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OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

The provided text is an FDA 510(k) Pre-Market Notification for a medical device called OPTIME® R, which is an absorbable surgical suture. The document primarily focuses on establishing substantial equivalence to a predicate device (Safil Quick Aesculap, K031286) based on technological characteristics and performance testing.

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

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

The document states that the OPTIME® R suture was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. The following tests and their corresponding USP standards are mentioned:

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ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.

ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.

ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

The provided document is a 510(k) summary for a surgical suture device (ADVANTIME Absorbable Suture) and does not describe an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, and performance measures (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) related to AI/ML devices are not applicable.

The document discusses the substantial equivalence of the ADVANTIME Absorbable Suture to a predicate device based on physical and biological performance testing for a medical device that is not an AI/ML device.

Here's the information that is relevant from the provided text regarding this medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

The device was subjected to the requirements of the United States Pharmacopeia (U.S.P.) monograph for Synthetic Absorbable Sutures.

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device study. Performance was evaluated based on physical and biological tests according to USP standards and ISO 10993-1.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device. Ground truth for physical properties is defined by USP standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device. Performance is objectively measured 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 as 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 as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical characteristics, the ground truth is defined by the United States Pharmacopeia (USP) standards and test methodologies. For biological evaluation, the ground truth is established by standardized testing protocols detailed in ISO 10993-1.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

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The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The UNIRING® consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available scparately to properly size the annulus.

I am sorry, but based on the provided document, there is no acceptance criteria table or specific study described that proves the device meets particular acceptance criteria.

The document is a 510(k) Summary for the UNIRING® Annuloplasty Ring. Its purpose is to demonstrate substantial equivalence to previously cleared predicate devices, not to present detailed performance data against specific, quantitative acceptance criteria.

Here's what the document does state regarding performance:

• Non-clinical laboratory testing:
  • Demonstrated compliance with USP Monographs and EP Monographs for Absorbable surgical sutures.
  • Biocompatibility testing: Supported that materials are "non-toxic, non-hemolytic, and non-pyrogenic." Conducted under Good Laboratory Practices per 21 CFR Part 58.
  • Mechanical Integrity testing: Specifically, suture retention testing "demonstrated that the design provided for a more than adequate sure reterior force as compared to the predicate device."
  • Overall, testing "demonstrated that the UNIRING® is substantially equivalent to the predicate device for repair of the mitrial or tricuspid valve."

However, the document does not provide:

• A table of explicit acceptance criteria (e.g., "suture retention force must exceed X Newtons").
• The raw results or statistical analysis from any of these tests.
• Details on sample sizes for these tests.
• Information that would allow answering questions 2-9 from your prompt (e.g., data provenance, expert ground truth, MRMC studies, standalone algorithm performance, training data, etc.) because these types of studies are not mentioned or typically required for a 510(k) substantial equivalence determination based on non-clinical comparative performance.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving their fulfillment. The document focuses on showing substantial equivalence through non-clinical testing and comparison to predicate devices, rather than establishing and meeting specific performance endpoints with detailed clinical or large-scale testing data.

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PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.

PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.

The provided text describes the submission of a 510(k) premarket notification for a new surgical suture device named PREMIO®. The purpose of this submission is to demonstrate that PREMIO® is substantially equivalent to a legally marketed predicate device, PRONOVA™. The document focuses on comparing the new device to the predicate device, particularly regarding their technological characteristics and intended use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that non-clinical laboratory testing was performed. However, it does not specify the sample size used for this testing. The data provenance is also not detailed beyond mentioning "non-clinical laboratory testing." It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on laboratory testing against established pharmacopoeia standards (USP and EP) rather than expert review of cases or outcomes.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a test set requiring adjudication in the context of human review, no adjudication method is described.

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

No MRMC comparative effectiveness study was done or mentioned. The submission focuses on demonstrating substantial equivalence through technological and performance comparisons against established standards and a predicate device, not on assessing human reader improvement with or without AI assistance.

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

This concept is not applicable to the device being described. PREMIO® is a physical surgical suture, not a software algorithm or AI-powered system designed for standalone performance or human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used for evaluating PREMIO® appears to be the established standards and specifications outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. The biocompatibility of the raw material is also cited as "proven," likely referring to existing literature or prior regulatory approvals for the material.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. PREMIO® is a physical medical device, not a machine learning model that requires a training set. The evaluation is based on laboratory testing and comparison to a predicate device and monograph standards.

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

As there is no training set, this question is not applicable.

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The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.

The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane. CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use. CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.

The provided text describes a 510(k) summary for the CARDIOFLON® and CARDIOXYL® sutures. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria. Therefore, most of the requested information (related to a clinical study, sample sizes, ground truth establishment, expert involvement, and MRMC studies) is not applicable to this type of regulatory submission.

However, I can extract the relevant information from the document regarding acceptance criteria and performance as pertaining to the regulatory submission for substantial equivalence.

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

Study that proves the device meets the acceptance criteria:

The document states that "Non-clinical laboratory testing was performed demonstrating that the devices complied with the USP Monographs and with the EP Monographs for non-absorbable surgical sutures." This implies that a series of in-vitro and/or bench tests were conducted to verify the physical, chemical, and mechanical properties of the sutures against the established standards.

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

• Sample size: Not specified. As this is non-clinical laboratory testing against pharmacopoeial monographs, specific sample sizes for clinical testing are not relevant here. The pharmacopoeias themselves would define the sample sizes for the specific tests required.
• Data provenance: Not specified, but implied to be from internal lab testing conducted by Peters Surgical, likely in France (country of origin of the company). This would be retrospective in the sense that the testing was performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for clinical studies (e.g., expert consensus on medical images) is not relevant for demonstrating compliance with pharmacopoeial monographs. The "ground truth" here is the established specifications and methods within the USP and EP.

4. Adjudication method for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies involving multiple reviewers. The testing against USP/EP monographs is 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 medical device submission for surgical sutures, not an AI-powered diagnostic device.

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

7. The type of ground truth used:
The "ground truth" for the performance data mentioned is the specifications and testing methodologies detailed within the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) Monographs for nonabsorbable surgical sutures.

8. The sample size for the training set:
Not applicable. There is no "training set" in the context of this type of regulatory submission for a physical medical device.

9. How the ground truth for the training set was established:
Not applicable. See point 8.

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The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.

OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.

The provided document is a 510(k) premarket notification for a medical device (surgical sutures) and does not contain information regarding studies with acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Coated VICRYL™ (POLYGLACTIN 910) Suture) through non-clinical laboratory testing.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The device's performance was evaluated against the requirements of the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures.
• Reported Device Performance: The document states, "Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures."

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

• Sample Size: Not specified. The document only mentions "non-clinical laboratory testing" without detailing the number of units tested.
• Data Provenance: Not explicitly stated beyond "non-clinical laboratory testing."

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

• Not applicable/Not provided. Ground truth in this context would likely refer to established pharmacopoeia standards, not human expert consensus.

4. Adjudication method for the test set:

• Not applicable/Not provided. Compliance with pharmacopoeia standards typically involves laboratory testing against defined physical and chemical properties, not human 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 document is for a physical medical device (sutures), not an AI/software device involving human readers or AI assistance.

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 (sutures), not an AI/software algorithm.

7. The type of ground truth used:

• Ground Truth: Pharmacopoeia standards (United States Pharmacopoeia (USP) Monographs and European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures).

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that requires a training set. The "new device" is compared to a "predicate device" and its performance against pharmacopoeia standards is established through non-clinical testing.

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

• Not applicable. As above, this is not an AI/software device.

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COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.

COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.

The provided text describes a 510(k) summary for a new surgical suture called COROLENE®. The submission aims to demonstrate substantial equivalence to a predicate device, PROLENE™.

Here's an analysis of the acceptance criteria and study information:

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 "test set" in the context of clinical or performance testing on a specific sample size of devices, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). The performance data cited are related to compliance with established industry standards (USP and EP monographs).

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

Not applicable. The ground truth for this type of device (surgical suture) is established through adherence to recognized pharmacopoeia standards (USP, EP) rather than expert consensus on a test set in the way one might evaluate an AI diagnostic tool.

4. Adjudication method for the test set

Not applicable, as there isn't a "test set" requiring adjudication by experts.

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 device is a surgical suture, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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.

7. The type of ground truth used

The "ground truth" for this device's performance is its conformance to the specifications and requirements outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. This includes material properties, sterility, dimensions, tensile strength, and biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical surgical suture.

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

Not applicable, as there is no training set for this type of device.

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