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CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non- neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

The provided document describes the CompactCath Intermittent Urinary Catheter and its substantial equivalence to a predicate device, K100878 Self Cath Catheter Coloplast A/S. The information about the acceptance criteria and the study that proves the device meets them is limited, as the document focuses on demonstrating substantial equivalence rather than presenting a detailed clinical study report with, for example, a standalone algorithm performance, or an MRMC study.

However, based on the Testing section and the Performance specifications & testing summary (avg.) table, we can extract the following information:

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

Note on Acceptance Criteria: The document states "Product testing was completed and met the acceptance criteria." The table above extrapolates the "acceptance criteria" from the reported performance of the predicate device (Coloplast) as the basis for comparison to demonstrate substantial equivalence. The CompactCath performance is then compared directly against these values. For some criteria, the CompactCath matches or is within an acceptable range, while for others (like shelf life), the difference is acknowledged and deemed equivalent in the context of substantial equivalence, not necessarily identical.

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 for Test Set: The document does not explicitly state the sample sizes used for the various tests (flow measurements, bond strength, deployment, insertion force, biocompatibility, sterilization validation, expiry dating). It only mentions that testing was completed.
• Data Provenance: Not specified. The studies appear to be in-house laboratory testing of the devices, not human clinical trials or data from specific countries of origin. They are therefore prospective in nature, as they involve testing the manufactured devices.

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. The tests performed are engineering and laboratory tests (e.g., flow rate, force measurement, biocompatibility, sterilization validation), not subjective assessments requiring expert consensus on a "ground truth" in the way a medical image or diagnostic test would.

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

Not applicable, for the same reasons as point 3.

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

No. This type of study (MRMC for AI assistance) is not relevant to this medical device, which is a physical intermittent urinary catheter, not an AI-powered diagnostic or therapeutic system.

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

Not applicable, as it's a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests appears to be the measured performance data of the legally marketed predicate device (Coloplast Self Cath Catheter). For other tests like biocompatibility, the ground truth is adherence to recognized standards (ISO10993). For sterilization, the ground truth is validated sterilization cycles achieving a specific SAL (10^-6).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as explained in point 8.

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