(68 days)
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
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Ability to adequately restrain urethral tissue | Demonstrated ability to adequately restrain urethral tissue |
| Performance under conditions in excess of normal clinical use | Demonstrated performance under conditions in excess of those encountered during normal clinical use |
| Substantial equivalence to predicate devices (K023898, K020007, K021263) | The FDA determined the device is substantially equivalent to the listed predicate devices |
- 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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.