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POLYGLYCOLIC ACID 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.

POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and 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. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.

Here's an analysis of the provided text regarding the acceptance criteria and study for the POLYGLYCOLIC ACID surgical suture:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards." This implies a sample size adequate for the tests required by USP, but the specific number of units tested is not provided.
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Non-Clinical Testing," which is typically laboratory-based and not tied to specific patient populations or geographical locations. It is a retrospective study in the sense that the tests were performed and then reported, but it's not a retrospective analysis of patient data.

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

• Not applicable. The ground truth for the non-clinical testing is based on the United States Pharmacopeia (U.S.P.) standards. These are established, widely accepted objective performance metrics for medical devices, particularly sutures. No human experts are described as establishing "ground truth" for these physical and chemical tests.

4. Adjudication Method for the Test Set

• Not applicable. The evaluation relies on objective measurements against pre-defined U.S.P. standards. There is no human adjudication process described for interpreting the results of these standardized tests.

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 that involve human interpretation (e.g., radiologists reading images) and assessing the impact of AI assistance on their performance. The device in question is a surgical suture, which is a physical product, and its evaluation relies on non-clinical performance characteristics.

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 or AI system. The concept of "standalone performance" for an algorithm does not apply here. The evaluation is of the physical product's performance against established standards.

7. The Type of Ground Truth Used

• U.S.P. Standards: The ground truth for the device's performance is objective compliance with the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. These standards define the acceptable range for physical properties like diameter, tensile strength, length, and absorption characteristics.

8. The Sample Size for the Training Set

• Not applicable. The device is a surgical suture, not an AI or machine learning model. Therefore, there is no "training set" of data in the context of AI development.

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

• Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is not relevant here.

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POLYPROPYLENE is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

POLYPROPYLENE is a nonabsorbable sterile surgical monofilament suture composed of flexible thread prepared from Long-chain polyolefin polymer known as polypropylene and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYPROPYLENE meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered undyed or dyed with an FDA listed color additive, either D&C Blue No. 6, (21CFR74.3106) or D&C Blue No. 6 (21CFR74.3106) or [Phthalocyaninato(2-)] copper (21CFR74.3045). It will be offered with or without standard needles attached.

This document describes the safety and effectiveness of the POLYPROPYLENE surgical suture. Due to the nature of the device (a surgical suture), the study criteria and results are focused on physical and material properties rather than AI/software performance. Therefore, many of the requested numbered points, typically applicable to AI/ML-based medical devices, are not relevant or cannot be found in this document.

Here's the relevant information based on the provided text:

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 a distinct "test set" sample size in the context of typical AI/ML studies. Instead, it refers to non-clinical testing performed to prove conformance to U.S.P. standards. The data provenance would be from laboratory testing of the POLYPROPYLENE suture. The country of origin of the data is not explicitly stated but implies testing was conducted by or for T.CAD International, which is based in Chicago, IL, USA. The testing is prospective in the sense that it was conducted on the manufactured device to demonstrate compliance.

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

This point is not applicable. For a physical device like a surgical suture, "ground truth" is established by manufacturing specifications and adherence to recognized performance standards (U.S.P. in this case), not by expert human interpretation of data.

4. Adjudication method for the test set

This point is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of medical images or data. For physical product performance, results are based on objective measurements against engineering and material science 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 point is not applicable. The device is a surgical suture, not an AI-assisted diagnostic or decision-support system involving human readers.

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

This point is not applicable. The device is a surgical suture, not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. These are widely recognized and established performance benchmarks and specifications for medical devices.

8. The sample size for the training set

This point is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This point is not applicable. There is no training set for this type of device. The specifications and performance requirements are defined by the U.S.P. monograph.

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CATGUT 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.

CATGUT, Plain and Chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.

The acceptance criteria for the T.CAD International PLAIN/CHROMIC CATGUT surgical sutures are primarily based on conformance to established standards and similarity to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The device's acceptance was proven through non-clinical testing designed to demonstrate conformance to U.S.P. standards and substantial equivalence to the predicate device.

2. Sample Size and Data Provenance (Test Set):

• Sample Size: Not specified in the provided text for the non-clinical testing.
• Data Provenance: The testing was "Non-Clinical Testing ... conducted on the subject device." This suggests the data was generated as part of a regulatory submission process. The origin (e.g., country) of the specific data points is not mentioned, but the overall regulatory framework is the U.S. FDA. The testing is implicitly prospective as it's for a new device submission.

3. Number of Experts and Qualifications (Ground Truth for Test Set):

• This information is not applicable/not provided as there's no mention of a clinical study, expert review of images, or diagnostic interpretation. The acceptance criteria are based on physical properties and manufacturing standards, not expert interpretations of medical data.

4. Adjudication Method (Test Set):

• None specified. As the evaluation is against physical and material standards (U.S.P. requirements, etc.), expert adjudication of subjective findings is not relevant.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device is cleared based on non-clinical testing and substantial equivalence to a predicate.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a physical surgical suture, not an AI algorithm. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used:

• The "ground truth" used was based on established industry standards and specifications:
  • United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures.
  • Relevant ISO and EN standards (ISO 9002, EN 46002 & EN 552).
  • FDA Guidance documents related to suture labeling.
  • The characteristics and performance of the chosen predicate device (Plain and Chromic Absorbable Surgical Sutures of Davis & Geck - K930589).

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.

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

• Not applicable. As there is no training set for an AI model, this question is irrelevant to the provided information.

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NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.

Acceptance Criteria and Device Performance Study for NYLON Surgical Suture

This analysis focuses on the acceptance criteria and the study performed for the T.CAD International NYLON surgical suture, as presented in the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the non-clinical testing. The provenance of the data is not specified beyond being "non-clinical testing" conducted to prove conformance to U.S.P. standards. It is implied the testing was performed by or for T.CAD International. The nature of the testing (physical properties and functionality) suggests it was retrospective in the sense that the suture material was already manufactured and then tested.

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

The document does not mention the number or qualifications of experts used to establish ground truth for the test set. The ground truth for the non-clinical tests appears to be the United States Pharmacopeia (U.S.P.) standards themselves.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The testing was against pre-defined U.S.P. standards, implying a pass/fail outcome based on direct measurement compared to the standard, rather than subjective expert opinion requiring adjudication.

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

There was no MRMC comparative effectiveness study performed. Surgical sutures are not typically evaluated using MRMC studies, as their effectiveness is primarily gauged by their physical and biological performance rather than interpretative tasks. Clinical testing was explicitly stated as "Not available at the present time."

6. Standalone Performance Study (Algorithm Only)

This question is not applicable as the device is a physical surgical suture, not an algorithm or software. Therefore, there was no "algorithm only" performance study.

7. Type of Ground Truth Used

The primary ground truth used for the device's acceptance was United States Pharmacopeia (U.S.P.) Standards. This represents established regulatory and performance benchmarks for surgical sutures. The comparison to predicate devices also implies a ground truth established by the long-standing safe and effective use of those predicate devices.

8. Sample Size for the Training Set

This question is not applicable. Surgical sutures, being physical devices, do not typically involve "training sets" in the context of machine learning or algorithms. The manufacturing process is controlled to produce sutures that consistently meet specifications.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. The production of surgical sutures relies on established manufacturing processes and quality control to ensure consistency, rather than a "training set" with established ground truth in the AI sense.

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SILK is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

SILK is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.

SILK is offered braided, uncoated or silicon coated, undyed or dyed with an FDA listed color additive, D&C Blue No. 9 (21CFR74.1109), or Logwood extract, C.I. Natural Black 1 (21CFR74.1410). SILK meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures.

This is a 510(k) summary for a medical device called SILK, which is a nonabsorbable surgical suture. The provided text describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. It is important to note that this document is for a surgical suture, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs associated with AI performance (like accuracy, sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this submission.

The "acceptance criteria" for a surgical suture like SILK are related to its physical properties and biocompatibility, typically established by adherence to recognized standards like the United States Pharmacopeia (USP). The "study" proving it meets these criteria is non-clinical testing.

Here's the information extracted and interpreted in the context of a surgical suture, addressing your points where applicable:

Acceptance Criteria and Device Performance (for a Surgical Suture)

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

For a surgical suture, the "acceptance criteria" are compliance with established industry standards and functional requirements compared to a predicate device. The "device performance" is simply meeting these standards and demonstrating substantial equivalence.

Study Details (Relevant to a Surgical Suture)

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 distinct "test set" in the context of AI. For a surgical suture, non-clinical testing involves mechanical and material tests. The number of samples for these tests would follow USP and ISO testing protocols, but the specific quantity is not provided.
• Data Provenance: Not applicable in the AI sense. This is non-clinical performance and physical property testing of manufactured suture samples.

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)

• Number of Experts & Qualifications: Not applicable. Ground truth for a suture is established by objective physical and chemical testing against recognized standards (e.g., USP monographs for tensile strength, diameter, sterility, material composition). It doesn't rely on expert consensus in the same way an AI diagnostic image interpretation would.

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

• Adjudication Method: Not applicable. Performance is measured objectively against standards, not through human interpretation requiring 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

• MRMC Study: No. This is a surgical suture, not an AI diagnostic device. MRMC studies are specific to evaluating AI's impact on human diagnostic performance.

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

• Standalone Performance: Not applicable. This is a physical device, a suture, not an algorithm. The "standalone performance" is its physical and chemical properties as tested.

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

• Type of Ground Truth: Established by recognized physical and chemical standards and specifications from regulatory bodies (e.g., United States Pharmacopeia (USP)) and international standards organizations (e.g., ISO, EN). This includes specifications for material composition, dimensions, tensile strength, sterility, and biocompatibility.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for a surgical suture's regulatory submission outside of potentially manufacturing process validation data, which is not described here in detail.

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

• Ground Truth for Training Set Establishment: Not applicable as there is no training set for this type of device.

Summary for this specific device (SILK Surgical Suture):

The "acceptance criteria" are adherence to the U.S.P. standards for nonabsorbable silk surgical sutures, ISO 9002, EN 46002, and EN 552 Standards, and substantial equivalence to the predicate device (Davis & Geck Silk Non-Absorbable Surgical Sutures, K930590) in terms of material, characteristics, intended use, manufacturing, and labeling.

The "study that proves the device meets the acceptance criteria" is Non-Clinical Testing. This testing focused on:

• Conformance to U.S.P. standards.
• Physical properties and functionality testing to assure safety and effectiveness.
• Demonstrating substantial equivalence to the predicate device.

No clinical testing was available or required for this 510(k) submission, indicating that the non-clinical data was deemed sufficient for establishing substantial equivalence for this Class II surgical suture.

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POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.

This document describes the Polyester Surgical Suture, a nonabsorbable, sterile suture composed of Poly (ethylene terephthalate), intended for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tri-Cron® Non-Absorbable Polyester Surgical Suture and Ethibond® Nonabsorbable Polyester Surgical Suture) through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POLYESTER surgical suture are primarily based on conformance to United States Pharmacopeia (U.S.P.) standards and demonstrating substantial equivalence to the predicate devices. The document explicitly states that the device meets these requirements.

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

The document states: "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device."

• Sample Size: The specific sample sizes for the non-clinical tests are not provided in this summary.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's non-clinical testing for a device intended for U.S. market (submitted to FDA), it's highly likely the testing was conducted in a controlled laboratory environment, potentially in the U.S. or by a compliant international facility.

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

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through expert consensus on qualitative assessments.

4. Adjudication Method for the Test Set

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through human adjudication of qualitative data.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical testing.

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

This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI model.

7. The Type of Ground Truth Used

The ground truth used for evaluating the POLYESTER surgical suture is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. This involves objective physical and functional property measurements (e.g., suture diameter, length, knot pull tensile strength, needle attachment strength).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

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

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

In summary, the Polyester Surgical Suture demonstrated conformance to U.S.P. standards and substantial equivalence to predicate devices through non-clinical laboratory testing of its physical and functional properties. No clinical studies, expert-based ground truth, or AI-related evaluations were performed or required for this 510(k) submission.

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