed color additive, D&C Violet No. 2.

This device is a surgical suture, not an AI or diagnostic device, therefore, the typical acceptance criteria and study designs provided in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies) are not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and physical properties, and conformance to recognized performance standards.

Here's a breakdown of the relevant information from the provided text:

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):

• Not applicable. No clinical trials were conducted for this submission. The evaluation was based on in-vivo/in-vitro testing and comparison to standards and a predicate device. The text states: "In-vivo/in vitro testing was provied showing that the device performed as intended and as claimed." No specific sample sizes or data provenance for these tests are mentioned.

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. Ground truth in the context of expert review for diagnostic/AI performance is not relevant here. The "ground truth" for a surgical suture is its physical and chemical properties and performance according to established standards.

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

• Not applicable. No adjudication method for a test set is mentioned or relevant to this type of device submission.

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 a diagnostic device or AI system that would involve human readers.

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

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

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

• The "ground truth" for this device is based on established industry standards and regulatory requirements for surgical sutures, including:
  • United States Pharmacopoeia (USP)
  • Mexicans United States Farmacopoeia (FEUM)
  • Applicable ISO standards (ISO 9001, ISO 13485)
  • FDA Guidance for Surgical Suture 510(k)
  • The known biocompatibility and performance characteristics of the predicate device (Vicryl®).
  • Results from in-vivo/in-vitro testing (details of which are not provided in this summary but were submitted).

8. The sample size for the training set:

• Not applicable. This is a surgical suture without a "training set" in the context of machine learning.

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

• Not applicable. No training set is involved.

Summary of the Study (Device Evaluation):

The study to "prove the device meets the acceptance criteria" for the Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture was not a clinical trial or AI performance study. Instead, it was a demonstration of substantial equivalence to a legally marketed predicate device (Vicryl® Suture, K022269 and K022715) based on:

• Technological Characteristics: The device has similar material composition (copolymer of glycolide L-lactide), is sterile, coated, and synthetic absorbable, just like the predicate.
• Physical Properties: The submission indicates that the device's physical properties are comparable to the predicate.
• Conformance to Standards: The device conforms to the requirements of the United States Pharmacopoeia (USP) (except for diameter), Mexicans United States Farmacopoeia (FEUM) for absorbable surgical sutures, ISO 9001, ISO 13485, and FDA Guidance for Surgical Suture 510(k).
• Biocompatibility: The material used is commonly employed in surgical applications and is known to be biocompatible.
• In-vivo/in-vitro testing: This testing was performed to show that the device "performed as intended and as claimed." No specific details on the methodology, sample sizes, or results of these tests are provided in the 510(k) summary, as is common for this type of submission where full test reports would be included in the larger application.

The overall conclusion was that, based on these factors, the subject device is substantially equivalent to the predicate device and is safe and effective for its intended use.

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Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.

The provided document is a 510(k) summary for a surgical suture device (Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Suture). It does not describe an AI medical device or a study involving acceptance criteria and device performance in the context of AI.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not available in the provided text.

Here's what can be extracted based on the nature of the device (a traditional medical device, not AI):

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

The document states: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." It also mentions conformance with:

• USP 30 (United States Pharmacopoeia)
• ISO 9001 and ISO 13485 (Quality Management Systems)
• FDA Guidance for Surgical Suture 510(k)

However, specific numerical acceptance criteria (e.g., tensile strength, degradation rates) and their corresponding reported device performance values are not detailed in the provided summary. The summary broadly states that the device "conforms" to these standards and performed "as intended and as claimed," which implies meeting the (unspecified in this document) acceptance criteria within those standards.

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

• Sample size: Not specified. The document only mentions "Invivo/in vitro testing."
• Data provenance: Not specified.

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

• Not applicable. This information is relevant for studies involving human interpretation or subjective assessment, typically for diagnostic or screening AI devices. For a surgical suture, performance is evaluated against physical and chemical properties.

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

• Not applicable. This is relevant for subjective assessments in diagnostic studies.

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 device. The document explicitly states: "No clinical trials were conducted."

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

• Not applicable. This is not an AI algorithm.

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

• For this type of device, the "ground truth" would be established by objective measurements against established physical, chemical, and biological standards (e.g., tensile strength, degradation profile, biocompatibility as per USP, ISO, and FDA guidance). The document refers to "Invivo/in vitro testing."

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device that requires a training set.

Summary relevant to the provided text:

The submission highlights that the device (Atramat® PGC25 Surgical Sutures) is marketed as "substantially equivalent" to predicate devices (Monocryl* (poliglecaprone 25) Suture). This equivalence is based on:

• Technological Characteristics: Similar composition (copolymer of glycolide and epsilon-caprolactone), sterile, monofilament, synthetic, absorbable.
• Performance Standards: Conformance to USP 30, ISO 9001, ISO 13485, and FDA Guidance for Surgical Suture 510(k).
• Testing: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." No clinical trials were conducted.

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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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Atramat ® Polyglycolic Acid Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. These sutures are not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid are synthetic absorbable sterile surgical sutures composed of a synthetic polyglycolic acid polymer.

Atramat® Polyglycolic acid and sorb-FAST® Polyglycolic Acid meet all requirements as described in the United States Pharmacopeia (USP) monograph for Absorbables Surgical Sutures. These products are offered as monofilament or multifilament and it is offered uncoated or coated with polycaprolactone and calcium sterarate, it could also be undyed or dyed with D&C Violet No. 2.

Sizes offered are U.S.P. 8-0 through 2 ( metric equivalent 0.4 through 5).

Materials: Polyglycolic acid. USP & Polycaprolactone and Calcium Stearate

The provided text describes a 510(k) summary for Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid surgical sutures. This submission is for a medical device and therefore the acceptance criteria and study information provided are related to demonstrating substantial equivalence to a predicate device, rather than the performance of a diagnostic or AI-driven device. As such, the typical structure for reporting on acceptance criteria for diagnostic devices (like those involving AI) does not directly apply here.

However, I can extract the information relevant to device performance and the "study" conducted to demonstrate equivalence, framed within the context of a 510(k) submission for a non-AI surgical suture.

Acceptance Criteria and Reported Device Performance

For both Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid, the core acceptance criteria revolve around meeting or exceeding the performance requirements of the United States Pharmacopeia (USP). This is the key "performance" standard for these devices.

Study Information (Non-Clinical Testing for Substantial Equivalence)

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

   • The document states "Non-clinical testing was conducted on the subject devices to prove conformance to the requirements of USP standards". It does not specify the exact sample sizes used for each test (e.g., how many sutures were tested for tensile strength or absorption rate).
   • Data Provenance: Not specified, but generally, such non-clinical testing would be performed by the manufacturer (Internacional Farmaceutica S. A. de C.V.) in Mexico, or by a contract testing laboratory. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts is relevant for diagnostic performance studies, often comparing human interpretation to a definitive answer. For medical devices like surgical sutures, "ground truth" is defined by established engineering and material science standards (e.g., USP monographs) rather than expert consensus on a diagnostic outcome. The "experts" involved would be those performing the standardized physical and chemical tests according to USP guidelines.

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

   • Not applicable. Adjudication methods are used to resolve discrepancies among multiple expert readers in diagnostic studies. Here, the "test results" are objective measurements against defined standards.

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 510(k) submission for a surgical suture, not a diagnostic device or an AI-powered system that assists human readers.

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

   • Not applicable. This is not an algorithm or AI device. The "performance" is the physical and chemical properties of the suture itself.

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

   • The "ground truth" is adherence to United States Pharmacopeia (USP) standards for absorbable surgical sutures. These are objective, quantitative specifications for material composition, physical dimensions, tensile strength, and absorption rates. For Atramat® Polyglycolic Acid, the standard is USP 24, and for sorb-FAST® Polyglycolic Acid, it is USP 26.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device. The product development and manufacturing processes would involve internal testing and quality control, but this is distinct from a "training set" in an algorithm development context.

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

   • Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the well-defined and published USP monographs.

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