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510(k) Data Aggregation
(35 days)
Operative and Diagnostic Cystoscopy for visual imaging and light transmission.
Cystoscopes
The provided 510(k) submission for the Medifix Inc. Cystoscopes is very brief and lacks detailed information regarding specific performance testing and acceptance criteria. It primarily focuses on demonstrating substantial equivalence to older predicate devices through design comparisons.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety and Effectiveness | "as safe and effective as all other devices earlier and currently on the market" | This is a general claim of equivalence, not a specific, quantifiable criterion. No performance metrics are provided. |
| Mechanical Stress Testing | "extense mechanical...stress testing to assure safe and long term use." | No specific thresholds (e.g., force, cycles) or measured outcomes are provided. |
| Thermic Stress Testing | "extense...thermic stress testing to assure safe and long term use." | No specific temperature ranges, durations, or measured outcomes are provided. |
| No Adverse Health Effects | "We are not able to determine any adverse health effects compared to the already marketed devices and can not imagine any possibility of this kind." | This is a declarative statement, not a result of a specific test with predefined acceptance. |
| Material/Component Equivalence | "designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry." | This implies an acceptance criterion of using established components, but no performance data for these components in the prototype is reported. |
| Substantial Equivalence to Predicate | "found substantial equivalence in all significant details" compared to R. Wolf devices. | This is a conclusion of the comparison, not a performance metric of the device itself. Specific details of the comparison that constituted "significant details" are not provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "Cystoscope prototypes" but does not indicate how many prototypes were tested or how many individual test units were subjected to "extensive mechanical and thermic stress testing."
- Data Provenance: Not specified. The data would be prospective, as it involves testing their own prototypes. However, the location or specific conditions of the testing are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only states "We compared our Cystoscope prototypes in detail to much older equipment..." implying internal assessment, but no details on who performed this assessment or their qualifications.
4. Adjudication method for the test set
- Adjudication Method: Not specified. It appears that the assessment was internal ("We compared..."), implying no formal external adjudication process.
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
- MRMC Study: No. This device is a passive optical instrument (cystoscope), not an AI-powered diagnostic tool. Such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the performance testing appears to be comparison to established, predicate devices. The submission states they compared their prototypes to "much older equipment, manufactured by R.Wolf and other Manufacturers" and concluded they are "as safe and effective." For the design comparison, the "ground truth" was the "manufacturing drawings with corresponding devices from R.Wolf." There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for 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
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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