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The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.

The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.

The provided document is a 510(k) summary for the Olympus Disposable Grasping Forceps FG-52D/FG-54D. It outlines the device's characteristics, indications for use, comparison to a predicate device, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. Instead, it lists the types of tests conducted to demonstrate safety and effectiveness. The "acceptance criteria" are implied by the successful completion and positive results of these tests, leading to the conclusion of substantial equivalence.

Here's a re-formatted table based on the provided "Performance Data" section:

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

The document does not specify exact sample sizes for each test conducted. It generally states that "Performance Data" was provided. For the provenance, the data seems to be from non-clinical bench testing conducted by the manufacturer, Olympus Medical Systems Corp. The document does not mention the country of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing.

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

This information is not applicable to this submission. The device is a physical medical instrument (graspers), not an AI/ML algorithm that requires expert labeling for ground truth. The "ground truth" for its performance is established through standardized engineering and biological tests, not expert consensus on data interpretation.

4. Adjudication method for the test set

This information is not applicable as the device is not an AI/ML algorithm that involves human interpretation 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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical grasping forceps.

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

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized testing methodologies as referenced in the performance data section (e.g., ISO standards for biocompatibility, sterilization, packaging, and specific mechanical tests like insertion force, grasping performance, and strength testing). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML validation for this type of medical device.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm.

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The Rescue™ Pulmonary Grasping Forceps are intended to retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.

The Rescue™ Pulmonary Grasping Forceps is sterile, single-use devices. The Rescue™ Pulmonary Grasping Forceps can retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.

The Rescue™ Pulmonary Grasping Forceps is composed of thumb ring, spool and sliding handle at proximal end and the middle section of the Rescue™ Pulmonary Grasping Forceps is flexible shaft with a working length of 120 cm that connects with the distal end jaw assembly with an inner jaw opening of 4.5 mm. The Rescue™ Pulmonary Grasping Forceps is designed to pass through a 2.0 mm or greater working channel of a bronchoscope.

To operate the device, the user slides the spool back and forth over the handle body to open and close the iaws. The spool simultaneously actuates the pull wire which runs the length of the device and terminates with a connection to the jaws. Using Rescue™ Pulmonary Grasping Forceps the users can grasp excised tissue or foreign body by opening and then closing the jaws. The users can then retrieve the excised tissue or foreign body by pulling the Rescue™ Pulmonary Grasping Forceps with bronchoscope out of patient.

The provided text is a 510(k) Pre-market Notification for a medical device called "Rescue™ Pulmonary Grasping Forceps." This document details the device's characteristics, intended use, and performance data to establish substantial equivalence to a predicate device.

However, the document does not contain the information requested regarding acceptance criteria and study details for an AI-enabled medical device. The "Rescue™ Pulmonary Grasping Forceps" is a physical medical instrument, and the performance data described relates to its physical and material properties, not an AI algorithm.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria for an AI algorithm.
• Device performance in terms of AI metrics (e.g., sensitivity, specificity).
• Sample sizes for test sets in an AI study.
• Data provenance for AI training or testing.
• Number or qualifications of experts for AI ground truth.
• Adjudication methods for AI test sets.
• MRMC comparative effectiveness study for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth for an AI algorithm.
• Sample size or ground truth establishment for an AI training set.

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This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the nasal lumens and airway anatomy (including nasopharynx and trachea).

This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the airways and tracheobronchial tree.

The subject device is single-use grasping forceps sterilized by Ethylene Oxide.

The subject device consists of the Handle and the Insertion portion. The Insertion portion consists of the Distal end and the Sheath portion. The Handle consists of the Body and the Slider.

The subject device, after inserted into an endoscope from the Distal end, is used to grasp a foreign body or resected tissue with a pair of forceps (the Grasping jaws) at the Distal end by operating the Handle. The foreign body or the resected tissue is retrieved by removing the subject device together with the endoscope from the patient.

This document is a 510(k) summary for Single Use Grasping Forceps. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, the document does not contain information about a study that proves the device meets acceptance criteria in the way requested in the prompt.

The "Performance Data" section (page 9 and page 10) outlines several types of tests conducted:

• Sterilization/Shelf life testing: Conducted according to FDA guidance and ASTM F1980-16.
• Biocompatibility testing: Conducted according to ISO 10993-1, including cytotoxicity, intracutaneous, sensitization, and acute systemic toxicity studies.
• Performance testing - Bench: Included tests for insertability, grasping jaw operation, grasping performance, withdrawal property, device reliability, burr/edge, strength of junction, and breakage tolerance.
• Risk management: Performed according to ISO 14971:2007.

The document states that "design verification tests and their acceptance criteria were identified and performed as a result of this risk management" and that "Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness compared to the predicate devices."

However, none of the requested specific details for a study are provided within this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document summarizes categories of tests but doesn't list specific acceptance criteria or quantitative performance results.
2. Sample size used for the test set and the data provenance: Not provided for any of the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read studies or ground truth establishment are specified. The tests are bench and lab-based.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (forceps), not an AI/imaging algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/algorithm device.
7. The type of ground truth used: For the bench and lab tests, the "ground truth" would be the engineering specifications and established biological safety limits.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm device that uses a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document indicates that various non-clinical bench and laboratory tests were performed to demonstrate substantial equivalence to predicate devices and ensure safety and effectiveness according to established standards. However, it does not provide the detailed study information (e.g., sample sizes, specific acceptance criteria values, performance metrics) that would be expected for an AI/algorithm performance study.

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Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.

The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.

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

This information is not applicable. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.

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

This information is not applicable, as the study is not based on expert adjudication of clinical findings.

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 applicable. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.

8. The sample size for the training set:

This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.

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

This information is not applicable for the same reason as point 8.

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Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.

The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope.

The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.

The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.

The provided document is a 510(k) summary for the Micro-Tech Grasping Forceps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it explicitly states:

"8. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria for a clinical study and the study proving the device meets those criteria, as requested, cannot be provided because no clinical study was conducted or presented in this document.

The document does include a "Non-Clinical Test Conclusion" which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."

Here's the relevant information about the acceptance criteria and non-clinical testing from the document:

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

The document does not provide a table with explicit acceptance criteria for performance in a clinical setting. Instead, it relies on non-clinical tests to demonstrate that the device complies with various standards, thereby showing it meets design specifications and is substantially equivalent to a predicate device.

2. Sample sized 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 sample sizes for each non-clinical test. The provenance of the data is implicitly from Micro-Tech (Nanjing) Co., Ltd. in Jiangsu Province, PRC, as they are the submitter of the 510(k). The tests are non-clinical (laboratory/bench tests), not human clinical data, so the retrospective/prospective and country of origin for patients are not applicable.

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 "ground truth" for non-clinical tests is compliance with published international and national standards, not expert consensus interpreting clinical data. Therefore, no experts for establishing ground truth in the context of clinical performance are mentioned.

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

Not applicable, as this refers to clinical data adjudication, which was not performed.

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. No clinical studies, MRMC studies, or AI components are mentioned in the document.

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

Not applicable. No algorithm or AI component is mentioned.

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

For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., ASTM, ISO, USP). For the claim of Substantial Equivalence, the "ground truth" is that the device's technical characteristics, intended use, and performance (as shown through non-clinical testing) are sufficiently similar to the predicate device, and it raises no new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI or machine learning component.

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

Not applicable. No training set or ground truth for a training set is mentioned.

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The Endo-Therapeutics Laparoscopic Surgical Instruments are a line of reusable general surgical forceps, graspers and scissors intended to be used for lifting, dissecting, cutting organs and tissue during general open and laparoscopic procedures.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them. The document is an FDA 510(k) clearance letter for "Endo-Therapeutics Laparoscopic Instruments," indicating that the device has been found substantially equivalent to a predicate device. It specifies the product's intended use but does not detail any performance studies, acceptance criteria, or ground truth establishment. Therefore, I cannot extract the requested information.

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Used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).

The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are composed of a reusable handle and shaft assembly and a removable tip assembly. These instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures.

I am sorry, but based on the provided text, there is no detailed information about the acceptance criteria or a specific study proving the device meets those criteria.

The document is a 510(k) premarket notification for "Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders." It states that:

• "All materials used in the composition of the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable." (Page 1, "Summary of Testing")

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
5. Whether a standalone (algorithm only) performance study was done.
6. The type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

This document serves as an FDA clearance letter and a summary of substantial equivalence to a predicate device, rather than a detailed technical report of device performance testing.

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The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

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The provided text is a 510(k) summary for the OLYMPUS BIPOLAR FORCEPS. It focuses on regulatory approval and substantial equivalence to predicate devices. Crucially, this document does not contain any information regarding specific acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically includes a general statement of intended use and a comparison to predicate devices, but it does not usually elaborate on detailed performance studies, acceptance criteria, or ground truth establishment.

To answer your request, I would need a document that describes the specific testing and validation performed for the device's performance, which is not present in this 510(k) summary.

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The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.

The forceps are made of medical grade stainless steel, teflon coated medical grade stainless steel, black chrome plating, and plastic. The grasping forceps have been insulated and now allow the application of high frequency current.

The provided text is a 510(k) summary for the RICHARD WOLF Unipolar HF Grasping Forceps. It details the device, its intended use, and the basis for its substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study performance, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document states:

• "5.0 Performance Data None"
• "6.0 Clinical Tests No clinical tests performed."

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, and performance data, as this information is explicitly stated as not being included in the submission. The device's clearance was based on substantial equivalence to existing predicate devices, rather than through a performance study against specific acceptance criteria.

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The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.

The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.

The provided text is a summary of safety and effectiveness for grasping forceps (K970489) and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/algorithm performance. It primarily focuses on the regulatory submission details for a medical device (grasping forceps) in 1997, comparing it to a legally marketed substantially equivalent device.

Therefore, I cannot extract the requested information based on the provided input. The document describes a medical device and its intended use, rather than a study evaluating device performance against acceptance criteria using expert-reviewed data.

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