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The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

• Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
• Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
• Models equipped with temperature thermistors can monitor intracranial temperature.
• Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

• Device Identification: Listing all device names, regulation numbers, classification, and product codes.
• Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
• Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
• MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

• A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
• The reported device performance metrics against those criteria.
• Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
• Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for test set: Not provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
• Data provenance: Not provided. The MR safety tests are likely laboratory-based.

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)

• Not applicable/Not provided. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

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

• Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

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

• For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
• For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

• Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

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

• Not applicable.

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The Cora Microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions of diagnostic contrast.

The CoraFlex and CoraForce Microcatheters (Cora Microcatheters) are single lumen catheters designed to access the peripheral and coronary vasculature. Each configuration has a hydrophilic coated coiled catheter with a braided support matrix, radiopaque distal tip, proximal luer, and "spin-friendly" strain relief. The Cora Microcatheters will also allow for the exchange of guidewires and provide a conduit for delivery diagnostic or therapeutic agents.

This document is a 510(k) clearance letter for medical microcatheters, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and expert involvement for AI device performance is not applicable to this submission.

The FDA clearance is based on non-clinical (bench) testing demonstrating substantial equivalence to a predicate device, as indicated by the following sections:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format. The document states:
"The Cora Microcatheters met all specified criteria and did not raise new questions regarding safety and effectiveness compared to the predicate."
And
"Based on the performance testing, the Cora Microcatheters were found to be substantially equivalent to the predicate."

The specific criteria and direct performance metrics are not detailed in this summary, but the types of tests performed indicate the areas of performance evaluated:

• Simulated Use
• Dimensional Verification
• Radiopacity
• Leak Testing
• Kink Resistance
• Corrosion Resistance
• Component Integrity
• Bond Integrity
• Particulate Testing
• Torque Testing
• Burst Testing
• Lubricity and Coating Integrity Testing
• Design Validation/Usability
• Sterility Testing
• Biocompatibility Assessment

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not explicitly stated in the provided document. The study was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-clinical device clearance.

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, as this is a non-clinical device clearance and does not involve AI or human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-clinical device clearance and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device would be established by engineering specifications and industry standards for medical device performance, as evaluated through bench testing.

8. The sample size for the training set:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

9. How the ground truth for the training set was established:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

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The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 μg/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/ml of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Sulbactam- Durlobactam at concentrations of 0.004/4-64/4 μg/ml should be interpreted at 16-20 hours of incubation.

Testing with MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 μg/mL is indicated for Acinetobacter baumannii calcoaceticus complex as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The MTS Sulbactam-Durlobactam 0.004/4-64/4 μg/mL has demonstrated acceptable performance with the following organisms:

Acinetobacter baumannii calcoaceticus complex

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient sulbactam across 15 two-fold dilutions like those of a conventional MIC method and durlobactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the sulbactam-durlobactam code (SUD) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.

Sulbactam-durlobactam is an intravenous beta-lactam combination antibiotic used to treat hospital-acquired pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.

Here is a description of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the MTS Sulbactam-Durlobactam device:

Device: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
Intended Use: Quantitative method for in vitro determination of antimicrobial susceptibility of Acinetobacter baumannii calcoaceticus complex using MIC Test Strips with manual reading after overnight incubation.

1. Acceptance Criteria and Reported Device Performance

The study evaluated the performance of the MTS Sulbactam-Durlobactam device against a reference broth microdilution MIC method. The primary metrics for performance were Essential Agreement (EA) and Category Agreement (CA), along with an analysis of errors (very major, major, minor). While explicit "acceptance criteria" percentages are not directly stated in the summary, typical FDA criteria for AST systems are implied by the reported results. The guidance document referenced "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, August 28, 2009" would contain the specific acceptance thresholds. Based on the provided summary, the device performance is reported as follows:

Table of Device Performance

Implied Acceptance Criteria (based on typical FDA AST requirements, generally >90% for EA and CA, and strict limits on major/very major errors):
The reported performance values of 97.3% EA and 92.7% CA, along with very low major errors and zero very major errors, indicate that the device met the acceptance criteria as determined by the FDA. Specifically, the zero very major errors are critical for patient safety, as they avoid situations where a resistant infection might be incorrectly identified as susceptible, leading to inappropriate treatment.

2. Sample Size and Data Provenance

• Test Set Sample Size: 588 isolates for the combined clinical and challenge organism groups.
• Data Provenance:
  • Clinical Testing: Performed at three (3) sites. The precise country of origin is not explicitly stated for the clinical sites, but the submitter (Liofilchem s.r.l.) is based in Italy, and their contact person for the 510(k) is in Westlake, Ohio, USA. The FDA clearance suggests testing was appropriate for the US market.
  • Challenge Isolate Testing: Performed at one site (Laboratory Specialists, Inc., which is the 510(k) preparer's company in Westlake, Ohio).
  • Nature of Data: The data combines retrospective (challenge isolates specifically selected to ensure MIC range coverage, including resistant isolates) and prospective (fresh clinical isolates tested at multiple sites) elements.

3. Experts Used for Ground Truth and Qualifications

This section does not directly apply as the device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not an imaging AI device requiring expert interpretation of images. The "ground truth" for antimicrobial susceptibility is established by a standardized laboratory method (broth microdilution) rather than human expert consensus on subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, etc.) are typically used in studies involving human interpretation or subjective assessments. For this AST device, the ground truth is established by a quantitative, objective laboratory method (CLSI broth microdilution guidelines). Therefore, no human adjudication method was employed for establishing the ground truth of the MIC values. Minor discrepancies or errors between the device and the reference method are simply categorized as such (major, minor, very major errors).

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

An MRMC study is not applicable to this type of device. The MTS Sulbactam-Durlobactam is a manual antimicrobial susceptibility test system that determines the MIC directly. It is not an AI-assisted diagnostic imaging system where human readers interpret data with or without AI assistance. The performance is assessed by comparing the device's MIC readings to a gold standard laboratory method, not by comparing human reader performance.

6. Standalone (Algorithm Only) Performance

This concept is applicable, and the study provided details on the standalone performance of the MTS Sulbactam-Durlobactam device. The "performance data" table (Essential Agreement, Category Agreement, and Error Rates) directly refers to the device's ability to accurately determine MIC values and susceptibility categories when compared to the reference method, essentially its "algorithm-only" performance in the context of an IVD. There is no "human-in-the-loop" component for interpretation; the user manually reads the MIC from the strip.

7. Type of Ground Truth Used

The ground truth used for this study was reference broth microdilution MIC method, conducted according to CLSI M7-A11 guidelines. This is a well-established and standardized laboratory method for determining antimicrobial minimum inhibitory concentrations, considered the gold standard for AST.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the development of the MTS Sulbactam-Durlobactam device. For IVDs like AST systems, the "training" typically refers to the initial development and optimization of the test strip's design, antimicrobial gradient, and manufacturing process to reliably produce specific drug concentrations and diffusion patterns. This is primarily a chemical and engineering development process, not a machine learning training process with a distinct data set. The 588 isolates discussed are for the performance validation (test set) rather than initial model training.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" and associated "ground truth establishment" in the machine learning sense are not described for this type of medical device. The "ground truth" for the performance validation was established by the CLSI broth microdilution reference method. For the initial development and optimization phase of such a device, the "ground truth" would implicitly be the accurate and precise measurement of drug concentration gradients and their biological effect on various bacterial strains, guided by established AST principles and drug properties.

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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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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural rubber latex male condom

This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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