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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.

This document is a 510(k) summary for the DemeMASK Surgical Mask. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered device. Therefore, many of the requested categories related to AI device studies (like expert adjudication, MRMC studies, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance for the physical properties of the surgical mask, along with details about the studies conducted to demonstrate these properties.

1. Table of Acceptance Criteria and the Reported Device Performance (Bench Testing for DemeMASK Surgical Mask)

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DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

DemeDIOX Barbed Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.

The provided text describes the submission of a 510(k) premarket notification for a medical device: DemeDIOX Barbed Absorbable Surgical Suture. This type of submission relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the study design described is focused on non-clinical testing to demonstrate conformance to established standards and comparison to predicate devices, rather than a clinical study measuring human-in-the-loop performance or outcomes in a clinical setting.

Based on the provided information, here's an analysis of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from established standards for absorbable surgical sutures, primarily the United States Pharmacopeia (USP) and ISO 10993. The reported device performance demonstrates adherence to these standards and equivalence to predicate devices.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of sutures tested) for each non-clinical test (tensile strength, diameter, length, etc.). It generally states that "Non-clinical testing was conducted... to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro resorption." and "Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 42." These tests typically involve a statistically relevant number of samples to ensure robust results, as outlined in the respective standards (USP, ISO).
• Data Provenance: The data is generated from non-clinical laboratory testing performed specifically for this 510(k) submission. No information on the country of origin of the data or whether it was retrospective or prospective is given, but non-clinical tests would inherently be prospective for the purpose of demonstrating conformance.

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

This information is not applicable to this type of submission. Ground truth, in the context of diagnostic AI or image analysis, typically involves expert human annotation or clinical outcomes. For a medical device like a surgical suture, the "ground truth" and acceptance criteria are defined by established performance standards (USP, ISO) and comparison to predicate device characteristics as detailed in their respective 510(k) clearances. The performance is measured against these objective standards through physical and chemical testing, not through expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human experts are making subjective assessments, often in diagnostic accuracy studies. For testing a physical device like a suture, the "adjudication" is inherent in the standardized testing process where results are objectively measured against defined criteria.

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

No, a MRMC comparative effectiveness study was not done.

• This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., AI-assisted radiology).
• The device in question, DemeDIOX Barbed Absorbable Surgical Suture, is a physical surgical suture, not a diagnostic or AI-powered device that assists human readers.
• The submission explicitly states: "No clinical trials were conducted."

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

No, a standalone study (in the context of an algorithm or AI) was not done.

• This is not an AI/algorithm-based device.
• The performance assessment for this device is based on its physical properties, material characteristics, and biological compatibility as measured directly through laboratory tests and comparisons to predicate devices, not through an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on:

• Established Industry Standards: Primarily the United States Pharmacopeia (USP 42) monographs for absorbable surgical sutures, which define physical and chemical performance requirements (tensile strength, diameter, length, etc.).
• International Standards: ISO 10993-1 for biocompatibility.
• Predicate Device Characteristics: Demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices (Ethicon PDS Barbed Suture and DemeTECH Polydioxanone Synthetic Monofilament Suture) in terms of intended use, technology, and safety/performance profile.

8. Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (surgical suture), not a machine learning model or an AI algorithm. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of the suture material and manufacturing process would involve internal R&D and quality control, but not a formally defined "training set" for an AI.

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

This information is not applicable as there is no "training set" for an AI algorithm in this context. The "ground truth" for the development and testing of the suture is established by the well-defined and often long-standing scientific and engineering principles of material science, biomaterials, and surgical product design, all guided by regulatory standards like USP and ISO.

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

DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is available in different colors and may be provided with or without an attached needle(s).

This document is a 510(k) summary for the DemeTECH DemeFORCE Nonabsorbable Surgical Suture. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for an AI/ML algorithm or diagnostic tool. Therefore, much of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted or inferred from the provided text, focused on the non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each non-clinical test. It states "Non-clinical testing was conducted on the device... to prove conformance to the requirements of USP." The provenance of the data is from in-house non-clinical testing performed by DemeTECH Corporation, as described in the "Non-Clinical Tests Performed" section. It is not retrospective or prospective patient data from a specific country, but rather laboratory testing of the device itself.

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

This information is not applicable to this type of submission. Ground truth in this context refers to established standards (USP monographs, ISO 10993) and the results of laboratory tests. There is no mention of human experts establishing ground truth for a "test set" in the context of imaging or diagnostic evaluations.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "test set" is the physical device being tested against predefined technical 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

Not applicable. This document is for a surgical suture and does not involve AI, human readers, or diagnostic interpretation.

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

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

7. The type of ground truth used

The ground truth used for the non-clinical tests were:

• Established standards: United States Pharmacopeia (USP) monographs for nonabsorbable surgical sutures (specifically USP 41), and FDA's Special Control Guidance Document: Surgical Sutures.
• International standards: ISO 10993-1 for biocompatibility.
• Predicate device characteristics: For demonstrating substantial equivalence in areas like in-vitro and in-vivo resorption.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

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The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.

DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).

The provided document describes the FDA 510(k) clearance for the DemeTECH PTFE Nonabsorbable Surgical Suture. This is a medical device, not an AI/ML device, therefore, many of the requested criteria are not applicable. However, I can extract the relevant information regarding acceptance criteria and the studies performed.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes for the non-clinical tests (e.g., number of sutures tested for tensile strength, needle attachment).
• The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to meet USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards, which are internationally recognized. The studies were non-clinical (laboratory/bench top) and in-vitro/in-vivo.
• The study was not a "test set" in the context of an AI/ML model; rather, it was a series of physical and biological tests on the device itself.

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

• This question is not applicable as the device is a surgical suture, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is its physical and biological performance as measured by established standards.

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

• This is not applicable as there was no "test set" in the context of human interpretation or AI/ML model output requiring adjudication. The tests involved direct measurement against predefined 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. No MRMC study was conducted as this is a physical medical device (suture), not an AI/ML diagnostic or assistive tool. No human "readers" are involved in its performance assessment in this context.

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

• This is not applicable. This is a physical nonabsorbable surgical suture, not a software algorithm or AI/ML device.

7. The type of ground truth used:

• The "ground truth" for the device's performance was established by internationally recognized standards:
  • United States Pharmacopeia (USP 39) monograph for nonabsorbable surgical sutures: This defines the physical and performance characteristics such as diameter, length, knot pull tensile strength, and needle attachment strength.
  • ISO 10993-1 for Biocompatibility: This defines the standards for evaluating the biological safety of medical devices.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device and does not involve AI/ML models that require training sets.

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

• This is not applicable for the same reason as point 8.

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DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.

The provided text describes a 510(k) premarket notification for a medical device, the DemeDIOX Absorbable Surgical Suture. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI/algorithm-based medical device. Therefore, much of the requested information regarding AI study details (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from this document, as it pertains to a physical surgical suture.

However, I can extract the acceptance criteria and the "device performance" in terms of compliance with standards and equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For DemeDIOX Absorbable Surgical Suture, the "acceptance criteria" are compliance with established regulatory and pharmacopeial standards, and "device performance" is demonstrated by meeting or exceeding these requirements and showing substantial equivalence to a predicate device.

Regarding the study that proves the device meets the acceptance criteria:

The "study" in this context refers to a series of non-clinical tests and demonstrations of equivalence to a legally marketed predicate device.

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 for Test Set: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was done on the DemeDIOX Absorbable Surgical Suture itself, likely using batches or representatives of the manufactured suture according to standard test methods for medical devices (e.g., USP monographs).
• Data Provenance: Not specified. Being a US FDA submission, the tests were presumably conducted in facilities adhering to relevant good laboratory practices (GLP), but the country of origin of the specific data is not mentioned.
• Retrospective or Prospective: Not applicable in the conventional sense for non-clinical device testing. These were pre-market, non-clinical performance and equivalence tests conducted specifically for this submission.

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 physical surgical suture, not an AI/algorithm-based diagnostic device where expert ground truth establishment for a test set would be relevant. Compliance was assessed against established pharmacopeial and ISO standards.

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

Not applicable. This is not an AI/algorithm study involving human interpretation or 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 physical medical device (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.

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

The "ground truth" for the device's performance is established by its compliance with:

• The United States Pharmacopeia (USP) monographs for absorbable surgical sutures (e.g., USP 40, USP 41).
• ISO 10993-1 for biocompatibility.
• General device requirements and FDA Guidance for Surgical Sutures 510(k).
  These are objective, quantitative standards for material properties, sterility, and biological safety.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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