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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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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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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 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 loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current to cut polyp with the loop.

The main component of the proposed device is jaws, spring sheath and handle. The proposed 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 has two (2) specifications, HBF55-11023180 and HBF55-11023230. The proposed devices are 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 provided document is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Disposable Hot Biopsy Forceps. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria in the context of a new, innovative medical device relying on clinical performance metrics.

Instead, the document details physical and performance characteristics to argue that the proposed device is similar enough to an already approved device. Therefore, a direct answer to the request regarding acceptance criteria and a study that proves the device meets the acceptance criteria as would be typical for a clinical trial or performance study of a diagnostic or treatment effectiveness device, cannot be fully provided from this document.

Here's an analysis based on the information available:

The core "acceptance criteria" here are that the proposed device performs as well as the predicate and is substantially equivalent. The "study" is a series of bench tests comparing the proposed device against established performance benchmarks or implicitly, the performance of the predicate device (though explicit comparative data is not provided in detail).

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the bench tests (e.g., how many forceps were tested for cutting performance). The data provenance is implied to be from in-vitro bench testing conducted by Micro-Tech (Nanjing) Co., Ltd. There is no mention of country of origin of data in a patient context, as no clinical data was used. All testing appears to be prospective testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is not applicable to the provided document. The "ground truth" for these bench tests would be engineering specifications and validated test methods, not expert clinical consensus or interpretation for a diagnostic device.

4. Adjudication method for the test set:
This is not applicable as the testing performed was bench testing against engineering specifications, not clinical outcomes requiring 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:
This is not applicable. The device is a physical surgical instrument (hot biopsy forceps), not an AI-powered diagnostic or treatment assistance tool. No MRMC study was performed or is relevant.

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 instrument, not an algorithm.

7. The type of ground truth used:
For the bench testing, the "ground truth" would be engineering specifications, material properties, and performance standards relevant to medical devices of this type, likely derived from recognized consensus standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.

8. The sample size for the training set:
This is not applicable. There is no machine learning or AI algorithm being developed; therefore, there is no "training set."

9. How the ground truth for the training set was established:
This is not applicable as there is no training set.

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