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The EndoWrist Cobra Grasper instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.

The subject device is a remanufactured 420190 Cobra Grasper with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during and endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

The provided FDA 510(k) clearance letter (K250417) is for a remanufactured medical device, specifically a "Remanufactured EndoWrist Cobra Grasper (420190)". This context is crucial because the acceptance criteria and study design for remanufactured devices often focus on demonstrating that the remanufactured device performs identically to the original equipment manufacturer (OEM) device and that the remanufacturing process does not introduce new safety or efficacy concerns.

The document does not describe a traditional AI/ML model's acceptance criteria or a comparative effectiveness study in the typical sense (e.g., human reader improvement with AI). Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence for the remanufactured device to its predicate. The "study" mentioned is the set of tests performed to verify this equivalence.

Based on the provided text, here's a breakdown:

1. Acceptance Criteria and Reported Device Performance

For a remanufactured device, the acceptance criteria are generally met by demonstrating that the device's characteristics and performance are maintained or restored to be substantially equivalent to the original, legally marketed predicate device. The "reported device performance" is framed as the successful verification that no adverse changes were introduced by remanufacturing.

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

The document does not explicitly state a quantitative "sample size" for the test set in terms of number of devices or tests. Instead, it describes types of tests performed.

• Test Set Description: The "test set" here refers to the actual remanufactured devices that were subjected to various verification and validation tests (life testing, electrical safety, biocompatibility, reprocessing validation, cybersecurity assessment).
• Data Provenance: The data provenance is from tests conducted on the remanufactured devices themselves. The document states a "remanufactured EndoWrist ProGrasp Forceps (model: 420093, K241872) was used as a reference for the testing methods," implying internal testing methods or protocols were applied. There's no indication of clinical study (retrospective/prospective) data or country of origin for such data, as this is a remanufactured physical device, not an AI/software.

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

This concept (experts establishing ground truth for a test set) is typically relevant for interpretative tasks, such as in diagnostic AI where radiologists label images.
For a remanufactured physical medical device, "ground truth" is established by adherence to engineering specifications, performance standards, material analysis, and functional testing. Thus, there is no mention of "experts" in the sense of clinical readers establishing ground truth. The "experts" would be the engineers, material scientists, and quality assurance personnel conducting the tests and verifying compliance. Their qualifications are assumed to be appropriate for performing these engineering and scientific tests.

4. Adjudication Method for the Test Set

As this is not a diagnostic interpretation task, "adjudication method" in the sense of clinician consensus (e.g., 2+1, 3+1) is not applicable. The "adjudication" for a remanufactured device involves engineering verification and validation, quality control inspections, and adherence to specified test protocols and acceptance criteria outlined in the Quality System (21 CFR Part 820).

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

• Was an MRMC study done? No. The document does not describe an MRMC study.
• Effect Size of Human Readers Improvement with AI: Not applicable, as this is a physical medical device and not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• Was a standalone study done? Not applicable in the context of an AI algorithm. The closest equivalent is the performance of the remanufactured device itself during various bench and functional tests, which are conducted "standalone" from a human operator in terms of assessing the device's inherent physical properties and functionalities.

7. Type of Ground Truth Used

The "ground truth" for this remanufactured device is engineering specifications, performance standards, and material properties of the original OEM device. The goal of the study is to confirm that the remanufactured device meets these pre-defined engineering and safety standards, proving it is substantially equivalent to the original. This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical and functional testing.

8. Sample Size for the Training Set

• Sample size: Not applicable. This is a remanufactured physical device, not an AI/ML model that requires a "training set." The remanufacturing process is based on reverse engineering, repair, and refurbishment adhering to the original design specifications, not on learning from a data set.

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

• How established: Not applicable. As there is no training set for an AI/ML model, this question does not apply. The "ground truth" for the remanufacturing process itself is implicitly the design and performance specifications of the original OEM device, which are derived from engineering principles and validated through the original device's clearance.

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The EndoWrist Long Tip Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject device is a remanufactured 420048 Long Tip Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during an endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

The provided FDA 510(k) clearance letter for the Remanufactured EndoWrist Long Tip Forceps (K250387) primarily focuses on establishing substantial equivalence to a predicate device. This type of submission often relies more on non-clinical performance data and a comparison to an existing device rather than a comprehensive de novo clinical study with pre-defined acceptance criteria for an AI/CADe device.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/CADe devices (items 1-9) does not directly apply to this remanufactured medical instrument. The "study" described in this document is a non-clinical performance evaluation aiming to demonstrate that the remanufactured device performs equivalently to the original and does not introduce new safety or efficacy concerns.

However, I can interpret the available information to best fit the prompt's structure, focusing on the concepts of "acceptance" and "proof" as presented in this 510(k).

Here's an analysis based on the provided text, rephrasing where necessary to align with the spirit of the prompt's questions, while acknowledging the inherent differences for a remanufactured mechanical device vs. a typical AI/CADe submission:

Understanding "Acceptance Criteria" for a Remanufactured Medical Device

For a remanufactured device like the EndoWrist Long Tip Forceps, "acceptance criteria" are not typically expressed as sensitivity/specificity thresholds for diagnostic accuracy (as would be the case for AI). Instead, they are related to functional equivalence, safety, and durability compared to the original device. The "study" proving acceptance is a set of non-clinical tests and assessments demonstrating that the remanufactured device meets these criteria and poses no new risks.

The "Study" Proving Acceptance

The submission describes a comprehensive non-clinical performance evaluation rather than a human-in-the-loop clinical trial or a standalone algorithm performance study. The core of the "proof" revolves around showing that the remanufactured device maintains the same performance, safety, and durability characteristics as the original, legally marketed predicate device.

Detailed Information Based on the Provided Document:

1. Table of "Acceptance Criteria" (Interpreted) and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices (e.g., N=X remanufactured forceps were tested). Instead, the submission describes types of tests (life testing, electrical safety, biocompatibility, reprocessing validation, cybersecurity assessment) applied to the remanufactured device. It's implied that sufficient samples were tested to gain confidence in the established equivalence.
• Data Provenance: The data are non-clinical engineering and laboratory test results generated by the manufacturer (Rebotix) and/or their testing partners. The country of origin of the data is not specified, but the applicant and correspondent are US-based. This is neither retrospective nor prospective in the clinical sense, but rather lab-based validation.

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

• This question is not applicable in the traditional sense for a remanufactured mechanical instrument. "Ground truth" for an AI/CADe system is typically expert-labeled data.
• For this device, the "ground truth" for performance and safety is defined by the specifications and performance of the original, new predicate device. The "experts" involved would be the engineers, quality control personnel, and regulatory specialists who designed and executed the non-clinical tests and analyzed the results against established engineering standards and the predicate's performance. Their qualifications would be in engineering, materials science, electrical safety, biocompatibility, and quality assurance. Their exact number and specific qualifications are not detailed in this clearance letter.

4. Adjudication Method for the Test Set:

• Not applicable in the context of human reader consensus for AI performance.
• For mechanical testing, validation would involve comparison against predefined engineering specifications and performance benchmarks of the original device and relevant standards (e.g., IEC, ISO). Any deviations would likely be evaluated by a multidisciplinary team (engineering, quality, regulatory) within the manufacturer.

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

• No, an MRMC study was NOT done. This type of study is specifically designed to assess the impact of AI assistance on human reader performance, which is not relevant for a remanufactured surgical instrument.

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

• No, a standalone algorithm performance study was NOT done. This device is a mechanical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" is established through objective, measurable engineering parameters and performance characteristics of the predicate (original) device, as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety). It also includes adherence to the "Professional Instructions for Use" for the system it integrates with.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device. The remanufacturing process is a defined mechanical and chemical procedure, not an iterative learning process.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The EndoWrist Tenaculum Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject device is a remanufactured 420207 Tenaculum Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during and endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

While the provided FDA 510(k) clearance letter (K250539) details the clearance of a remanufactured medical device (Remanufactured EndoWrist Tenaculum Forceps), it does not contain information about an AI/ML-driven device or its performance criteria and study results.

The document discusses the substantial equivalence of the remanufactured forceps to a predicate physical device based on identical mechanical design, materials, and intended use. The "non-clinical and/or clinical tests" section refers to:

• Life testing: To verify performance and durability through additional uses.
• Electrical safety evaluation: Per IEC 60601-1.
• Biocompatibility testing: Per ISO 10993-1.
• Reprocessing validation: Per OEM instructions.
• Cybersecurity assessment: Per FDA Guidance on Cybersecurity in Medical Devices.

These tests are standard for remanufactured hardware devices to ensure they meet the same safety and performance standards as the original. They are not related to the type of performance evaluation (e.g., accuracy, sensitivity, specificity, reader studies) typically required for AI/ML-driven medical devices to prove their acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this specific document. The document pertains to a traditional physical medical device.

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The EndoWrist Cadiere Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject device is a remanufactured 420049 Cadiere Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during an endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

This FDA 510(k) clearance letter pertains to a remanufactured medical device, the Remanufactured EndoWrist Cadiere Forceps. Unlike typical AI/software device clearance documents, this document focuses on demonstrating substantial equivalence for a physical device that has undergone a process to extend its lifespan and enable additional uses. Therefore, it does not contain the typical information related to acceptance criteria, test set, ground truth establishment, or AI model training as one would find for an AI/ML-based device.

Based on the provided text, here's what can be extracted regarding the device's acceptance criteria and the study proving it meets them:

Core Reason for Clearance: The manufacturer is demonstrating that the remanufactured device performs equivalently to the original (predicate) device, especially given that its "use counter has been reset to permit an additional controlled set of uses." The acceptance criteria are implicitly tied to ensuring the remanufactured device maintains the safety and efficacy of the original.

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is a remanufactured physical device and not an AI/ML diagnostic tool, the "acceptance criteria" are not reported in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, they relate to the continued functional and safety performance of the remanufactured forceps.

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

• Test Set Sample Size: The document does not specify a numerical sample size for "life testing," "electrical safety evaluation," "biocompatibility testing," "reprocessing validation," or "cybersecurity assessment." These types of tests typically involve a defined number of units or cycles to statistically demonstrate compliance with performance specifications. However, the specific numbers are not disclosed in this summary.
• Data Provenance: The data comes from internal testing and assessments conducted by Rebotix (the manufacturer) or their designated testing facilities. There is no mention of external data sources, clinical study sites, or patient data (retrospective or prospective). The reference to K241872 (remanufactured EndoWrist ProGrasp Forceps) as a reference for testing methods suggests a consistent internal methodology.

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 for this type of device and submission. "Ground truth" in the context of AI/ML devices typically refers to the definitive determination of a condition (e.g., disease presence, lesion type) established by expert consensus or other definitive methods for labeling data. For a remanufactured physical device, "ground truth" is not established in this manner. Instead, performance is validated against established engineering and safety standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions, typically in AI/ML performance studies. This is not relevant for the engineering and safety tests conducted for a remanufactured 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 information is not applicable. An MRMC study is specific to evaluating the clinical performance of AI-assisted diagnostic tools and measuring the impact of AI on human reader performance. This submission is for a remanufactured surgical instrument, not an AI diagnostic system.

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

This information is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. This is not an AI/software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance validation is primarily based on:

• Established engineering specifications and performance benchmarks for the original (predicate) device.
• Compliance with international safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
• Validation against Original Equipment Manufacturer (OEM) instructions for reprocessing.
• Demonstrating that the remanufactured device behaves mechanically and functionally identically to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI/ML model. This is a remanufactured physical device, not an AI/ML model.

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

This information is not applicable for the same reasons as #8.

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