Search Results

Plain and chromic gut surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Plain and chromic gut surgical sutures USP manufactured by R.K. Medical, L.L.C. are equivalent to plain and chromic gut surgical sutures manufactured by Davis & Geck. These sutures are absorbable, sterile surgical sutures 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 plain and chromic gut sutures are packaged in packing fluid composed of isopropanol, water, and triethanolamine. R.K. Medical plain and chromic gut surgical sutures are sterilized by gamma irradiation.

This document is a 510(k) summary for R.K. Medical's plain and chromic gut absorbable surgical sutures from 1996. It describes the device, its intended use, and claims equivalence to a predicate device.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device meets the criteria in the context of an AI/ML device.

Here's why and what's missing:

• Device Type: The device described is absorbable surgical sutures, which are a traditional medical device, not an AI/ML powered device.
• Study Type: The "study" mentioned is a comparison of physical properties (suture diameter, length, knot pull tensile strength, needle attachment strength) to USP XXIII specifications and a predicate device (Davis & Geck sutures). This is a standard engineering/materials testing study, not a clinical or AI performance study.
• Missing Information: Consequently, none of the requested fields related to AI/ML device validation (e.g., sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are present or applicable to this document.

Therefore, I cannot fulfill your request to create the table and answer the questions based on the provided text, as the text describes a conventional medical device, not an AI/ML device, and doesn't contain the relevant performance study information you're asking for.

Ask a specific question about this device

The polyester nonabsorbable surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck. The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).

Here's an analysis of the provided text regarding acceptance criteria and device performance:

This document describes a 510(k) submission for a medical device, but it fundamentally lacks the detailed information required to answer most of your detailed questions about AI device performance and studies. The device described is a Polyester Nonabsorbable Surgical Suture, which is a physical, non-AI medical device. The document predates the widespread use of AI in medical imaging and diagnostics, and thus, its content is focused on traditional medical device equivalency rather than AI performance.

Therefore, the following answers are based on the limited information provided for a non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Note: The document states the R.K. Medical sutures are "equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck" in terms of the above parameters.

Regarding the remaining questions on AI device studies:

The provided document does not contain any information about an AI-powered device, image analysis, diagnostic algorithms, or any type of study that would involve:

• AI performance metrics (sensitivity, specificity, AUC)
• Sample sizes for test or training sets for an AI model
• Data provenance for AI input data
• Experts establishing ground truth for AI analysis
• Adjudication methods for AI
• Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance
• Standalone (algorithm-only) AI performance studies
• Types of ground truth for AI (pathology, outcomes)
• Training set details for AI algorithms

Therefore, it is impossible to provide answers to questions 2 through 9 based on the given text. This document is for a physical surgical suture, not an AI device.

Ask a specific question about this device

The Polypropylene nonabsorbable surgical sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck.

The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [ phthalocyaninato (2--) | copper .

The provided text is a 510(k) summary for R. K. Medical's Polypropylene Nonabsorbable Surgical Sutures. This document aims to demonstrate the substantial equivalence of their sutures to an existing predicate device (Surgilene™ polypropylene nonabsorbable surgical sutures by Davis+Geck).

However, the information provided does not contain a description of an AI-powered device or a study involving AI. All the details pertain to a traditional medical device (surgical sutures) and its comparison to a predicate device based on physical characteristics and performance in accordance with USP standards.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves an AI device meets those criteria, nor can I provide information about sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The document discusses:

• Acceptance Criteria (implied): Meeting or exceeding USP XXIII specifications for suture diameter, suture length, knot pull tensile strength, and needle attachment strength.
• Device Performance: The R. K. Medical polypropylene sutures "meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck."
• Study: The "Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIII."

But, as stated, this is for a physical medical device, not an AI device.

Ask a specific question about this device

The nylon nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurologica1 procedures.

Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck. The nylon sutures manufactured by R. K. Medica1 and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed.

This document is a 510(k) summary for R. K. Medical L. L. C.'s Nylon Nonabsorbable Surgical Sutures. It's a regulatory submission, not a research study report, so it doesn't contain detailed information about acceptance criteria and a study in the way one would typically describe for an AI/CAD device.

However, I can extract the relevant information and structure it to answer your questions to the best of what's provided, interpreting "acceptance criteria" as meeting USP specifications and "study" as the testing performed.

Context: This device is a surgical suture, not an AI or diagnostic imaging device. Therefore, many of your questions (e.g., MRMC studies, ground truth for AI, training sets) are not applicable. I will indicate where this is the case.

Here's the breakdown of the information based on your request:

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

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified, but implied to be from testing conducted during the manufacturing process by R. K. Medical L. L. C. in Danbury, CT, USA. The testing is likely prospective, as it's a part of demonstrating compliance for a new product.

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. For a surgical suture, "ground truth" is established by adherence to defined physical specifications (USP XXIII), not by expert interpretation in a clinical context. The "ground truth" is the USP standard itself.

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

• Not Applicable. Adjudication methods are typically for subjective assessments or disagreements in clinical interpretations (e.g., in reading medical images). Here, objective physical measurements against established standards are performed.

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 product, not an AI or diagnostic imaging device.

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

• Not Applicable. This is a surgical product, not an AI algorithm. The "standalone performance" is the suture's physical properties when tested.

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

• Type of Ground Truth: USP XXIII (United States Pharmacopeia) specifications for nylon nonabsorbable surgical sutures. These are objective, quantitative standards for physical properties.

8. The sample size for the training set

• Not Applicable. This refers to machine learning. No training set is used for this type of device.

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

• Not Applicable. As no training set is used, this question is irrelevant. The "ground truth" (USP standards) is established by a pharmacopeia, based on scientific testing and consensus for medical devices.

Ask a specific question about this device

The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures .

Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck. The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) or undyed.

The provided text describes a 510(k) summary for R. K. Medical's Silk Nonabsorbable Surgical Sutures. This document aims to demonstrate the device's substantial equivalence to a predicate device (silk nonabsorbable surgical sutures manufactured by Davis + Geck).

However, the questions you've asked are typically relevant to the evaluation of AI/ML-based medical devices, where an algorithm's performance is assessed against established ground truth. The document provided describes a traditional medical device (surgical sutures) and its conformity to performance specifications rather than statistical performance metrics against a ground truth.

Therefore, many of your questions, such as those related to "acceptance criteria and reported device performance" in the context of AI, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training sets, are not applicable to this document.

Instead, the document details the acceptance criteria and the study (testing) that proves the device meets those criteria in the context of traditional medical device substantial equivalence.

Here's how to reframe the information from the document to answer what parts are applicable:

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)

• Sample Size: Not specified in the document. The document states "Testing...demonstrates that R. K. Medical silk sutures meet or exceed U. S. P. specifications." The USP (United States Pharmacopeia) outlines testing methodologies, which would include sample sizes (e.g., number of sutures to test for each parameter). However, the specific number of samples tested by R. K. Medical is not provided in this summary.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by R. K. Medical L. L. C. in Danbury, CT, U.S.A. (as per the applicant's address). The testing methods are "according to methods outlined in USP XXIII," which are internationally recognized standards.
• Retrospective or Prospective: This distinction is not applicable to the physical testing of sutures. The testing is performed on manufactured products to ensure they meet specifications.

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. For this type of device, "ground truth" is defined by the objective, measurable specifications outlined in USP XXIII. Expert interpretation is not used to establish these physical characteristics.

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

• Not Applicable. Adjudication methods are used in scenarios where human interpretation or consensus is required to establish a gold standard, typically in diagnostic imaging or clinical trials. Here, physical measurements are objective.

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 traditional medical device (sutures), 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, not an algorithm.

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

• The "ground truth" (or more accurately, the performance standard) used is the United States Pharmacopeia (USP XXIII) specifications for silk nonabsorbable surgical sutures. These are objective, quantitative criteria for suture diameter, length, tensile strength, and needle attachment.

8. The sample size for the training set

• Not Applicable. There is no "training set" for physical testing of sutures to meet specifications. This concept is relevant to machine learning where an algorithm learns from data.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary, the document demonstrates that R. K. Medical's silk sutures meet the established physical and mechanical performance standards set by USP XXIII, thereby establishing their equivalence to a predicate device. The nature of the device (surgical sutures) means that the questions posed about AI/ML device evaluation are not directly applicable.

Ask a specific question about this device