Search Results

Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.

The SOPRO 184 is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and color contrast. Its contour enhancer gives the impression of a 3D image. This makes the camera a multidisciplinary tool. The SOPRO 184 is a modification of the SOPRO 162 previously cleared on 510(k) K031593. The modifications are the addition of RGBS & USB2 outputs, 2 SD1 outputs as an option and the modification of the head design for the ergonomic.

The provided text (K082796) is a 510(k) summary for a medical device called the SOPRO 184 Digital Endoscopy Camera. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing data from a clinical study with specific acceptance criteria and performance metrics described in your request.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For devices claiming substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is typically done through comparing technical specifications, materials, and intended use, rather than presenting a performance table against predefined numerical criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and therefore not provided in this 510(k) summary. The document does not describe a "test set" in the context of a performance study to validate specific acceptance criteria for the SOPRO 184. The evaluation is based on comparing the new device's specifications to its predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided. No "ground truth" was established for a test set in the context of a performance study for the SOPRO 184 as described in this document.

4. Adjudication Method

This information is not applicable and therefore not provided. No adjudication method was used for a test set in the context of a performance study for the SOPRO 184 as described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not mentioned and likely not conducted for the SOPRO 184's 510(k) submission. This type of study is more common for AI-powered diagnostic devices where human reader performance is a critical outcome. The SOPRO 184 is a camera system for visualization.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not mentioned and likely not conducted. The SOPRO 184 is a digital endoscopy camera, not an algorithm in the sense of AI-driven analysis. Its performance is evaluated based on image quality, output options, and ergonomic design, usually through engineering tests and comparison to the predicate, not a standalone algorithmic performance study.

7. Type of Ground Truth Used

This information is not applicable and therefore not provided. As no performance study with a test set and ground truth establishment is described, this question cannot be answered from the provided text.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The SOPRO 184 is a camera system, not an AI model that requires a "training set" in the traditional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As the device is not an AI model requiring a training set with a ground truth, this question cannot be answered from the provided text.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in a 510(k) context):

The "study" in this 510(k) context is primarily a comparison of technical specifications and intended use between the SOPRO 184 and its predicate device, the SOPRO 162 (K070102).

• Acceptance Criteria for a 510(k): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate.
• Proof of Meeting Acceptance Criteria: The document explicitly states: "The SOPRO 184 is substantially equivalent to the predicate device by SOPRO, the SOPRO 162 (K070102) previously cleared by the FDA and currently marketed." It further elaborates: "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 184."

The specific modifications of the SOPRO 184 over the SOPRO 162 (K031593, which K070102 was also based on) include:

• Addition of RGBS & USB2 outputs.
• Addition of 2 SD1 outputs as an option.
• Modification of the head design for ergonomic purposes.

The FDA's clearance letter (pages 2-4) confirms that based on the provided information, the FDA "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "study" is a technical comparison and declaration of equivalence reviewed by the FDA, rather than a clinical trial with specific performance metrics against an established ground truth. This is a common approach for devices undergoing the 510(k) pathway, especially when the changes from a predicate are minor.

Ask a specific question about this device