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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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The design of the nD Vision-220, Medical Adaptive Image Processor for Medical Applications is virtually identical to the comparative device manufactured and sold by Digivision.

The provided document is a 510(k) summary for the nD VISION-220, a Medical Adaptive Image Processor. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (DigiVision's device) rather than detailing specific performance criteria or a study designed to prove those criteria.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not available in the provided text.

Here's a breakdown of what can be gathered and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the document. The general acceptance criterion seems to be "substantially equivalent" to the predicate device in terms of design, technology, specifications, and intended use, with minor differences having no impact on safety or effectiveness.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) are reported for the nD VISION-220. The document states that the "specifications [are] similar" to the predicate device, implying similar performance, but no actual data is provided.

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

• This information is not available in the provided summary. No test set or specific data is mentioned.

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)

• This information is not available in the provided summary. There is no mention of experts or ground truth establishment for a test set.

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

• This information is not available in the provided summary. 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

• This information is not available in the provided summary. The document does not describe any MRMC study or the use of AI assistance for human readers. This device is described as an "Adaptive Image Processor," which would likely enhance images before human interpretation, rather than an AI assisting human interpretation directly in a comparative effectiveness study.

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

• This information is not available in the provided summary. No standalone performance study details are provided.

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

• This information is not available in the provided summary.

8. The sample size for the training set

• This information is not available in the provided summary. No training data or training set size is mentioned.

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

• This information is not available in the provided summary.

In summary, the provided 510(k) summary focuses solely on demonstrating substantial equivalence based on design, technology, specifications, and intended use, rather than detailing a performance study with specific acceptance criteria, test sets, or ground truth establishment. This type of summary often relies on the predicate device's existing clearance and performance, assuming similar performance for the new device due to its comparable nature.

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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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The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3.

This document, "Exhibit 9: 510(k) Summary," is a regulatory filing for a medical device called the "S-53 Video Imaging System." It aims to demonstrate substantial equivalence to previously cleared devices.

Crucially, this document is a summary statement for a 510(k) premarket notification. It does not provide a study to prove the device meets acceptance criteria in the way a clinical trial report or a performance validation study would. Instead, it asserts substantial equivalence based on design, technology, specifications, and intended use being "virtually identical" or "very similar" to predicate devices.

Therefore, I cannot fulfill most of your request directly from the provided text, as the information you're asking for (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is typically found in detailed performance studies, not in a 510(k) summary claiming substantial equivalence.

Here's what can be inferred or stated based on the provided text, and where the requested information is not available:

1. Table of acceptance criteria and reported device performance:

   • Not available in the provided text. This document does not present specific performance metrics or acceptance criteria for the S-53 Video Imaging System. It relies on the premise that its performance is implicitly acceptable because it's "virtually identical" to pre-existing, legally marketed devices.

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

   • Not available in the provided text. No test set or associated data provenance is mentioned.

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

   • Not applicable/Not available. No new ground truth establishment is described in this summary.

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

   • Not applicable/Not available. No test set or adjudication process is mentioned.

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 applicable/Not available. This device is a "Video Imaging System" and there is no indication of AI assistance or MRMC studies for reader improvement.

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

   • Not applicable/Not available. This device is an imaging system, not an algorithm, and no standalone performance study is mentioned.

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

   • Not applicable/Not available. No ground truth for new performance validation is discussed.

8. The sample size for the training set:

   • Not applicable/Not available. This summary does not describe an AI/algorithm that would require a training set.

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

   • Not applicable/Not available. As above, no training set is discussed.

Summary based on the provided text:

The provided document is a 510(k) Summary for the "S-53 Video Imaging System." Its purpose is to argue for substantial equivalence to predicate devices such as the Fuji Optical Systems-Dentacam, New Image-Accucam, and other listed devices (IDT, Welch Allyn, Dentsply, Air Technologies).

The core argument for substantial equivalence is based on:

• Design: "virtually identical to the comparative devices"
• Technology: "virtually identical"
• Specifications: "very similar"
• Intended Use: "the same"

The document asserts that "minor differences have no impact on the safe use and/or effectiveness of the device," thereby implying the S-53 meets the same level of safety and effectiveness as the predicate devices without needing a separate, detailed performance study with new acceptance criteria or ground truth establishment. The wide commercial distribution and "safe use" of similar devices are also cited as supporting evidence.

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the intended use the same

The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3.

The provided text is a 510(k) summary for the Del Medical Systems S-41 and S-41S Video Imaging System. This document is focused on demonstrating substantial equivalence to existing predicate devices (primarily the MSV-2000 and other legally marketed video imaging systems for medical use) rather than presenting a study with acceptance criteria and device performance results.

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment can be extracted from the provided text.

The document explicitly states its purpose is to show substantial equivalence based on:

• Virtually identical design to comparative devices.
• Virtually identical technology.
• Very similar specifications.
• Same intended use.
• Belief that minor differences have no impact on safe use and/or effectiveness.

This type of submission typically relies on existing knowledge and safety records of the predicate devices rather than new performance studies with specific acceptance criteria as you've described.

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