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510(k) Data Aggregation
(188 days)
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.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Form, Fit, and Function Equivalence | Demonstrate identical design, material, chemical composition, principles of operation, energy source, and host system compatibility as the predicate OEM device. | "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." "The remanufactured Cobra Graspers have the same technological characteristics including design, material, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device." |
| Intended Use & Indications for Use | Maintain the exact same indications for use as the predicate OEM device. | "There are no changes to the claims, intended use, clinical applications, patient population, or method of operation." "The indications for use of the remanufactured Cobra Grasper is the same as the predicate OEM device." |
| Durability / Life Extension | Verify that the device can withstand additional controlled uses after remanufacturing. | "The use counter has been reset to permit an additional controlled set of uses." "Life testing to verify device performance and durability through additional uses" was performed. |
| Electrical Safety | Compliance with relevant electrical safety standards. | "Electrical safety evaluation (per IEC 60601-1)" was performed. |
| Biocompatibility | Demonstrate that remanufactured materials remain biocompatible. | "Biocompatibility testing (per ISO 10993-1)" was performed. |
| Reprocessing Validation | Validate that the device can be reprocessed according to OEM instructions. | "Reprocessing validation (per OEM instructions)" was performed. |
| Cybersecurity (if applicable) | Address potential cybersecurity risks introduced or affected by remanufacturing. | "Cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices)" was performed. |
| Safety and Efficacy Equivalence | Demonstrate that no different questions of safety or efficacy are raised compared to the predicate. | "Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Cobra Grasper is demonstrated to be substantially equivalent to the predicate devices, with no different questions of safety or efficacy having been raised." |
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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(189 days)
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:
| Acceptance Criteria (Interpreted for Remanufactured Device) | Reported Device Performance (Summary from Text) |
|---|---|
| Functional Equivalence: Mechanism of action and principles of operation are identical to the predicate device. | "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." "The remanufactured Long Tip Forceps have the same technological characteristics including design, material, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device." |
| Durability / Life Extension: Ability to withstand additional controlled uses without performance degradation. | "Life testing to verify device performance and durability through additional uses" was performed. The "use counter has been reset to permit an additional controlled set of uses." (Implies successful completion of this testing). |
| Electrical Safety: Compliance with relevant electrical safety standards. | "Electrical safety evaluation (per IEC 60601-1)" was performed. (Implies compliance). |
| Biocompatibility: No adverse biological reactions. | "Biocompatibility testing (per ISO 10993-1)" was performed. (Implies compliance). |
| Reprocessing Validation: Ability to be reprocessed effectively per OEM instructions. | "Reprocessing validation (per OEM instructions)" was performed. (Implies successful validation). |
| Cybersecurity: Assessment of cybersecurity risks (if applicable to device control system). | "Cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices)" was performed. (Implies identified risks were addressed, though the forceps alone are unlikely to have complex cybersecurity needs, it's tied to the control system). |
| No New Safety/Efficacy Questions: Demonstration that remanufacturing does not introduce new concerns. | "Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Long Tip Forceps is demonstrated to be substantially equivalent to the predicate devices, with no different questions of safety or efficacy having been raised." |
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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(176 days)
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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(189 days)
The Endo Wrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X Surgical System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000 and da Vinci Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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, 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. 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 da Vinci X/Xi 8 mm monopolar scissors instrument (470179) is used in conjunction with its intended surgical robot for cutting, cauterizing, coagulation, manipulating and blunt dissue. This instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axis of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.
Endo Wrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision in a minimally invasive environment. EndoWrist instruments, in conjunction with the applicable surgical robot, are designed to support rapid and precise suturing, dissection, and tissue manipulation in surgical procedures.
The design, materials, and intended use of the Reusable Surgical Instruments, after an additional ten (10) reuse cycles, are substantially equivalent to the predicate device in form, fit, and function. The reusable device is identical to the predicate device in that the same standard mechanicals, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
The provided text is a 510(k) premarket notification for a medical device: an 8mm Monopolar Curved Scissors (470179) for use with the da Vinci Xi/X Surgical System. The notification states that the device is a remanufactured/reprocessed version of an existing device, increasing its usability from 10 to 20 cycles through a refurbishment process.
The document discusses acceptance criteria and testing, but not in the context of an AI-powered diagnostic or assistive technology. Instead, the acceptance criteria and study described relate to the safety and effectiveness of the remanufactured physical surgical instrument itself.
Therefore, most of the requested information regarding AI device performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) is not applicable to this submission.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Tests Performed) | Reported Device Performance / Conclusion |
|---|---|
| Biocompatibility | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Functional Performance Testing | Concluded that the reprocessed devices are as safe and effective as the predicate and operate as originally intended. |
| Bioburden, Cleaning, and Bacterial Endotoxins | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Electrical Safety | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Validation of Reprocessing | Implicitly met, as performance testing demonstrates reprocessed devices are safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "design verification and design validation testing." This typically involves testing a representative number of units, but the specific count is not provided.
- Data Provenance: Not applicable in the context of clinical data for an AI device. The data comes from laboratory and engineering testing of the physical remanufactured surgical instruments. The country of origin of the data is not specified, but it would be from the manufacturer's testing facilities. The tests are prospective in nature, as they are conducted on the remanufactured devices to prove their performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is objective physical and electrical properties, and biological safety, measured through standardized tests, not expert interpretation of medical images or data. Engineering and quality control personnel would be involved in conducting and evaluating these tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for expert consensus on subjective assessments. The tests described are objective and rely on measurement against predefined 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. This device is a physical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a remanufactured physical surgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this device's acceptance is based on predefined engineering specifications, material properties, electrical safety standards, and biocompatibility requirements, as well as the performance characteristics of the predicate device. It's objective, measurable criteria from a combination of regulatory standards and the original device's design.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary: The provided FDA submission for the 8mm Monopolar Curved Scissors focuses on demonstrating the substantial equivalence and safety/effectiveness of a remanufactured physical surgical instrument. The acceptance criteria and studies are related to the physical, electrical, and biological performance of this instrument, not to the performance of an AI algorithm.
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(133 days)
The EndoWrist ProGrasp 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, 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 pediatic 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 420093 ProGrasp 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, dinical applications. patient population, or method of operation.
This document is an FDA 510(k) clearance letter for a remanufactured medical device. It does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. The document explicitly states that the device is a remanufactured mechanical component (EndoWrist ProGrasp Forceps) and its substantial equivalence to a predicate device is based on "no modification to the mechanical design, materials, or dimensions." There is no mention of AI, algorithms, or any form of software performance evaluation in this document.
Therefore, I cannot provide the requested information from the provided text.
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(588 days)
The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection 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, 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 placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral procedures restricted to benign and malignant tumors classified as Tl 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 sicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System),
The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile.
8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.
The provided text is related to the FDA 510(k) clearance for the "8mm Monopolar Curved Scissors" and discusses its substantial equivalence to predicate devices. However, it does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
The document focuses on the physical medical device (surgical scissors) and its continued substantial equivalence after an extended useful life (additional 10 reuse cycles). The "Performance Data" section lists various engineering and safety tests typical for a surgical instrument, such as Biocompatibility, Validation of Reprocessing, Functional Performance Testing, and Electrical Safety Testing. These are not performance metrics for an AI/ML algorithm.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because the document describes the clearance of a non-AI/ML physical medical device.
To answer your request, the input document would need to be a 510(k) summary (or similar regulatory document) for an AI/ML-driven medical device, which would typically include sections on algorithm performance, clinical validation studies, and the establishment of ground truth for AI model evaluation.
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