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Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.

This document is a 510(k) summary for the Ophira™ Mini Sling System, a medical device for treating female stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for the new device. Therefore, the information requested regarding acceptance criteria and performance studies is not fully present in the provided text.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Ophira™ Mini Sling System itself. Instead, it relies on demonstrating substantial equivalence to a 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 text does not contain information about a test set sample size or data provenance for a performance study of the Ophira™ Mini Sling System. The 510(k) summary focuses on substantial equivalence based on material, design, and intended use comparison to a predicate device, rather than patient performance data for the new device.

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 information is not provided in the document as there is no described clinical performance study or test set with ground truth established by experts.

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

This information is not provided in the document as there is no described clinical performance study 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:

This is not applicable. The device is a surgical sling, not an AI-assisted diagnostic tool or a device where "human readers" would be involved in interpreting results.

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 implant, not an algorithm.

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

As no performance study with a test set is described, no ground truth is mentioned for the Ophira™ Mini Sling System. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the legally marketed predicate device, the MiniArc Precise™ Single-Incision Sling (K100807), and the demonstration that the new device is substantially equivalent in its characteristics.

8. The sample size for the training set:

This is not applicable. The device is a physical surgical implant and not an AI/machine learning model that would require a training set.

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

This is not applicable as there is no training set for a machine learning model.

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SAFYRE VS and SAFYRE T are to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

PROMEDON's Slings, SAFYRE VS and SAFYRE T, are manufactured with biocompatible silicone elastomers and polypropylene. Each sling is a permanent implant and is offered as a single use sterile product. Safyre consists of a monofilament polypropylene mesh between two silicone columns that are made of multiple coneshaped soft tissue anchors. These units are the basis of the self anchoring system. The polypropylene mesh lies on the mid-urethra and the interconnective tissue grows among its pores, between the vaginal flap and the urethra, which leads to integration of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia or the obturator muscle. This self . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.

SAFYRE VS consists of a sling and a pair of single-use surgical instruments to facilitate its vaginal or suprapubic implantation ; while SAFYRE T is made up of the same sling, only varying in length with respect to the model VS, and a needle intended for the transobturator technique. Both are supplied with the surgical instruments to aid implantation.

The provided text describes a 510(k) premarket notification for the SAFYRE Sling System (SAFYRE VS and SAFYRE T) and not a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies with detailed measures like those outlined in the prompt. The "performance testing" mentioned in the document refers to bench testing and biocompatibility testing, which are fundamental safety and efficacy tests for medical devices, but not the type of clinical performance study with AI-specific metrics that the prompt is asking for.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text because it describes a different type of regulatory submission.

Here's an analysis based on the information available in the text:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics (e.g., accuracy, sensitivity). The "acceptance criteria" for a 510(k) are typically focused on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/efficacy.
   • Reported Device Performance: The document states "Bench testing and biocompatibility testing was performed on the SAFYRE VS and SAFYRE T." However, no specific performance results (e.g., tensile strength values, biocompatibility study results) are provided in this summary.

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

   • Not applicable/Not mentioned. The document refers to "bench testing" and "biocompatibility testing," which are not typically associated with clinical test sets in the way implied by the prompt (i.e., for evaluating diagnostic accuracy).

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/Not mentioned. This information would be relevant for a clinical performance study involving expert assessment, which is not described here.

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

   • Not applicable/Not mentioned.

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/Not mentioned. This device (surgical mesh) is not an AI-powered diagnostic tool, so such a study would not be relevant.

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

   • Not applicable/Not mentioned.

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

   • Not applicable/Not mentioned in the context of clinical performance evaluation. For bench testing, the "ground truth" would be engineering specifications or scientific standards.

8. The sample size for the training set:

   • Not applicable/Not mentioned. This device is not an AI model requiring a training set in the sense implied.

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

   • Not applicable/Not mentioned.

Summary from the provided text:

The document is a 510(k) summary for SAFYRE VS and SAFYRE T surgical mesh, demonstrating substantial equivalence to a predicate device (SAFYRE Sling System - K020007). The performance testing mentioned is "Bench testing and biocompatibility testing," aimed at ensuring the device's safety and fundamental functional properties, rather than clinical efficacy or diagnostic accuracy as might be evaluated for an AI medical device. No specific clinical study or performance data fitting the prompt's criteria (e.g., accuracy, sensitivity, expert review, AI integration) is present.

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Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

PROMEDON's Sling, SAFYRE, is manufactured with biocompatible silicone elastomers and polypropylene. It is a permanent implant and is offered as a single use sterile product. Safyre consists of a pierced polypropylene mesh between two silicone columns that are made of multiple cone-shaped soft tissue anchors. The e units are the basis of the self anchoring system. The polypropylene shilles on the mid-urethra and the interconnective tissue grows among me the perforations between the vaginal flap and the urethra, which leads to internation of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia. This self anchoring is enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.

The provided text is a 510(k) Summary for the SAFYRE Sling, which is a premarket notification for a medical device. This document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "Bench testing and biocompatibility testing was performed on the SAFYRE Sling." (Page 2, Section 7. Performance Testing). However, no details about the results, acceptance criteria, or specific study designs for these tests are provided.
• The FDA letter (Pages 3-4) confirms that the device was found "substantially equivalent" to predicate devices, which is a regulatory determination based on comparison to existing legally marketed devices, not typically on a new performance study proving acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on establishing substantial equivalence to predicate devices, not on presenting detailed performance study results against specific acceptance criteria.

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