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This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The product is only intended for adult populations.

Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.

During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups. the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.

By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.

This document is a 510(k) summary for the Olympus Single Use Hot Biopsy Forceps FD-231. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

**The document does not describe: **

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes. This document focuses on the design and safety aspects of a medical device (hot biopsy forceps), not a diagnostic algorithm. Therefore, typical metrics like sensitivity, specificity, or AUC, as would be relevant for an AI/ML-based diagnostic device, are not applicable here.
• Sample size used for a "test set" in the context of diagnostic performance. The "tests" here are engineering and safety validations.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, this document describes:

The document describes non-clinical testing to demonstrate the safety and effectiveness of the device, focusing on substantial equivalence to a predicate device. The acceptance criteria in this context are established by engineering standards and internal risk analysis, rather than diagnostic performance metrics.

Here's what can be extracted regarding acceptance criteria and performance, as appropriate for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Validation)

While not presented in a formal table with pass/fail remarks for each test, the document lists the types of non-clinical tests performed and implies that the device met the criteria for each, as it received 510(k) clearance.

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

• Sample Size: Not explicitly stated as a number of devices/units for each test. However, the performance of these tests (e.g., biocompatibility) typically involves a sufficient number of samples as dictated by the relevant standards.
• Data Provenance: The device is manufactured by Aomori Olympus Co., Ltd. in Japan. The tests are non-clinical (laboratory/bench testing) and performed according to international standards (ISO, ASTM, IEC, AAMI/ANSI). The data's "provenance" here refers to the engineering validation processes, likely conducted at the manufacturer's or qualified testing facilities. Retrospective/prospective is not applicable as this is not clinical performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This is not a study assessing diagnostic "ground truth" established by human experts. The "ground truth" for the non-clinical tests are the objective measurements and adherence to specified engineering and safety parameters outlined in the standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication of diagnostic images is involved. The "test set" here refers to the physical devices undergoing engineering and safety validation, with acceptance being based on meeting quantitative criteria from standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is for evaluating the impact of a diagnostic AI on human reader performance. This device is a surgical instrument, not a diagnostic AI.

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

• Not Applicable. There is no algorithm or AI component to this device. Its performance is purely mechanical and electrical, measured through non-clinical bench testing.

7. The Type of Ground Truth Used:

• Engineering Specifications and Standard Requirements: The "ground truth" for this device's performance acceptance is its adherence to a robust set of international and industry standards (e.g., ISO, IEC, AAMI/ANSI, ASTM) covering electrical safety, biocompatibility, sterilization, packaging, and functional mechanical properties. These standards define the acceptable range or threshold for specific measurements.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set.

In summary, this document demonstrates regulatory clearance for a medical device (hot biopsy forceps) based on non-clinical engineering and safety testing, showing substantial equivalence to a predicate device. It explicitly states that:

• Validation from non-clinical testing demonstrated that the differences (compatible endoscope/accessories, electrical specification, material composition/configuration of handle/insertion) do not raise further problems on safety or effectiveness.
• "The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment" (based on ISO 14971).
• The conclusion is that the device "does not demonstrate any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device."

Ask a specific question about this device

This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.

The Single Use Hot Biopsy Forceps FD-231 consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.

During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.

By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.

The provided document describes a medical device, the "Single Use Hot Biopsy Forceps FD-231," and its premarket notification for FDA clearance (K171916). However, the document does not contain information about acceptance criteria and a study proving that the device meets those criteria, specifically in the context of AI/algorithm performance or a multi-reader multi-case study as requested in the prompt.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of performance specifications, material biocompatibility, electrical safety, and sterilization. It lists various tests performed to ensure the safety and effectiveness of the device as a physical medical instrument, not an AI or software-based diagnostic tool.

Therefore, I cannot provide the requested information for acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because these are not present in the provided text.

The closest information relating to "acceptance criteria" not directly tied to AI/algorithm performance is mentioned in the "Summary of non-clinical testing" section:

• Risk Analysis: "Finally, risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971 Second edition 2007-03-01. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
• Sterilization Residuals: "The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012."

These references describe general acceptance criteria for risks and sterilization, which are standard for medical devices but do not relate to the performance metrics of an AI system or clinical study outcomes.

Ask a specific question about this device