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The DISPOSABLE BIOPSY FORCEPS FB-211D/221D/231D/241D are intended to be used to collect tissue within the tracheobronchial tree in combination with a bronchoscope

The Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, and FB-241D (also known as "EndoJaw") have been designed to collect tissue within the tracheobronchial tree in combination with a flexible bronchoscope. The Disposable Biopsy Forceps are inserted into the channel of a bronchoscope to collect tissue by biting the surface of the lesion with a pair of forceps located at the distal end of the device. The Disposable Biopsy Forceps are withdrawn from the channel and the tissue sample is collected.

The Disposable Biopsy Forceps consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a sheath, metallic coil (operating wire), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts. The subject device is available in multiple distal end cup shapes; FB-211D – Alligator jaw-step, FB-221D – Alligator jaw-step with needle, FB-231D – Oval type, and FB-241D – Oval type with needle.

This response is based solely on the provided FDA 510(k) Clearance Letter for the Olympus Disposable Biopsy Forceps.

Analysis of the Provided Document:

The provided document is an FDA 510(k) Clearance Letter for a medical device: Disposable Biopsy Forceps. This type of clearance is for devices that are "substantially equivalent" to legally marketed predicate devices. The key takeaway from this document is that the clearance is based on comparing the new device to a predicate device through non-clinical bench testing, not on clinical performance studies involving human subjects or AI-assisted diagnostic accuracy.

Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets related to diagnostic accuracy (which would be typical for an AI/software as a medical device) are not applicable to this specific 510(k) clearance documentation.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications tested during the non-clinical bench testing to demonstrate substantial equivalence to the predicate device.

Responses based on the provided FDA 510(k) Clearance Letter:

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

The document states: "All test samples passed pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each test and the detailed reported performance metrics are not explicitly provided in this summary. The document only lists the types of performance tests conducted.

2. Sample sizes used for the test set and the data provenance

• Sample Size: The document mentions "All test samples" but does not specify the numerical sample sizes used for each of the non-clinical bench tests.
• Data Provenance: The tests were conducted by Olympus. The document does not specify country of origin for data as this is a device clearance based on manufacturing and performance testing, not patient data from clinical studies. The testing was prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable as this 510(k) clearance is for a physical medical device (biopsy forceps) and is based on engineering performance demonstration through non-clinical bench testing, not on clinical diagnostic accuracy or interpretation of medical images/data (which would require expert ground truth).

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

This question is not applicable for the reasons stated in point 3. Adjudication methods are relevant for subjective image interpretation or clinical outcomes, not for objective bench test measurements of a physical device.

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 question is not applicable as the clearance is for a physical biopsy forceps and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable as the clearance is for a physical biopsy forceps and does not involve an algorithm.

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

This question is not applicable as the device is cleared based on non-clinical performance characteristics (e.g., insertion, withdrawal, force of jaws, sterility, shelf-life) which are evaluated against predefined engineering specifications and physical measurements, not against clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This question is not applicable as this is a physical medical device clearance, not an AI/machine learning device that requires a "training set."

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

This question is not applicable for the reasons stated in point 8.

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This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current.

The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube.

The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length.

The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.

Based on the provided text, the device in question is a "Disposable Hot Biopsy Forceps" and it is a Class II medical device. The document describes several non-clinical tests conducted to evaluate its performance and functionality against specific acceptance criteria.

However, it's crucial to note that the provided text explicitly states: "No clinical study is included in this submission." This means that the device's acceptance criteria and proven performance are based solely on non-clinical (bench) testing, not on human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance studies.

Therefore, for the following points, I can only provide information based on the non-clinical test data presented. Information related to clinical studies, human expert involvement, or AI performance will be marked as "Not Applicable" or "Not Provided" as per the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for each test item in a clear "acceptance criteria" column. Instead, the "Description" column implies the criteria (e.g., "smooth rotation and without interference" for rotation performance). The reported performance is generally stated as "has been verified" or "fulfilled." For "Conduction resistance," a numerical acceptance criterion and result are provided.

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many forceps were tested for pushability). It broadly states "Bench testing was performed."

• Sample Size: Not explicitly stated for individual tests. The phrasing "the subject device has been subjected to compliance testing" implies a sufficient number of units were tested to demonstrate compliance.
• Data Provenance: This is non-clinical bench test data, not patient data. The tests were performed in a lab setting by the manufacturer, Beijing ZKSK Technology Co., Ltd. (China). The document does not specify whether the data is retrospective or prospective, as this distinction typically applies to clinical studies.

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

• Number of Experts: Not applicable. These are non-clinical bench tests; ground truth is established by objective measurements against engineering specifications and industry standards, not by human expert interpretation of medical images or conditions.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As these are non-clinical, objective bench tests, there is no need for expert adjudication. The results are based on direct measurement or observation against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: No. The device is a physical medical instrument (forceps), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation is for the physical device itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, IEC), and predefined functional requirements. For example, the criterion for "Conduction resistance" ($\le 30 \Omega$) is an engineering specification. Biocompatibility is assessed against ISO 10993 standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI model requiring a training set. The design and validation of the device rely on established engineering principles and compliance with relevant medical device standards.

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The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope. The subject device is single-use biopsy forceps sterilized by Ethylene Oxide. The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample. The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.

This document describes the premarket notification (510(k)) for the Olympus Single Use Biopsy Forceps FB-456D. This device is a medical accessory and not an AI/ML powered device, therefore the typical AI/ML-related study criteria (data provenance, expert adjudication, MRMC studies, training/test set details, etc.) are not applicable here.

However, I can extract the relevant acceptance criteria and performance data for this device as detailed in the provided text.

Here's a breakdown of the acceptance criteria and the proof that the device meets them, based on the provided document:

Device: Single Use Biopsy Forceps FB-456D

Indications for Use: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines a series of non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests serve as the acceptance criteria for various performance aspects.

2. Sample Sizes and Data Provenance

• Sample Size for Test Set: This information is not explicitly provided in the document. For non-clinical, physical device testing, sample sizes are typically determined by engineering standards and statistical confidence levels, but the exact numbers are not detailed here.
• Data Provenance: The testing was conducted by Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd., both located in Japan. The testing is performed prospectively as part of the device development and validation process before market clearance.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring human expert interpretation for ground truth establishment. The "ground truth" here is based on objective, quantitative measurements and adherence to established engineering and biocompatibility standards.

4. Adjudication Method for Test Set

Not applicable. As this is not a diagnostic AI/ML device, there are no human expert readings requiring adjudication. Performance is assessed against pre-defined engineering specifications and standard compliance.

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

Not applicable. This is not an AI/ML-assisted diagnostic device, so no MRMC study looking at human reader performance with or without AI assistance was conducted.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical biopsy forceps, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements, adherence to internationally recognized scientific and engineering standards (e.g., ISO, ASTM), and in-house established acceptance criteria. For example, biocompatibility is assessed against ISO standards, sterility against ISO standards, and mechanical performance against defined engineering thresholds.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a "training set" of data.

9. How Ground Truth for Training Set Was Established

Not applicable. No training set for an AI/ML model.

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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."

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This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.

The main component of the proposed device is jaws, spring sheath and handle.

The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 to the power of -6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided FDA 510(k) summary (K180018) for the "Disposable Hot Biopsy Forceps" describes the acceptance criteria and the studies performed to demonstrate that the device meets those criteria.

Here's the breakdown of the information requested:

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

The document states that "Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion with a corresponding reported performance outcome. Instead, it lists the standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.

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

The document does not specify the sample sizes used for each of the non-clinical tests listed. It also does not explicitly state the provenance (country of origin, retrospective/prospective) of the data beyond the fact that Micro-Tech (Nanjing) Co., Ltd. is located in Nanjing, Jiangsu, China. The tests are described as "Non-Clinical Tests," implying laboratory or bench testing rather than human subject data.

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 applicable. The studies conducted are non-clinical (bench/laboratory tests) and do not involve human subject interpretation or expert ground truth establishment in the medical sense (e.g., radiologists interpreting images).

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

This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical study is included in this submission."

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

This is not applicable. The device is a physical medical instrument (Disposable Hot Biopsy Forceps), not a software algorithm, so the concept of standalone performance for an algorithm does not apply. The "performance" here refers to the physical and biological properties of the device meeting established standards.

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

For the non-clinical tests, the "ground truth" is established by the specifications and measurement techniques outlined in the referenced international and national standards (e.g., ASTM, ISO, USP). For example, a "sealed" package must pass specific dye penetration or burst strength tests as defined by the ASTM standards, and "sterility" is defined by the absence of microbial growth as per USP criteria.

8. The sample size for the training set

This is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require a "training set."

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

This is not applicable as there is no "training set" for this type of medical device submission.

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EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
Single Use Biopsy Forceps FB-433D: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope.

EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F: The BF-MP190F is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The BF-MP190F is indicated for use within the airways and tracheobronchial tree. The BF-MP190F is a flexible video endoscope used for endoscopic diagnosis and treatment within the respiratory organs and a modification of the BF-Q190 which was previously cleared under K121959. The BF-MP190F has been designed to be applicable for diagnosis and treatment in the peripheral portion of the tracheobronchial trees compared to the predicate model. The basic principle, the user interface and operation for the bronchoscopic procedure of the BF-MP190F is identical to the predicate BF-Q190.
Single Use Biopsy Forceps FB-433D: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. Identical to the predicate device, the subject device is inserted into the channel of an endoscope to collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Then users withdraw the subject device from the channel and collect samples.

The provided text describes a 510(k) premarket notification for an Olympus bronchoscope (BF-MP190F) and single-use biopsy forceps (FB-433D). The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than presenting a study where a device's performance is measured against predefined acceptance criteria. Therefore, the requested information, which pertains to such a performance study and acceptance criteria specific to an AI/algorithm-based device, is largely not available in this document.

Here's an analysis of what information is available or implied, and what is not:

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

• Not Available. The document does not describe specific numerical acceptance criteria or performance metrics for the device (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests conducted to demonstrate safety and effectiveness. The acceptance criteria for these tests are generally implied to be "meeting established in-house criteria" or compliance with specific ISO/ASTM standards (e.g., ISO 14971 for risk analysis, ISO 10993 for biocompatibility, etc.). These are related to manufacturing and safety, not diagnostic or clinical accuracy.

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

• Not Available. The document outlines a series of non-clinical tests (e.g., thermal safety, mechanical durability, forceps operation, dimension, package integrity, software validation, EMC, electrical safety, reprocessing validation, sterilization validation, shelf-life testing). These typically involve a small number of physical samples of the devices themselves, performed in a lab setting, rather than a "test set" of clinical data with human subjects or patient samples. The concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical performance study.

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

• Not Applicable/Not Available. Since this is a non-clinical evaluation of hardware and accessories, there is no "ground truth" establishment in the sense of expert clinical diagnosis or interpretation. The tests assess the physical and functional characteristics of the device against engineering specifications and safety standards.

4. Adjudication method for the test set

• Not Applicable/Not Available. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical ground truth, which is not part of this device's evaluation as 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 Applicable. This document describes a bronchoscope and biopsy forceps, which are physical medical instruments. It does not describe an AI or algorithm-driven device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

• Not Applicable. As mentioned above, this document does not concern an algorithm-driven device.

7. The type of ground truth used

• Not Applicable/Not Available. For the non-clinical tests performed, "ground truth" would be established by objective measurements and compliance with engineering specifications, safety standards, and performance test protocols (e.g., a "thermal safety test" would have an objective temperature limit). It does not involve expert consensus, pathology, or outcomes data in the context of clinical performance.

8. The sample size for the training set

• Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.

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

• Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.

Summary based on the provided text:

The submission focuses on demonstrating substantial equivalence of a new bronchoscope and biopsy forceps to previously cleared predicate devices, primarily through engineering and safety evaluations. The modifications include changes in the bronchoscope's CCD unit position, outer diameter, instrument channel size, optical properties, and materials, as well as additional sterilization methods. For the biopsy forceps, changes relate to compatible devices, maximum diameter and length, and cup size/material.

The "study" in this context refers to a series of non-clinical tests designed to verify that these modifications do not raise new safety or effectiveness concerns and that the devices comply with relevant international standards.

This submission is a traditional 510(k) for a physical medical device, not an AI/ML-driven device, so many of the requested categories related to algorithm performance, training data, and expert review of clinical cases are not applicable.

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The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.

The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.

The provided document is a 510(k) premarket notification for the Captura® Disposable Hot Biopsy Forceps. This type of submission focuses on demonstrating substantial equivalence to an existing legally marketed device, not necessarily extensive clinical trials proving novel performance or the use of AI.

Therefore, the specific information requested, such as acceptance criteria, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This document is for a medical device (biopsy forceps), not an AI/software as a medical device (SaMD).

Here's what can be inferred from the document regarding performance and validation:

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

The document broadly states that the device meets performance criteria required for its intended use, but does not provide specific acceptance criteria values or detailed performance metrics in numerical form.

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

This information is not provided. The testing mentioned is primarily non-clinical bench testing.

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 applicable and not provided. The device is a physical tool, and its performance is assessed through engineering and bench tests, not expert interpretation of diagnostic data.

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

This information is not provided and not applicable for the type of testing 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 applicable. This device is not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm or SaMD. The performance assessment is for a physical medical device.

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

For physical and electrical performance tests, the "ground truth" would be established by validated test methods, adherence to relevant standards, and engineering specifications. For example, a tensile test would measure a force against a specific standard for material strength. Biocompatibility would be assessed against ISO standards.

8. The sample size for the training set:

Not applicable. There is no AI model or training set described in this document.

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

Not applicable. There is no AI model or training set described in this document.

In summary: The provided document describes the regulatory submission for a physical medical device (biopsy forceps). The assessment of this device's safety and effectiveness relies on non-clinical bench testing, electrical safety, biocompatibility, sterilization, and shelf-life data, demonstrating substantial equivalence to a predicate device. It does not involve AI, clinical efficacy studies with human subjects for diagnostic accuracy, or associated ground truth establishment methods typically found in AI/SaMD submissions.

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This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

The Captura® Disposable Bronchoscope Biopsy Forceps (subject device) represents modifications made to the Disposable Bronchoscope Biopsy Forceps (predicate device) currently cleared to market via 510K K923847 by Wilson-Cook Medical, Inc. The Captura® Disposable Bronchoscope Biopsy Forceps consist of a spool handle, coated coilspring catheter, drive cable, forceps cups and forceps housing.

The bronchoscope biopsy forceps is used by passing the device through a prepositioned endoscope to the targeted location. The forceps cups are attached on one end of the coilspring sheath with the spool handle attached to the opposite end. The handle is actuated by moving the spool forward to open the forceps cups and backward to close. The Captura® Bronchoscope Biopsy Forceps have a surgical rim edge around the circumference of the cups and the cups are fenestrated. The cups are opened and pressed against the biopsy site. When the cups are closed, they are pulled away from the biopsy site, pinching off the top surface, obtaining a tissue biopsy.

This document is a 510(k) premarket notification for the Captura® Bronchoscope Biopsy Forceps, a medical device. It does not describe a study involving machine learning, AI, or software, but rather a traditional medical device equivalency assessment. Therefore, most of the questions about acceptance criteria, AI performance, ground truth, and training sets are not applicable.

Here's the information that can be extracted from the provided text, aligning with the spirit of your request where possible:

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

Since this is a submission for a physical medical device, there isn't a direct "performance metric" like accuracy or precision as would be found in an AI/ML study. Instead, the "performance" relates to demonstrating the device functions comparably to a predicate device and adheres to safety and functional standards.

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

The document does not specify general "sample sizes" in terms of patient data or clinical images, as this is not an AI/ML study. Instead, testing involves physical exemplars of the device. The text states:

• Sample Size: Not specified for individual tests. Testing would typically involve multiple units of the device for each test (e.g., several devices for flex and fracture, multiple packaged units for burst/dye leak tests).
• Data Provenance: The testing was conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. This is a medical device manufacturer based in Winston-Salem, North Carolina, USA. The data is from in-house design verification and validation testing, which is prospective for the purpose of demonstrating substantial equivalence.

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 applicable. This is a submission for a physical medical device. "Ground truth" in this context refers to engineering specifications, validated test methods, and compliance with standards, not expert medical opinion on diagnostic images or data.

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

Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 are typically used for interpreting ambiguous cases or establishing ground truth in clinical or imaging studies involving human readers, which is not relevant here.

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. This is a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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 physical biopsy forceps device.

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

The "ground truth" for this medical device's performance is established by:

• Engineering Specifications: The design and manufacturing specifications of the device.
• Validated Test Methods: Adherence to established scientific and engineering principles for testing functionality, durability, and safety.
• Regulatory Standards: Compliance with FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility).
• Predicate Device Performance: The cleared performance of the previously marketed predicate device (Disposable Bronchoscope Biopsy Forceps, K923847) serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for this physical medical device.

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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 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.

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FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.

The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:

• an actuating handle ergonomically designed for comfortable use, 1.
• 2. a flexible shaft,
• and surgical stainless steel cutting jaws. 3.
  At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.
  The product is provided single for use and sterile.

The provided document is a 510(k) premarket notification for a medical device called "Biopsy Forceps." It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. The document includes non-clinical performance data to support its claims but does not include details about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML devices (e.g., performance metrics like accuracy, sensitivity, specificity).

Instead, the document focuses on demonstrating physical and biological compatibility and functionality for a mechanical medical device. Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:

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

The document states that "All samples passed the test and met the acceptance criteria" for several non-clinical tests, but it does not explicitly define those acceptance criteria. The reported "performance" is simply that the device met these (unspecified) criteria.

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

The document mentions "All samples" for the dimensional, tensile, and shelf life tests, but it does not specify the exact number of samples.

For the Simulation Test - Insertion and Taking of Tissue Samples:

• Sample Size: "The process was repeated 10 times per device." The number of devices used is not specified.
• Data Provenance: No country of origin or retrospective/prospective nature is specified for the non-clinical tests. The tissue samples were "fresh porcine heart specimens."

For Biocompatibility: "The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells." No specific sample size (number of cells or test articles) is given, beyond indicating "the test article."

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 applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study requiring expert consensus for ground truth.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device.

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. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm. The performance tests ("Dimensional Verification," "Tensile Tests," "Simulation Test - Insertion and Taking of Tissue Samples," "Shelf Life Testing") are effectively "standalone" tests of the device itself.

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

For the non-clinical performance tests:

• Dimensional Verification: Comparison to engineering specifications/manufacturing tolerances (implied).
• Tensile Tests: Comparison to mechanical strength specifications (implied).
• Simulation Test: Successful introduction and harvesting of tissue samples from "fresh porcine heart specimens" (functional verification).
• Shelf Life Testing: Maintenance of specified performance after accelerated aging/transport simulation.
• Biocompatibility: Results from standardized cytotoxicity, chemical characterization, and previous toxicological data compared against ISO 10993-1 requirements.

8. The sample size for the training set

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm.

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