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

S-357 Video Imaging System

This 510(k) submission (K973798) for the SOPRO S-357 Video Imaging System does not contain a study that establishes acceptance criteria or device performance in the way typically expected for AI/ML devices or novel medical technologies.

Instead, the submission relies on the concept of substantial equivalence to predicate devices already on the market. This means the manufacturer argues their device is safe and effective because it is very similar to other legally marketed devices, rather than providing independent performance data against specific acceptance criteria.

Therefore, many of the requested elements for a study showing acceptance criteria and performance cannot be directly extracted from this document in the traditional sense.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The submission explicitly states: "SOPRO feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution." and "Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device." This indicates that no specific performance metrics or acceptance criteria were established or measured for this device against a predefined standard.

2. Sample sized used for the test set and the data provenance:

Not applicable. There is no test set or study conducted to evaluate the S-357's performance against specific metrics. The substantial equivalence argument relies on the established safety and effectiveness of the existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established by experts for a test set, as no performance study was conducted.

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

Not applicable. No test set or adjudication method was used.

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, an MRMC study was not done. This device is a video imaging system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a video imaging system, not an algorithm, and its function inherently involves human operation and interpretation.

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

Not applicable. No ground truth was used for a performance study. The "ground truth" in this context is the presumed safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm and does not have a training set or associated ground truth.

In summary, this 510(k) submission is for a medical device (a video imaging system) that was cleared based on its substantial equivalence to existing devices, not on a performance study with defined acceptance criteria, ground truth, or expert evaluation. The information provided focuses on demonstrating the similarity in design, technology, specifications, and intended use to predicate devices from companies like Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus.

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

S - 35 9 Video Imaging

The provided text is a 510(k) summary for the SOPRO S-357 Video Imaging System. This document asserts substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.

Therefore, the document does not contain information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, or adjudication methods.

Here's an explanation of why the requested information cannot be extracted from the given text:

• Substantial Equivalence (510(k)) vs. Performance Studies: The 510(k) pathway for medical device approval in the US focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance claims to the predicate. It does not generally require de novo clinical trials or rigorous performance studies with predefined acceptance criteria in the same way a PMA (Pre-Market Approval) or some other regulatory pathways might.
• Content of the 510(k) Summary: The summary states: "SOPRO feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already In commercial distribution are : Circon/ACMI, Storz, Stryker, Smith & Nephew and Olympus, just to name a few. The design of the S-357 is virtually identical to the comparative devices... Since the design is comparable, tcchnology virtually identical, the specifications very similar, and the intended use the sames. SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device." This clearly indicates a comparative approach based on similarity, not an independent performance study with measurable outcomes.

Thus, I cannot fill in the requested table or answer the questions related to performance studies, ground truth, or expert involvement because the provided text does not contain that information.

The document does provide:

• Device Name: S - 359 Video Imaging (though the summary refers to S-357, and the FDA letter refers to "Video Endoscopic Camera" and uses K972540, implying the S-357/S-359 are closely related or the same product with a minor naming discrepancy in the document).
• Intended Use/Indications For Use: "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals."

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The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.

The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.

This document does not contain the requested information regarding acceptance criteria or a study proving device performance. The provided text is a 510(k) summary (revision 1) for the Del Medical Systems S-357 Video Imaging System, dated October 15, 1996.

The summary primarily focuses on demonstrating substantial equivalence to already marketed devices. It argues that the S-357 is "virtually identical" in design and technology to comparative devices like those from Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus. The argument for substantial equivalence is based on:

• Identical design: "The design of the S-357 is virtually identical to the comparative device..."
• Comparable technology: "...technology virtually identical..."
• Similar specifications: "...the specifications very similar..."
• Same intended use: "...and the intended use the same as those above listed devices..."

The document asserts that "these minor differences have no impact on the safe use and/or effectiveness of the device." It also mentions incorporating other legally marketed devices to "illustrate the wide, general use of similar other devices," implying that widespread historical use of similar devices suggests the S-357's safety.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, not a performance study report.

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