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Omnisure™ Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Omnisure™ Urethral Sling is a surgical mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device. The device is supplied sterile.

The provided text describes a 510(k) premarket notification for the "Omnisure™ Urethral Sling" by Mpathy Medical Devices, Ltd. This submission is for a surgical mesh, which is a physical device, not a digital health product or an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance metrics like sensitivity, specificity, or AUC, as commonly applied to AI/ML devices, is not directly applicable here.

Instead, for a physical medical device like a surgical mesh, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, technological characteristics (materials, design, fundamental scientific technology), and performs comparably in terms of safety and effectiveness.

Here's how the provided information addresses your request, framed within the context of a physical medical device:

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

The submission does not explicitly list "acceptance criteria" in the quantitative sense of an AI/ML device. Instead, the core "acceptance criterion" for a 510(k) is substantial equivalence to a legally marketed predicate device.

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

The provided documents do not detail a "test set" in the context of a clinical performance study with a specific sample size. For a 510(k) of this nature, clinical studies with detailed sample sizes and data provenance are often not required if substantial equivalence can be demonstrated through other means (e.g., comparison of materials, design, and non-clinical testing). The key testing mentioned is "biocompatibility and mechanical testing" which are laboratory-based and do not typically involve human "test sets" with specified provenance.

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)

This is not applicable to this 510(k) submission. "Ground truth" in the context of AI/ML evaluation (established by experts) is not relevant for demonstrating substantial equivalence of a physical surgical mesh.

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

This is not applicable to this 510(k) submission as there is no mention of a "test set" requiring expert 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

This is not applicable. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human interpretation, often with AI assistance. This submission is for a surgical mesh, not a diagnostic device.

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

This is not applicable. The device is a physical surgical mesh, not an algorithm.

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

For this type of device, the "ground truth" for demonstrating safety and effectiveness is typically established through:

• Predicate device's safety and effectiveness history: The predicate devices (Minitape® Extra Urethral Sling, SPARC Sling System, TVT) have established safety and effectiveness through their prior market clearance and clinical use.
• Non-clinical testing: "biocompatibility and mechanical testing" for the Omnisure™ device itself, demonstrating that its properties are comparable to the predicate.
• Clinical experience (if any) with similar materials/designs: Implied by the substantial equivalence argument, leveraging existing knowledge of surgical meshes.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

In summary: The provided 510(k) notification for the Omnisure™ Urethral Sling demonstrates that it meets the "acceptance criteria" (i.e., criteria for substantial equivalence to a predicate device) by asserting that it has the same intended use, general design, material, and fundamental scientific technology as the predicate device (Minitape® Extra Urethral Sling, K073647). This claim is supported by the fact that the components of the Omnisure™ device have undergone biocompatibility and mechanical testing to confirm their equivalence to the predicate. The FDA's issuance of the substantial equivalence letter (K092203) signifies that the device has met these regulatory "acceptance criteria."

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Minitape® Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The subject device is a surgical mesh. The proprietary mesh is supplied along with ancillary tools for placement of the device (convenience kit). The kit consists of: Minitape Urethral Sling (mesh) intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency; Disposable needle introducers, optionally used to aid in placement of the Minitape mesh; Polydioxanone absorbable sutures (CP Medical; Portland, OR), used to secure the mesh in place; Polypropylene suture bolsters (Ethicon Inc.; Sommerville, NJ), optionally used to aid in tightening ("snugging") the mesh following surgical placement.

This 510(k) summary (K091180) describes the Minitape Urethral Sling. However, the provided document does not contain acceptance criteria for device performance nor a detailed study that proves the device meets such criteria in terms of clinical effectiveness or specific quantitative measures.

Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily mentioning "in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use." This is a qualitative statement about the type of testing performed, not a report of results against specific performance metrics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to address the points based only on the provided information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The document mentions "in-vitro and in-vivo testing," but does not give details on the origin, nature (retrospective/prospective), or location of data collection.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The device is a surgical mesh, and the testing described is related to its mechanical properties and biological interaction, not to image interpretation or AI assistance for human readers.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study or AI component is mentioned.

6. Standalone (algorithm only without human-in-the-loop performance) study

• Standalone Study: Not applicable. This device is a surgical mesh; there is no algorithm or AI component described that would have a standalone performance. The testing mentioned (in-vitro, in-vivo) refers to the physical device itself.

7. Type of ground truth used

• Type of Ground Truth: Not explicitly stated in the context of specific performance metrics or clinical outcomes. The testing broadly "demonstrate[s] the ability of the device to adequately restrain urethral tissue." For "in-vivo" testing, this implies observation of physiological outcomes or biomechanical responses, but the method of establishing a definitive "ground truth" for success or adequate restraint is not detailed. For "in-vitro" testing, ground truth would likely be based on engineering measurements (e.g., tensile strength, elasticity).

8. Sample size for the training set

• Sample Size (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set. The device is a physical surgical implant.

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

• Ground Truth Establishment (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set.

Summary of Missing Information:

The provided 510(k) summary document for the Minitape Urethral Sling primarily focuses on establishing substantial equivalence to predicate devices and generally describing the types of testing performed. It explicitly states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use."

However, it does not provide any specific quantitative acceptance criteria or detailed results from these tests, nor does it describe specific study methodologies (like sample sizes, expert involvement, or adjudication) that would be typically found for performance studies. This is often the case in 510(k) summaries where the detailed test reports are part of the full submission but not included in this public summary.

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The Minitape* Extra Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency

The subject device is a totally disposable mesh tape intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a monocomponent polypropylene tape with integral fixation zones on either side of a central sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.

The provided text is a 510(k) summary for the Minitape* Extra Urethral Sling, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. While it mentions "in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue," it does not provide detailed information about acceptance criteria or specific study results in the format requested.

Here's why and what information is missing:

• 510(k) Summaries vs. Detailed Study Reports: A 510(k) summary is a high-level overview. It typically asserts that a device meets performance requirements based on testing but does not usually include the granular details of test protocols, acceptance criteria, sample sizes, or specific performance metrics in the way a full study report or journal publication would.
• Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive, detailed clinical trials with specified acceptance criteria as might be seen for a PMA (Premarket Approval) application.

Therefore, much of the requested information is not present in the provided text.

Based on the available text, here's what can be inferred or explicitly stated:

1. Table of acceptance criteria and the reported device performance

• Note: The specific, quantitative acceptance criteria are not provided in this summary. The performance is broadly stated as "adequately restrain urethral tissue" and "under conditions in excess of those encountered during normal clinical use." Substantial equivalence is the overarching acceptance criterion for a 510(k).

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 for in-vitro or in-vivo testing.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

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

• This information is not applicable and not provided. The testing described (in-vitro, in-vivo) would typically involve laboratory or animal models, not human experts establishing ground truth in the context of diagnoses or classifications.

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

• Not applicable and not provided. This typically relates to expert consensus in medical image analysis or similar diagnostic studies, which is not the nature of the testing described for this device.

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 and not provided. The device is a surgical sling, not an AI diagnostic tool.

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

• Not applicable and not provided. The device is a physical surgical implant, not an algorithm.

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

• For the "in-vitro" testing, ground truth would likely be defined by engineering specifications, material properties, and mechanical performance measurements against established standards.
• For the "in-vivo" testing, ground truth would likely be based on physiological or histological assessments in animal models (e.g., tissue response, integration, stability).
• Specifics are not provided.

8. The sample size for the training set

• Not applicable and not provided. The device testing described involves in-vitro and in-vivo (likely animal) studies, not a "training set" in the context of machine learning or AI.

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

• Not applicable. (See point 8)

Summary of what the document does tell us about the study:

• Study Type: The device was subjected to "in-vitro and in-vivo testing."
• Purpose of Study: To "demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use."
• Outcome: The FDA determined the device to be "substantially equivalent" to predicate devices, implying that the testing supported this equivalence claim. However, the specific data that led to this conclusion is not in the summary.

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The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The subject device is a totally disposable tape mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.

The provided text is a 510(k) summary for the "Modified Minitape* Urethral Sling" and primarily discusses regulatory information, device description, and indications for use. It briefly mentions "in-vitro and in-vivo testing" that "demonstrate the ability of the device to adequately restrain urethral tissue," but it does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert qualifications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document states that testing was performed, but it does not describe the specific study (or studies), their methodologies, or their results in a way that allows for the extraction of the requested information.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative or qualitative acceptance criteria for device performance.
• Sample sizes (test set), data provenance: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth: Not mentioned, although for a physical device like a sling, "ground truth" would likely relate to clinical outcomes, physiological measurements, or imaging post-implantation, none of which are detailed here.
• Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable as this is a physical medical device, not an AI algorithm.

The core of the provided document is the 510(k) regulatory submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report.

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MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.

Here's an analysis of the provided text regarding the Minimesh® polypropylene mesh, focusing on acceptance criteria and study details.

Based on the provided documents (K053361), this submission is a 510(k) for a modification to an existing device (K041632 Minimesh® polypropylene mesh). The nature of the modification is not explicitly detailed in the provided excerpts, but the summary primarily focuses on the device description, indications for use, and stability testing.

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not describe an acceptance criteria or a study with specific performance metrics for the device's clinical efficacy or diagnostic accuracy. This is typical for a 510(k) submission for a surgical mesh, especially a modification, where the primary focus is on demonstrating substantial equivalence to a predicate device through material properties, manufacturing processes, and safety, rather than a clinical performance study with defined acceptance criteria for outcomes like diagnostic accuracy.

The "TESTING" section almost exclusively discusses stability studies and not clinical performance.

Here's the information extracted / inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• None provided for a clinical or performance study with a test set of patients/cases. The stability studies would have involved material samples, but the sample size is not specified.
• Data Provenance: Not applicable for a clinical test set. The stability studies would be лабораторные (lab-based) rather than human data.

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

• Not applicable. No clinical test set requiring expert ground truth was described.

4. Adjudication method for the test set

• Not applicable. No clinical test set requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a surgical mesh device, not an AI/imaging diagnostic device. An MRMC study is not relevant to this type of medical device submission.

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

• Not applicable. This is a surgical mesh device, not an algorithm.

7. The type of ground truth used

• For the stability studies, the "ground truth" would be laboratory measurements (e.g., tensile strength, degradation rates) against established specifications for material properties to determine shelf life.
• For the overall device, substantial equivalence relies on comparison to a predicate device (K041632) which would have already established its safety and efficacy for the intended use.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this surgical mesh device.

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

• Not applicable.

Summary of Device and Evidence Type:

The submission for Minimesh® polypropylene mesh (K053361) is a 510(k) for a modification. The evidence presented in these excerpts focuses on:

• Substantial Equivalence: By describing the device properties and indications for use as similar to a legally marketed predicate device (K041632).
• Product Stability/Shelf-Life: Via accelerated and real-time stability studies conducted to support a three-year expiration date. These are lab-based technical tests, not clinical performance studies.

There are no clinical performance studies with specific patient-oriented acceptance criteria or detailed methodologies involving a test set of patients/cases, human readers, or AI algorithms described in the provided documents.

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MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.

Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.

It maintains excellent isotropic properties arising from its knitted construction.

Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body.

The device is supplied sterile.

The provided text describes the 510(k) Notification for Mpathy Medical Devices, Ltd.'s Minimesh® polypropylene mesh, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device.

This document pertains to a traditional medical device (surgical mesh) and focuses on substantial equivalence to predicate devices, safety testing (biocompatibility per ISO 10993), and compliance with FDA guidance for surgical mesh.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input. The categories requested, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size and ground truth establishment," are all relevant to the evaluation of AI/ML-driven medical devices and are not discussed in this 510(k) for a physical surgical mesh.

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