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Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals

S-52 Video Laparoscope

Based on the provided text, the submission is a 510(k) premarket notification for the SOPRO S-52 Video Laparoscope. This type of submission asserts substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided document.

Here's an analysis of the information that can be extracted and a clear indication of what is not available:

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

• Not provided. The document indicates the S-52 Video Laparoscope is considered substantially equivalent to existing devices (Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus) because its "design is virtually identical," "technology virtually identical," "specifications very similar," and "intended use the same." This implies that the device is expected to perform comparably to these predicate devices, but no specific performance metrics or acceptance criteria are stated, nor are any direct performance results reported for the S-52.

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

• Not provided. No test set or associated data is mentioned, as this is a substantial equivalence submission based on design and technological similarity, not a performance study.

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 provided. No test set or ground truth establishment process is described.

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

• Not provided. No test set or adjudication method is described.

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 provided. This device is a video laparoscope, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Not provided. This is a hardware device (video laparoscope), not an algorithm or AI system. Standalone algorithm performance is not relevant or described.

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

• Not provided. No ground truth is mentioned, as no performance study was conducted or reported.

8. The sample size for the training set

• Not provided. No training set is applicable or mentioned for this type of device and submission.

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

• Not provided. No training set or ground truth establishment process is applicable or described.

Summary of what is known:

• Device Name: SOPRO S-52 Video Laparoscope
• Regulatory Status: Substantially Equivalent (K973795) to existing devices.
• Predicate Devices: Circon/ACMI, Storz, Stryker, Smith & Nephew, Olympus.
• Basis for Equivalence: Virtually identical design, technology, very similar specifications, and same intended use as predicate devices.
• Intended Use: "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals."

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The S-52 Electronic Video Laparossope

This document does not contain the information required to populate the fields of the request. The text describes a submission for substantial equivalence for a medical device (S-52 Electronic Video Laparoscope) by Del Medical Systems, comparing it to existing predicate devices (e.g., Fujinon's EVL-R, Smith & Nephew devices).

The document focuses on:

• Claim of Substantial Equivalence: Stating that the S-52 is substantially equivalent in technology and intended use to predicate devices.
• Comparison of Design and Technology: Highlighting similarities in design, technology, specifications (with a noted difference in flexibility not affecting use), and intended use.
• Predicate Devices: Listing specific predicate devices and their K-numbers (e.g., Fujinon under K-902197/B and K912859/A, and generally "Smith & Nephew and Welch Allyn as makers/marketers of 'distal end CCD devices'").

However, it does not provide any information on:

• Acceptance criteria: No specific performance metrics or thresholds are mentioned.
• Reported device performance: No data on the S-52's performance against any criteria are presented.
• Study details: No mention of any clinical or technical study, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or effects of AI assistance.
• Standalone algorithm performance: This is not an AI/algorithm-based device in the context of the document.
• Training set information: Not applicable as no machine learning algorithm is discussed.

Therefore, the requested tables and details cannot be extracted from this provided input. This document is a regulatory submission arguing for substantial equivalence based on design and intended use, not a performance study report.

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