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These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.

The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) is a sterile, single-use device. The RJ4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8 mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0 mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length, and are offered in Box 5 and Box 20 packaging configurations.

To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

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The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.

The Radial Jaw 14 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use devices. The Radial Jaw'14 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

The provided text does not describe a study involving a device that uses artificial intelligence (AI) or machine learning.

Instead, the document is a 510(k) summary for a medical device called the "Radial Jaw™ 4 Pulmonary Biopsy Forceps." This device is a sterile, single-use instrument designed to collect tissue endoscopically for histologic evaluation. The submission specifically focuses on a modified handle design compared to a previously cleared predicate device.

The "Performance Data" section explicitly states: "Bench Testing has been performed on the proposed Radial Jaw™ 4 Pulmonary Biopsy Forceps to demonstrate that the modified handle design met the required specifications for the completed tests." This indicates traditional engineering bench testing, not a clinical study involving human readers, AI algorithms, or the kind of acceptance criteria typically associated with AI device performance.

Therefore, I cannot provide the requested information regarding:

• Table of acceptance criteria and reported device performance (in the context of AI)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth (in the context of AI)
• Sample size for the training set
• How ground truth for the training set was established

The document details a regulatory submission for a conventional medical instrument where "performance data" refers to its mechanical and functional specifications.

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The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.

The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use (disposable) devices. The devices are packaged in a tyvek pouch, which is packaged into a carton box. The Radial Jawns 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle, The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jav. The dual pull wire design allows the javs to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

This 510(k) pertains to a medical device, specifically the Radial Jaw™ 4 Pulmonary Biopsy Forceps, not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, sterilization, and various bench tests.

Here's an analysis based on the provided document, addressing the relevant points and noting where AI/ML specific criteria do not apply:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document implies that the acceptance criteria for the bench tests were specific design specifications, which the device "met." For biocompatibility, "passed" indicates meeting the requirements of the standards. For sterilization, achieving a Sterility Assurance Level (SAL) of 10⁻⁶ is the standard criterion.

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

• Test Set (for performance evaluation): The document does not specify exact sample sizes for each bench test conducted on the device. It states "In-vitro testing has been performed on the finished Radial Jaw™ 4 Pulmonary Biopsy Forceps device" and "bench tests were conducted on the RJ4 Pulmonary Biopsy Forceps." It's common for medical device bench testing to involve a representative number of units to ensure consistency and reliability, but specific counts are not provided here.
• Data Provenance: The testing appears to be internal "in-vitro" and "bench tests," conducted by the manufacturer, Boston Scientific Corporation. There is no mention of data from external sources, different countries, or retrospective/prospective clinical data for performance assessment in this 510(k) submission, as it relies on substantial equivalence through design and bench testing.

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

• Not Applicable (N/A) / Not provided: For a physical medical device undergoing bench and biocompatibility testing, "ground truth" as typically defined for AI/ML algorithms by expert consensus is not relevant. The "truth" is established by adherence to engineering specifications, recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization), and functional performance measured against predefined criteria. The experts involved would be qualified engineers, material scientists, and microbiologists conducting the tests and evaluating the results against established standards. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation of data is required to establish ground truth or resolve discrepancies, particularly for AI/ML outputs. Since this 510(k) references bench testing and compliance with standards for a physical device, an adjudication method in this sense is not relevant. The pass/fail criteria for each test are typically objective and determined by predefined laboratory protocols and specifications.

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: An MRMC comparative effectiveness study is not relevant here. This is a submission for a physical medical device (biopsy forceps), not an AI-powered diagnostic or assistive technology. No human readers or AI assistance are involved in the function or evaluation of the device as described in this summary.

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

• Not Applicable: This is not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is inherently "standalone" in that it performs its function (collecting tissue) without computational human-in-the-loop assistance.

7. The type of ground truth used

• Engineering Specifications, International Standards, and Functional Performance: For this device, the "ground truth" or reference for evaluating its performance is based on:
  • Design Specifications: Quantitative and qualitative requirements defined by Boston Scientific for the device's physical and functional characteristics (e.g., jaw volume, jaw opening, alignment, forces, robustness, etc.).
  • International Standards: Adherence to established standards for biocompatibility (EN ISO 10993-1: 2009) and sterilization (EN ISO 11137-1:2006 and EN ISO 11137-2:2006).
  • Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices (Radial Jaw™ II and Radial Jaw™ 3 Pulmonary Biopsy Forceps) to demonstrate substantial equivalence.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set. The device is manufactured according to a design, and then tested for compliance.

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

• Not Applicable: As this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set. The 'ground truth' pertinent to this submission relates to the validation of the device's design, manufacturing, and safety against established engineering principles and regulatory standards.

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Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.

Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles.

Here's a breakdown of the acceptance criteria and study information for the Ballard Reusable Bronchial Biopsy Forceps, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets for each test. Instead, it describes various tests performed and implies that the device met the necessary performance for substantial equivalence. The "reported device performance" is primarily qualitative, stating that the device passed the tests.

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

The document does not provide details on the sample size for the test set used in the functional, sterilization, reprocessing, or tensile equivalence tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The studies conducted are primarily engineering/performance tests (functional, sterilization, reprocessing, tensile) directly comparing the device to a predicate, not clinical studies requiring expert ground truth for interpretation of observational data.

4. Adjudication Method (for the test set)

This information is not applicable as the tests performed are not clinical trials requiring adjudication of expert interpretations but rather performance tests against defined specifications or predicate device characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing against a predicate device.

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

This question is not applicable as the device is a physical medical instrument (biopsy forceps), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be:

• Performance Specifications/Benchmarks: For functional tests, this would be the expected performance of a biopsy forceps.
• Predicate Device Characteristics: For sheath length, diameter, jaw geometry, and reprocessing parameters, the Olympus FB Series Biopsy Forcep (K962555) served as the direct comparator for substantial equivalence.
• Established Industry Standards/Protocols: For sterilization, reprocessing, and tensile strength, the tests would have been performed according to accepted methods to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not a learning algorithm or AI model that requires a training set.

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

This question is not applicable for the same reason as above.

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