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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" (<861>)
• Specific requirements for "Tensile Strength" (<881>)
• Specific requirements for "Needle Attachment" (<871>)
• 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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The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.

The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.

This 510(k) summary (K043330) is for a medical device called "DemeTECH Polypropylene Surgical Sutures." It demonstrates substantial equivalence to a predicate device, the Pronova Non-Absorbable Suture (K001625), rather than providing a study proving a device meets specific performance criteria.

Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information from the provided text.

Here's a breakdown of the acceptance criteria and related information based only on the provided text, acknowledging that a full clinical study with the listed criteria is not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) submission like this are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific performance criteria in the way a clinical trial or a standalone diagnostic study would. Instead, the "study" is the comparison made to the predicate device to satisfy the FDA's requirements for substantial equivalence.

The regulatory review process itself, based on the information provided in the 510(k) submission, served as the "proof" that the device meets the acceptance criteria for a 510(k) clearance. The FDA's letter (K043330, May 16, 2005) confirms that the device was determined to be "substantially equivalent."

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

• Sample Size: Not applicable. This document does not describe a clinical "test set" with a specific sample size in the context of typical device performance studies (e.g., patient data). The "test" is a comparison to the predicate device's specifications and performance.
• Data Provenance: Not applicable. The data is primarily comparative information from existing device specifications and regulatory submissions.

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

• Not applicable. This document does not involve experts establishing ground truth for a test set of data. The "ground truth" for a 510(k) comparison is the known, cleared specifications and performance of the chosen predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" in the context of a 510(k) comparison as there would be for a multi-reader study. The FDA reviews the provided data against the predicate device's known characteristics and regulatory standards.

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

• No. This is not an MRMC study. It is a 510(k) submission for a surgical suture.

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

• The "ground truth" in this context is the established specifications, performance, and regulatory clearance of the predicate device (Pronova Non-Absorbable Suture - Ethicon K001625). The applicant (DemeTECH) asserts that their device is substantially equivalent to this predicate.

8. The Sample Size for the Training Set

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

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

• Not applicable. This is not an AI/ML device.

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The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2.

PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.

This is a 510(k) premarket notification for a medical device called "DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles". The provided text describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device (K984374 Surgisorb - Samyang Corp.).

However, the provided document does not contain a study with acceptance criteria and reported device performance in the way typically found for AI/imaging devices. This document is a regulatory submission for a physical medical device (sutures), not a software or AI device that relies on performance metrics like sensitivity, specificity, or accuracy derived from a test set of data.

Therefore, most of the questions you've asked, which are geared towards AI/software device studies, cannot be answered from this document.

For completeness, I can address the parts that are relevant to this type of traditional medical device submission:

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

• Acceptance Criteria: For this type of device, acceptance criteria are typically related to meeting established standards (e.g., USP and European Pharmacopoeia for sterile, synthetic, absorbable sutures) and demonstrating substantial equivalence to a legally marketed predicate device.
• Reported Device Performance: The document states, "PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures." This is the reported performance in relation to the established standards. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the primary "performance" metric in a 510(k) – demonstrating equivalence.

The following questions cannot be answered from the provided document as they pertain to AI/software device studies, not traditional medical device submissions like sutures:

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

In summary, the provided document is a 510(k) summary and FDA clearance letter for a physical medical device (sutures). It demonstrates compliance with recognized standards and substantial equivalence to a predicate device, which are the primary "performance" aspects for such a submission. It does not involve a study with a test set, ground truth established by experts, or AI performance metrics as described in your questions.

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The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.

The provided text is related to the 510(k) submission for the DemeTECH Nylon Nonabsorbable Suture. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to USP standards for a medical device (suture), not an AI/ML powered device. Therefore, many of the requested categories for AI/ML study information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can provide the acceptance criteria table and the reported device performance, which is focused on equivalence and meeting safety/performance standards, as detailed in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The following information cannot be extracted from the provided text for this medical device (suture), as these concepts typically apply to AI/ML powered devices or clinical efficacy studies that are not detailed in a 510(k) summary for a non-active medical device:

2. Sample size used for the test set and the data provenance: Not applicable/not provided for a suture's physical performance testing. Testing would typically involve laboratory analysis of material properties.
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 based on standardized physical and chemical tests.
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, as this is a physical medical device (suture) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For a suture, ground truth is based on standardized physical and chemical properties as defined by the USP (United States Pharmacopeia) and established engineering/material science principles.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of a physical medical device like a suture.
9. How the ground truth for the training set was established: Not applicable.

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The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually packaged nonabsorbable Polyester surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes.

The DemeTECH Polyester Nonabsorbable Suture is a medical device and thus does not involve AI/ML performance.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The study involved testing the physical properties of sutures against USP standards and comparing them to a predicate device, not analyzing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by adherence to published United States Pharmacopeia (USP) standards, which are defined by scientific testing methodologies rather than expert consensus on individual cases.

4. Adjudication method: Not applicable. The assessment was based on physical property testing against USP 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 medical device for surgical procedures, not an AI/ML diagnostic tool.

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

7. The type of ground truth used: The ground truth used was based on established United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. This involves standardized physical and chemical testing methods to ensure quality and performance. Additionally, equivalence to a legally marketed predicate device (Grams Polyester Nonabsorbable Suture) served as a benchmark.

8. The sample size for the training set: Not applicable. This is a medical device, not an AI/ML model that requires a training set. The study involves quality control testing for manufacturing standards.

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

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The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DemeTECH Silk Nonabsorbable Suture:

This document is a 510(k) summary for a medical device regulatory submission, not a detailed scientific study publication. As such, it focuses on demonstrating substantial equivalence to a predicate device and compliance with established standards, rather than presenting a comprehensive research study with detailed methodology and extensive performance data common for novel high-risk devices.

Based on the provided information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a "test set" in the context of a clinical trial or performance study. The evaluation appears to be based on physical and material properties testing to demonstrate compliance with USP standards and equivalence to the predicate device. No details about data provenance (e.g., country of origin, retrospective/prospective) are provided, as this type of information is typically associated with clinical data.

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

Not applicable. This submission relies on established standards (USP) and comparison to a legally marketed predicate device. There is no mention of "ground truth" derived from expert consensus in a clinical context for this type of device. The "experts" involved would be those performing the specified physical and chemical tests to USP standards and those reviewing the equivalence claims.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts assess cases to establish a consensus ground truth. This is not the type of study described here.

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

No. An MRMC study is relevant for imaging or diagnostic AI devices where human readers interpret data with and without AI assistance. This device is a surgical suture, and such a study is not applicable to its evaluation.

6. Standalone Performance Study

The statement "The DemeTECH Silk Nonabsorbable Suture has been demonstrated as both equivalent to the predicate device and meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures" indicates that standalone performance (i.e., the suture itself meeting defined metrics) was evaluated against the USP standards. This could be considered a form of standalone testing, though not in the context of an "algorithm only" as typical for AI. The "study" here refers to the testing conducted to show compliance with these material standards.

7. Type of Ground Truth Used

The "ground truth" used for this device is based on United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures and the specifications of the legally marketed predicate device (Grams Silk Nonabsorbable Suture). This means the device's physical, chemical, and performance characteristics were compared against established, standardized benchmarks.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant 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 above, there is no AI training set involved. The "ground truth" for the device's characteristics was established by the USP standards themselves, which define the required properties for surgical sutures, and by the characteristics of the predicate device.

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