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Anchorsure is indicated for attaching suture to ligaments of the pelvic floor.

Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.

The ANCHORSURE device is a suture kit used for attaching sutures to ligaments of the pelvic floor. The submission evaluates the device against its predicate, the GYNECARE PROLENE FASTENER SYSTEM (K042603).

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ANCHORSURE device are based on demonstrating that it meets established performance requirements and standards. The reported device performance is that it "meets the established performance requirements and standards."

Note: The document states that "Results of verification testing indicate that the product meets the established performance requirements and standards." Specific numerical acceptance values are not provided in this summary but are implied by adherence to standards like USP.

Study Details

Based on the provided information, the studies conducted are performance tests primarily focused on the physical and material properties of the device, rather than a clinical study evaluating human outcomes or an AI-driven analysis.

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

• Test Set Sample Size: Not explicitly stated for each test. The sample sizes would be determined by the specific protocols for each performance test (e.g., number of sutures tested for strength, number of anchors for pullout strength).
• Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer, Neomedic International, S.L., located in Spain, or by a contract testing facility. This is an in vitro evaluation, not involving human subjects or real-world clinical data. Therefore, the concept of "country of origin of the data" in a clinical sense, or "retrospective/prospective," is not directly applicable.

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

• Not applicable. For these performance tests, "ground truth" is established by adherence to recognized national and international standards and test methods (e.g., USP standards for materials and mechanical properties, ISO standards for sterilization and biocompatibility). The expertise lies in performing the tests according to these standards and interpreting the results against the specified criteria. There isn't a "ground truth" established by human experts in the context of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image-based evaluations where multiple human readers assess a case. For physical performance tests, the results are typically quantitative measurements that are compared directly to pre-defined numerical or qualitative acceptance criteria.

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

• No. An MRMC study is not relevant here as this is a physical device undergoing performance testing, not a diagnostic or AI-assisted system that would involve human readers interpreting cases.

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

• No. This is not an AI-enabled device or an algorithm. It's a physical surgical tool.

7. The Type of Ground Truth Used:

• For sterilization, packaging, and mechanical tests, the ground truth is established by adherence to industry-recognized standards and test methods (e.g., USP, ISO).
• For biocompatibility, the ground truth was "biocompatibility testing completed on the Surelift Prolapse System (K102815) was used to support the biocompatibility of Anchorsure." This means the biocompatibility of the materials used in Anchorsure was confirmed by previous, cleared testing of a similar device using the same materials, ensuring compliance with relevant biocompatibility standards.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning model or an AI algorithm.

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

• Not applicable. (See point 8).

In summary, the ANCHORSURE device underwent rigorous laboratory-based performance testing against established industry standards for sterilization, packaging, biocompatibility, and mechanical properties. The aim was to demonstrate that the device's physical and material characteristics meet the necessary safety and effectiveness requirements, rather than evaluating its performance in a clinical setting with human readers or AI algorithms.

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KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.

KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. KIM (Knotless Incontinence Mesh) is composed by a monofilament polypropylene mesh sling and two passers used to pass the sling through the obturator foramens. Polypropylene monofilament traction threads are fixed at each end of the mesh to facilitate the attachment of the passers to the mesh. The passers are used to deliver the sling via the trans-obturator "out-inside" approach. The traction threads are removed after placement of the sling. When placing the mesh, the sling can be adjusted by the surgeon to leave the mesh flat under the urethra, at the proper tension providing extra support to the urethra.

Here's an analysis of the provided 510(k) summary regarding the KIM (Knotless Incontinence Mesh), focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary acts as a declaration of substantial equivalence rather than a detailed report of specific quantitative acceptance criteria or performance metrics beyond the material properties. The acceptance criteria are implicit in meeting established performance requirements and standards for medical devices of this type. The "reported device performance" section primarily lists the types of tests performed and broadly states that the product meets the requirements.

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

The provided document does not specify sample sizes for the test sets used in any of the performance tests (sterilization, packaging, biocompatibility, mechanical tests).

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically part of a detailed test report, not a 510(k) summary.

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

This information is not applicable and not provided in the context of this 510(k) submission. This type of submission relies on engineering and laboratory testing against established standards for material and device performance, not on expert consensus for "ground truth" as you would find in an AI/diagnostic imaging study.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints, not for the physical and material testing described 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

An MRMC comparative effectiveness study was not performed or mentioned. This is a medical device approval for a physical surgical mesh, not an AI software device that assists human readers.

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

A standalone performance study of an algorithm was not performed. This is a physical medical device.

7. The Type of Ground Truth Used

For the physical and material tests, the "ground truth" is established by:

• Established industry standards and regulatory guidelines: These define acceptable ranges for properties like tensile strength, pore size, sterility, and biocompatibility.
• Predicate device characteristics: The properties of the predicate devices implicitly set a benchmark for acceptable performance. The summary states that the technological characteristics of the KIM mesh are substantially equivalent to the predicate devices.
• Laboratory test procedures: These procedures define how the "truth" (e.g., actual tensile strength, actual pore size) is measured and quantified.

8. The Sample Size for the Training Set

This is not applicable and not provided. There is no "training set" in the context of this device. This is not an AI/machine learning submission.

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

This is not applicable and not provided, as there is no training set for this type of device submission.

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The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens.

The mesh has six fixation points (two posterior fixation points and four arms):

• Two posterior fixation points that are fixed to the sacrospinose ligaments.
• Two middle arms that are passed through the arcus tendineus.
• Two anterior arms that are passed through the anterior part of the obturator foramen.

When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.

Here's a breakdown of the acceptance criteria and study information for the Surelift Prolapse System, based on the provided 510(k) amendment:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical safety and effectiveness through a dedicated clinical performance study with detailed acceptance criteria measured against clinical outcomes. The "performance tests" listed are primarily related to material properties, sterilization, and biocompatibility, ensuring the device meets established standards for medical devices of its type.

Study that Proves Device Meets Acceptance Criteria:

The document describes a series of "Performance tests" that were conducted to demonstrate the device meets established performance requirements and standards.

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

The document does not specify sample sizes for any of the individual performance tests (e.g., number of meshes tested for tensile strength, number of anchors for pullout strength). It also doesn't mention data provenance regarding country of origin or whether the data was retrospective or prospective. These types of tests are typically conducted in a laboratory setting using manufactured samples.

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

This information is not applicable in this context. The "performance tests" relate to physical, chemical, and biological properties, not clinical diagnostic accuracy or interpretation requiring expert consensus on a test set. The ground truth for these tests is based on objective measurements and adherence to recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a surgical implant (Surelift Prolapse System), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

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

No, a standalone performance study in the context of an algorithm's performance was not done. This device is a surgical mesh kit, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests described is based on:

• Objective measurements: For physical properties like dimensions, tensile strength, pore size, etc.
• Established standards and regulations: For sterilization (e.g., SAL), biocompatibility (e.g., ISO standards for cytotoxicity, irritation), and other performance requirements.

8. Sample Size for the Training Set:

This information is not applicable. The device is a surgical mesh kit, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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