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The IMPROVE BLADDER SUPPORT is an over-the-counter device intended for the temporary management of stress urinary incontinence (SUI) in women.

The IMPROVE BLADDER SUPPORT device is a single use vaginal pessary, inserted into the vagina, by the user herself, using an applicator similar to a menstrual tampon applicator. The device comprises of a flexible silicone rubber core, covered with a non-woven mesh, and a removal string. Once inserted into the vagina, the core and cover of the device provides tension free mid-urethral support for the temporary management of stress urinary incontinence (SUI). After a maximum of 8 hours of use in a 24 hours period, the device should be removed from the vagina using its pull string and discarded.

The IMPROVE BLADDER SUPPORT device by ConTIPI LTD is intended for the temporary management of stress urinary incontinence (SUI) in women as an over-the-counter device.

Here's an analysis of its acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

• Force required to push a device out of the applicator (insertion force)
• Retraction during device removal
• String detachment force
• Removal string integrity
• Force exerted on the vaginal wall |
  | Biocompatibility Testing | Non-cytotoxic, non-sensitizing, non-irritating, no systemic toxicity, no adverse local tissue reactions relevant to actual use. | All met:
• Cytotoxicity (ISO 10993-5:2009, 2nd edition): Non-cytotoxic
• Sensitization (ISO 10993-10:2010, 3rd edition): Non-sensitizing
• Vaginal Irritation (ISO 10993-10:2010, 3rd edition): Non-irritating
• Acute Systemic Toxicity (ISO 10993-11:2006, 2nd edition): No evidence of systemic toxicity
• Local Effects after Implantation (ISO 10993-6:2007, 2nd edition): No evidence of tissue reactions relevant to actual use |
  | Microbiological (S. aureus and TSST-1 contribution) | Not contribute to the development of S. aureus and TSST-1 when used as intended. | Evaluated. (Specific pass/fail criteria not explicitly stated, but implies positive outcome to support substantial equivalence). |
  | Shelf-life Study | Retain properties (microbiological load and performance) throughout its stated shelf life. | Met specifications and demonstrated substantial equivalence. |
  | Limited R&D Supporting Clinical Evaluation (Safety & Efficacy) | Demonstrate safety and efficacy substantially equivalent to the predicate device. | Substantially equivalent performance between the subject and predicate devices. Adverse events considered minimal, temporary, and resolved without medical treatment. |
  | Multicenter, Prospective, Randomized, Controlled, Cross-over Study (Vaginal Microflora) | No clinically significant change in vaginal microflora and no meaningful change compared to control (pad only). | Demonstrated no clinically significant change in vaginal microflora and no meaningful change compared to the control. No serious adverse events; few mild, anticipated device-related adverse effects (discomfort, spotting, bleeding, UTI). |
  | Selection and Labeling Comprehension Study (OTC Usability) | Users can appropriately determine product suitability (selection) and comprehend instructions for use (comprehension). | Selection study: Participants correctly identified appropriateness 92% of the time.
  Labeling comprehension study: Participants provided correct answers 96% of the time.
  (Lowest performance from low literacy group, but still acceptable and no additional risk). |

2. Sample Size and Data Provenance

• Limited R&D Supporting Clinical Evaluation: "limited patient population" - specific number not provided. Retrospective/Prospective and country of origin not specified, but likely prospective given it's part of a clinical evaluation for a new device.
• Multicenter, Prospective, Randomized, Controlled, Cross-over Study:
  • Sample Size: 45 subjects completed the study.
  • Data Provenance: "Multicenter, prospective, randomized, controlled, cross-over study" - this indicates a prospective study design. Country of origin not explicitly stated.
• Selection and Labeling Comprehension Study:
  • Sample Size: 45 women total (15 in each of three subgroups: low literacy, general population, elder population).
  • Data Provenance: Likely prospective and conducted for the purpose of this submission. Country of origin not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable, as expert-based ground truth is not explicitly mentioned for the clinical studies. The studies relied on direct clinical measures (e.g., vaginal microflora analysis, adverse event reporting) and participant responses to comprehension questions.
• Qualifications: If any expert analysis was involved in evaluating clinical outcomes, it is not detailed.

4. Adjudication Method (Test Set)

• Limited R&D Supporting Clinical Evaluation: Adjudication method not described.
• Multicenter, Prospective, Randomized, Controlled, Cross-over Study: Adjudication method for microflora analysis or adverse events not explicitly described, but "clinical evaluation" suggests medical oversight.
• Selection and Labeling Comprehension Study: A "moderator" questioned participants. No specific adjudication method across multiple experts is described for participant responses.

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

• No MRMC comparative effectiveness study was mentioned or performed. The clinical studies primarily focused on stand-alone device performance, safety, and a comparison to itself/control, or a comparison in a "limited R&D supporting clinical evaluation" to a predicate device. There was no study evaluating how human readers (or users in this context) improve with AI vs. without AI assistance, as this is a physical medical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Yes, in essence, the "Performance Data" and "Clinical Testing" sections primarily describe standalone performance of the device. While some comparisons are made to a predicate device or a control (pads), the core evaluation is on the device itself against predefined specifications and safety/efficacy endpoints. This is not an AI algorithm, so the term "algorithm only" is not directly applicable, but "device only" performance was evaluated.

7. Type of Ground Truth Used

• Design Verification Testing: Engineering specifications and benchmarks for physical/mechanical properties.
• Biocompatibility Testing: International ISO standards and their associated pass/fail criteria.
• Microbiological (S. aureus and TSST-1 contribution): Scientific understanding of microbial growth and toxin production.
• Shelf-life Study: Predefined performance metrics and microbiological load limits over time.
• Limited R&D Supporting Clinical Evaluation: Clinical assessment of safety and efficacy parameters by medical professionals, and potentially patient-reported outcomes.
• Multicenter, Prospective, Randomized, Controlled, Cross-over Study:
  • Vaginal Microflora: Objective microbiological analysis (likely culture-based or molecular methods) to quantify changes in flora.
  • Adverse Events: Clinical assessment by medical professionals and patient reporting.
• Selection and Labeling Comprehension Study:
  • Selection: Predefined correct answers to clinical scenarios based on product contraindications/indications.
  • Comprehension: Predefined correct answers to questions testing understanding of critical instructions.

8. Sample Size for the Training Set

• This is not applicable as the device is a physical pessary, not an AI/machine learning model that requires a training set. The "training" here would refer to the device's design and manufacturing process, which are based on engineering principles and material science.

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

• Not applicable for the reason stated above. The development of the device would involve iterative design, prototyping, and testing based on engineering principles, material science, and clinical feedback, rather than a "training set" in the AI sense.

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