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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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"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.

Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".

This document describes the Demetech Non-Absorbable Stainless Steel Surgical Suture (DemeSTEEL) and its equivalency to predicate devices, primarily through non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages the United States Pharmacopeia (USP) standards as its primary acceptance criteria. The device is reported to meet or exceed these standards.

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It generally states that "Non-clinical testing was conducted on the device to prove conformance to the requirements of USP standards." The data provenance is laboratory testing conducted by Demetech, likely in the US, given the company's address and the FDA submission. The data is prospective, generated specifically for this submission.

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

Not applicable. This is a medical device submission primarily based on objective physical and chemical testing against established standards (USP, ASTM). There were no experts involved in establishing a "ground truth" in the way it is typically understood for interpretative tasks (e.g., medical image analysis). The "ground truth" here is adherence to specified material and performance parameters.

4. Adjudication Method for the Test Set:

Not applicable. No adjudications were performed as this primarily involves objective measurements of physical and chemical properties 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:

Not applicable. This is a submission for a surgical suture, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study was conducted or is 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 (suture), not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" used is defined by:

• Established Industry Standards: United States Pharmacopeia (USP) for non-absorbable surgical sutures, including specific sections for diameter, tensile strength, needle attachment, suture length, and sterility.
• Material Specifications: ASTM Standard F138 Grade 2 for 316L stainless steel.
• Biocompatibility Standards: Implicitly, common standards for biocompatibility testing for implantable devices, with the 316L material having an "established history of use."

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. As noted above, there is no "training set." The performance of the suture is assessed against predefined, universally accepted physical and chemical standards.

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DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.

DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.

Here's an analysis of the provided text regarding the DemeQUICK (Rapid Absorbable) Surgical Suture, structured to address your requested points about acceptance criteria and the study proving compliance:

The document provided is a 510(k) summary, which is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device. For this type of submission, extensive clinical trials with human subjects as we typically associate with "AI studies" are generally not required. Instead, the focus is on non-clinical testing to demonstrate performance equivalence to established standards and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DemeQUICK Absorbable Suture are based on conformance to the requirements of the United States Pharmacopeia (USP) for absorbable sutures and demonstrating substantial equivalence to the specified predicate devices (Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide®). The reported device performance is consistently stated as "Same" relative to the predicate devices, implying that DemeQUICK meets or exceeds these criteria.

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

The document does not explicitly state specific sample sizes for each non-clinical test conducted (e.g., number of sutures tested for tensile strength or diameter). It mentions "Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture..." This implies that standard methods outlined in the USP were followed, which would have specified sample sizes for such tests.

• Test Set Sample Size: Not explicitly stated for individual tests, but implied to follow USP guidelines.
• Data Provenance: The testing was conducted in a non-clinical setting to conform to USP requirements and establish biocompatibility (ISO 10993-1). The nature of these tests (e.g., physical property measurements, in-vitro/in-vivo resorption studies) suggests laboratory-based data, not necessarily tied to a specific country of origin in the way clinical data would be. The data is retrospective in the sense that it's generated from manufactured product for regulatory submission.

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

This request is not directly applicable to this type of device submission. For surgical sutures, "ground truth" is not established by expert clinical consensus in the way seen with diagnostic AI studies. Instead, the "ground truth" for acceptance is defined by:

• USP Monograph Requirements: These are objective, measurable physical and chemical properties (e.g., minimum tensile strength, diameter tolerances) established by a pharmacopeial authority.
• Biocompatibility Standards: ISO 10993-1 provides a framework for evaluating biological responses to medical devices via standardized tests, not expert opinion.
• Performance of Legally Marketed Predicate Devices: The DemeQUICK suture is compared against two existing, approved sutures. Their performance serves as a benchmark for equivalence.

Therefore, no clinical experts are involved in establishing the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for this type of device is based on objective, standardized physical, chemical, and biological tests, not on subjective assessment or consensus among clinical experts.

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 relevant for diagnostic devices (often AI-powered) where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. For a surgical suture, the effectiveness is proven through physical performance, biocompatibility, and absorption characteristics, not through human reader interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The testing conducted for the DemeQUICK suture is analogous to "standalone" performance. The device's physical and chemical properties, as well as its biocompatibility and absorption profile, are evaluated independently against specified standards and predicate devices, without involving a human practitioner's real-time interaction or interpretation in a clinical setting as part of the primary equivalence demonstration.

7. The Type of Ground Truth Used

The ground truth used for DemeQUICK's assessment is primarily:

• Standardized Specifications: The official Monograph of the United States Pharmacopeia (USP) requirements for absorbable surgical sutures, including specific tests for diameter, tensile strength, needle attachment, and length.
• Biocompatibility Standards: ISO 10993-1 guidelines for biological evaluation of medical devices.
• Performance Data from Predicate Devices: The established performance characteristics of Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide® sutures act as a comparative "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This concept is not applicable here. A "training set" is used for machine learning or AI models. This submission is for a physical medical device (suture) and does not involve AI.

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

Not applicable, as there is no training set for an AI model.

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Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.

DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable surgical suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied un-dyed and dyed with D&C Violet #2 below 0.1wt%. DemeCAPRONE (Poliglecaprone 25) synthetic absorbable suture is available in sizes 6-0 through 1 (metric sizes 0.7 - 4). DemeCAPRONE (Poliglecaprone 25) Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures except for diameter.

The provided document describes the 510(k) summary for DemeCAPRONE (Poliglecaprone 25) Synthetic Monofilament Absorbable Suture. This document focuses on demonstrating substantial equivalence to predicate devices for a surgical suture, not an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, while acknowledging the inherent differences for a sutures submission:

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

The acceptance criteria for DemeCAPRONE (Poliglecaprone 25) suture are based on demonstrating equivalence to legally marketed predicate devices and conformance to established standards, primarily the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures, and ISO 10993 for biocompatibility.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of sutures tested for tensile strength, length, etc.). However, it states that "Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and invivo and in-vitro resorption." This implies that the sample sizes used were in accordance with the specified standards and guidance documents.
• Data Provenance: The studies were non-clinical (laboratory and animal studies for biocompatibility, in-vivo/in-vitro resorption). The location of the testing facilities is not explicitly stated, but the applicant is Demetech Corporation, Miami Lakes, FL, USA.
• Retrospective or Prospective: The testing would have been prospective, as new tests were performed on the DemeCAPRONE suture to demonstrate its properties.

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 for this type of device submission. Ground truth, in the context of AI/ML, refers to human expert annotations. For a surgical suture, the "ground truth" is adherence to physicochemical and biological standards (e.g., USP monographs, ISO 10993). The "experts" would be the scientists and technicians conducting the non-clinical tests and interpreting the results against established specifications, not medical domain experts creating ground truth for an algorithm.

4. Adjudication method for the test set:

• This is not applicable. Adjudication methods are used in consensus agreement among human annotators, which is not relevant for the objective physical and chemical testing of a surgical suture. The results are quantitative measurements compared against predefined acceptance limits.

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. An MRMC study is for evaluating observer performance (e.g., radiologists interpreting images). This submission is for a physical medical device (suture) and does not involve human "readers" or AI assistance.

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

• This is not applicable. This describes the performance of a standalone AI algorithm. The DemeCAPRONE suture is a physical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the device's performance is established by objective, established standards and methodologies.
  • Pharmacopeia Standards (USP): These define the chemical, physical, and pharmaceutical quality of drugs and medical devices. For sutures, this includes specifications for tensile strength, diameter, length, sterility, etc.
  • ISO 10993 Biocompatibility Standards: These define methods for evaluating the biological response to medical devices.
  • Predicate Device Performance: Part of the substantial equivalence relies on demonstrating that the new device's properties (including resorption) are similar to those of previously cleared predicate devices.

8. The sample size for the training set:

• This is not applicable. There is no "training set" in the context of this 510(k) submission for a surgical suture. Training sets are used for machine learning models.

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

• This is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

In Conclusion:

The DemeCAPRONE suture's acceptance is based on demonstrating substantial equivalence to predicate devices and conformance to recognized consensus standards (USP) and international standards (ISO 10993). The "study" proving this involves a battery of non-clinical (laboratory and animal) tests rather than clinical trials or AI/ML-specific performance studies. The primary evidence presented is the declaration that DemeCAPRONE "meets or exceeds" the relevant performance requirements and is "Same" in composition, design, and manufacturing process to established predicate devices.

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Demetech 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, 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.

Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.

This 510(k) summary describes a Polydioxanone Synthetic Absorbable Monofilament Suture by Demetech Corporation, seeking substantial equivalence to existing predicate devices.

The document does not report on a study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study with a defined acceptance criterion and specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture and Ethicon PDS II Synthetic Absorbable Monofilament Suture) by showing that the new device has the same technological characteristics and meets the same performance requirements as defined by the United States Pharmacopeia (U.S.P.) for absorbable surgical sutures.

Therefore, the requested information elements related to diagnostic performance studies, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of device submission.

Here's the information that can be extracted or deduced from the provided text:

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

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

• Not Applicable. This submission does not detail a "test set" in the context of a clinical performance study. The performance evaluation is based on meeting established material and performance standards (USP) which are generally tested in laboratory settings.

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 accuracy is not relevant to this type of device (surgical suture). The ground truth here is the established, published standards of the United States Pharmacopeia.

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

• Not Applicable. Adjudication methods are for reconciling discrepancies among expert reviewers in diagnostic studies, which is not relevant 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 surgical suture, not an AI-assisted diagnostic device.

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 demonstrating equivalence is adherence to the United States Pharmacopeia (USP) 31 standards for synthetic absorbable surgical sutures, as well as comparison to the characteristics of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This submission does not involve a "training set" in the context of machine learning.

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

• Not Applicable. This submission does not involve a "training set" in the context of machine learning.

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Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".

Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

The provided document is a 510(k) summary for the Demetech Absorbable Surgical Gut Suture (Plain and Chromic), demonstrating substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), expert involvement, and ground truth establishment is not applicable in this context.

However, I can extract the relevant information from the document to address the aspects that are present:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here refers to meeting the performance requirements defined by the United States Pharmacopeia (USP) for absorbable surgical sutures, specifically USP 23 and the current edition USP 24. The reported device performance is that Demetech's suture "meets or exceeds" these requirements.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data in the context of AI/ML. The performance testing is likely conducted on batches of manufactured sutures. The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is established by standardized physical tests, not expert consensus.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
The ground truth used for evaluating the Demetech suture is standardized physical tests against the requirements of the United States Pharmacopeia (USP 23 and USP 24). This includes:

• General performance requirements for "Absorbable Surgical Suture"
• Specific requirements for "Diameter" ()
• Specific requirements for "Tensile Strength" ()
• Specific requirements for "Needle Attachment" ()
• Specific requirements for "Finish suture Length Requirement" (95% of stated label length)

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established: Not applicable.

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