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The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra Sterilization Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:

Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes

Vacuum Dry: 20 minutes

The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:

One (1) iDrive™ Ultra powered handle

Two (2) Endo GIA™ adapters

Two (2) iDrive™ battery insertion guides

One (1) iDrive™ Ultra manual adapter tool

The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.

Here's an analysis of the provided text regarding the iDrive™ Ultra sterilization tray, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a new clinical study. As such, information regarding AI performance metrics (like sensitivity, specificity, F1 score), sample sizes for AI training/testing, expert qualifications, and MRMC studies will not be present as this device is a physical sterilization tray, not an AI diagnostic or assistive tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

Due to the nature of the device (a physical sterilization tray) and the document (510(k) Summary), this information is not applicable in the context of an AI/algorithm test set. The "test set" here refers to the actual physical trays and associated sterilization equipment used for physical, performance-based testing.

• Sample Size: Not explicitly stated as a number of "samples" in the way an AI study would define it. The testing involved multiple sterilization cycles and evaluations on the physical device. Typically, for such devices, a statistically significant number of cycles or tests are performed (e.g., n=3 for replicates, or stress testing until failure for durability), but the exact numbers are not detailed in this summary.
• Data Provenance: Not explicitly stated. The testing would have been conducted by Covidien, LLC, likely in their own laboratories or through contract labs. It's prospective testing for the purpose of this submission.
• Country of Origin: Not specified for the testing itself, but the submitter is Covidien LLC from North Haven, CT, USA.

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

This is not applicable as the device is a physical sterilization tray, not an AI system requiring expert-derived ground truth. The "ground truth" for sterilization effectiveness would be determined by objective measures (e.g., biological indicators, chemical integrators, sterility assays, temperature/pressure monitoring) according to validated protocols, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert ratings are resolved for diagnostic classifications, which is irrelevant for a sterilization tray.

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 is a physical medical device, not an AI-assisted diagnostic tool.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance of a sterilization tray involves objective, verifiable outcomes related to sterilization efficacy and device integrity:

• Sterilization Efficacy: Achieved by passing established sterilization cycle parameters (temperature, pressure, time, vacuum dry time) and demonstrated sterility through biological indicators (killing of spore-forming bacteria), chemical indicators (color change), and physical monitoring of the autoclave cycle.
• Material Compatibility: Demonstrated by conformity to ISO 10993-1.
• Durability/Reusability: Demonstrated by the tray's physical integrity and functional performance after repeated sterilization cycles.
• Containment/Organization: Demonstrated by the physical fit of the specified components within the tray.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary of the Study Proving Device Meets Acceptance Criteria (from the 510(k) Summary):

The document states: "PERFORMANCE DATA: Testing has been performed and includes testing to the following standards: - ANSI/AAMI ST77:2006 - AAMI TIR30:2003 ."

These standards are critical for sterilization practices and medical device material compatibility, respectively:

• ANSI/AAMI ST77:2006 (or its current version): This standard typically covers "Containment devices for reusable medical device sterilization." It would detail requirements and test methods for instrument trays, wrappers, and containers regarding their ability to facilitate sterilization, prevent recontamination, and withstand reprocessing.
• AAMI TIR30:2003 (or its current version): This Technical Information Report (TIR) from AAMI focuses on "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices." While the tray itself isn't a "reusable medical device" in the same sense as an instrument, this TIR often provides guidance on material compatibility and resistance to reprocessing methods, including sterilization.

Implicit Study Design:

The "study" would involve:

1. Preparation: Loading the iDrive™ Ultra sterilization tray with the specified maximum configuration of instruments/components.
2. Sterilization Cycles: Running the loaded tray through the specified prevacuum steam cycles (132°C for 4 minutes and 134°C for 3 minutes, both with a 20-minute vacuum dry time) in a validated autoclave, likely using an FDA-cleared sterilization wrap.
3. Sterility Assurance: Monitoring the sterilization cycle parameters, and using biological and chemical indicators to confirm that sterility was achieved within the tray.
4. Material Compatibility/Integrity: Visual and functional inspection of the tray and its components after multiple sterilization cycles to ensure no degradation, melting, warping, or other adverse effects that would compromise its function or the sterility of the contents.
5. Biocompatibility: Evidence of compliance with ISO 10993-1, likely through material certificates and prior evaluations of the silicone and aluminum materials.
6. Load Capacity Testing: Demonstrating that the tray can safely support 15 pounds without structural failure.

The "acceptance criteria" are implied by the successful completion of these tests in accordance with the cited standards and the stated operational parameters for the device. The conclusion of the 510(k) is that, based on this testing and comparison to predicate devices, the iDrive™ Ultra sterilization tray is substantially equivalent and safe and effective for its intended use.

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The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and reseation of pancreas.

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with the Endo GIA™ Radial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

This 510(k) introduces an accessory to the iDrive™ Ultra powered handle and Endo GIA™ adapter system (K121510), the iDrive™ Ultra reusable manual adapter tool. The iDrive™ Ultra reusable manual adapter tool is a reusable, handheld device that can be used to operate an Endo GIA™ adapter manually. It can be used to complete a firing, retract the knife and open the jaws, and to articulate an Endo GIA™ reload. The "manual tool" is not intended to initiate a reload firing. It is intended to provide the user with a manual method of operating the reload.

In addition. this premarket notification reports non-significant changes made to the iDrive™ Ultra powered handle and Endo GIA™ adapter (K121510) since their clearance in July 2012. At the time of their implementation, these changes did not necessitate a 510(k) notification. These changes are described in this 510(k) according to the FDA Draft Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)".

The provided text describes a 510(k) premarket notification for a surgical stapler system accessory, the iDrive™ Ultra reusable manual adapter tool, and non-significant changes to the iDrive™ Ultra powered handle and Endo GIA™ adapter. However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in terms of quantitative performance metrics.

The document states: "Verification and validation activities were performed and these activities are described in Section 11: Declarations of Conformity and Summary Reports. These evaluations demonstrate that the iDrive™ Ultra reusable manual adapter tool, and the iDrive™ Ultra system as a whole, functions as intended." Unfortunately, "Section 11: Declarations of Conformity and Summary Reports" is not included in the provided text.

Based on the information given, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, sample sizes, expert involvement, or ground truth.

Here's what can be extracted:

• Device Name: iDrive™ Ultra reusable manual adapter tool (accessory) and iDrive™ Ultra powered handle and Endo GIA™ adapter (system).
• Intended Use: The manual adapter tool is for operating an Endo GIA™ adapter manually, completing a firing, retracting the knife, opening jaws, and articulating a reload. It is not intended to initiate a reload firing or for patient contact.
• Safety: The manual adapter tool is comprised of materials that are in accordance with ISO 10993-1.

Regarding your specific points, based only on the provided text:

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

   • Cannot be provided. The document states "Verification and validation activities were performed" and "These evaluations demonstrate that... [the device] functions as intended," but it does not list specific measurable acceptance criteria or their corresponding performance results.

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

   • Cannot be provided. This information is not present in the document.

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

   • Not applicable / Cannot be provided. There is no mention of a test set with human-established ground truth in this type of mechanical device submission. The verification/validation would likely involve engineering tests, functional tests, and material biocompatibility tests.

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

   • Not applicable / Cannot be provided. This concept is generally relevant for AI/diagnostic devices where human interpretation is critical for ground truth, not for the functional testing of a mechanical surgical stapler.

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 document describes a mechanical surgical device and an accessory, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" improving with "AI assistance" are not relevant to this submission.

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

   • Not applicable. This is a mechanical device, not an algorithm.

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

   • Cannot be explicitly determined from the provided text. For mechanical devices, "ground truth" would typically refer to established engineering specifications, mechanical tolerances, material properties, and functional requirements. For example, a stapler's ground truth might be "all staples fire successfully," "staple formation meets specifications," or "clamping force is within tolerance." The text only vaguely refers to "functions as intended."

8. The sample size for the training set:

   • Not applicable / Cannot be provided. This device is not an AI/machine learning model, so there is no "training set" in that context.

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

   • Not applicable / Cannot be provided. As above, no training set for an AI model is involved.

In summary: The provided 510(k) summary focuses on device description, intended use, and substantial equivalence to a predicate device. It confirms that verification and validation activities were performed and demonstrated the device functions as intended, but it explicitly omits the details of those activities and their specific results, referring to an external "Section 11: Declarations of Conformity and Summary Reports" which is not included. This type of submission for a mechanical device typically does not involve the kinds of studies (e.g., MRMC, AI performance) that your detailed questions are tailored for.

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The iDrive ™ Ultra powered handle and En do GIA ™ adapter, when used with En do GIA ™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection rof liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.

The iDrive ™ Ultra powered handle and Endo GIA TM adapter, when used with Endo GIA TM curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The iDrive ™ Ultra powered handle and En do GIA TM adapter, when used with the Endo GIA TM Radial Reload with Tri-Staple ™ Technology, has applications in open or minimally invasive raneral abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Surgical stapler with a powered handle, delivering implantable titanium staples.

The provided submission describes a surgical stapler, the iDrive™ Ultra powered handle and Endo GIA™ adapter, and does not relate to an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on the safety and effectiveness of a physical medical device, not a software algorithm. The "Performance Data" section lists various in-vitro and in-vivo tests for the stapler's mechanical and biological properties, as well as adherence to electrical safety standards. This is typical for a traditional 510(k) submission for a non-AI device.

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iDrive™ Powered Handle: The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
iDrive™ RALC: The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Surgical stapler with Powered Handle, delivering implantable titanium staples. The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.

The provided document is a 510(k) summary for a surgical stapler system (iDrive™ System), which describes the device, its intended use, and performance data from in-vitro and in-vivo testing. However, it does not contain specific acceptance criteria values or detailed study results in numerical format that would directly enable me to fill out a table of acceptance criteria and reported performance with numerical values.

The document lists various performance tests conducted, but it doesn't provide the quantitative acceptance criteria for each test or the specific quantitative results achieved by the device against those criteria. For example, it lists "Staple line pull-apart strength test" but doesn't state what the minimum acceptable pull-apart strength was or what the device's measured pull-apart strength was.

Therefore, I cannot generate the table requested in point 1 or provide detailed answers to points 2, 3, 4, 5, 6, 7, 8, and 9 as they pertain to specific quantitative study outcomes and methodologies that are not present in this summary.

Based on the information provided in the 510(k) summary, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available in Document: The document lists various performance tests but does not provide specific numerical acceptance criteria or the quantitative results achieved by the device for these tests. Therefore, a table with these details cannot be generated from the provided text.

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

Information Not Available in Document: The document mentions "In-vitro and in-vivo testing" but does not specify the sample sizes used for any of the tests listed (e.g., number of staple lines tested, number of animals in in-vivo studies, etc.). The provenance of the data (e.g., country of origin) is also not stated beyond being internal Covidien testing. The document is a regulatory submission, implying the studies were conducted by the manufacturer. Whether the studies were retrospective or prospective is not explicitly mentioned, but performance testing is typically prospective.

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

Information Not Available in Document: The document does not describe the use of human "experts" to establish ground truth in the context of these performance tests. These are engineering and biological performance tests, not diagnostic image interpretation.

4. Adjudication Method for the Test Set

Information Not Available in Document: Adjudication methods (like 2+1, 3+1) are relevant to situations where subjective interpretation or consensus among multiple human reviewers is required (e.g., clinical trials with expert readers assessing outcomes). This is not applicable to the engineering and biological performance tests described in the 510(k) summary.

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

Information Not Available in Document: An MRMC comparative effectiveness study, typically comparing human readers with and without AI assistance, is not mentioned. The device is a surgical stapler, not an AI or imaging diagnostic device where such studies are common.

6. Standalone (Algorithm Only) Performance Study

Information Not Available in Document: This question is relevant to AI algorithms. The device is a physical surgical stapler system, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

For the performance tests listed:

• Staple line pull-apart strength test: Actual measured mechanical strength.
• Staple formation test: Visual and/or microscopic assessment against defined criteria for properly formed staples.
• Staple line burst strength test: Pressure required to cause a leak in a stapled tissue sample.
• Hemostasis (free bleed time) evaluation: Time to cessation of bleeding after stapling in in-vivo models.
• Air leak test: Presence or absence of air leakage.
• Tissue trauma evaluation: Histopathological assessment of tissue damage in in-vivo models.
• Knife Cutting Performance test: Assessment of cut quality, completeness, and effort.
• Product security on Tissue test while clamping and firing: Observational and/or force-based assessment of device stability and tissue retention.
• Autoclave Reliability test: Functional performance after sterilization cycles.
• Egress of material test: Gravimetric or qualitative assessment of material release.
• Fire and clamp Shaft peak stall output torque measurement: Mechanical force measurements.
• Battery and Battery charger tests: Electrical and functional performance of power components.

The "ground truth" for these tests would be the objective physical or biological measurements and observations against pre-defined engineering and biological specifications.

8. Sample Size for the Training Set

Not Applicable / Information Not Available in Document: This question refers to machine learning algorithms. The iDrive™ System is a mechanical device, not an AI system that requires a "training set" in the machine learning context. All tests described are performance and safety evaluations, not data used for model training.

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

Not Applicable / Information Not Available in Document: As explained in point 8, there is no "training set" for this type of device.

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The iDR is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/ screen systems in all general - purpose diagnostic radiographic procedures. It is not intended for mammography applications.

Not Found

This document is a 510(k) clearance letter from the FDA for the iDR device, an x-ray system. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily:

• Acknowledges the submission and the substantial equivalence to a predicate device.
• Outlines regulatory requirements for the device.
• Specifies the "Indications for Use" for the iDR, which is "generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic radiographic procedures." It also explicitly states, "It is not intended for mammography applications."

Therefore, I cannot provide the requested information based on the provided text.

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The illifies/20tives/20tiveF, when used with compatible Linear Digital Loading Units®, has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The annives/iDrivell/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The illifies/40riveF/ infore, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end- to-side, and side-to-side anastomoses.

The iDrive is a reusable, hand-held medical device that is used to operate various SuraASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

The provided text is a 510(k) Summary for a medical device called iDrive. It describes the device, its intended use, and its similarities to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods based on the provided input. This information is simply not present in the given text.

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The iDriveS/iDrive&/iDriveF, when used with compatible Vascular Digital Loading Units®, have applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, fransection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

The iDrive is a reusable, hand-held medical device that is used to operate various SurgASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

This PMA pertains to a powered surgical stapler (iDrive) with various attachments (DLUs). The device itself is an incremental modification of a previously cleared device. Therefore, a comprehensive standalone performance study (such as a diagnostic accuracy or clinical trial), specifically for the AI component, is not relevant in this context. The provided text does not include information about acceptance criteria or a study proving that the device meets those criteria, as it's not a diagnostic AI device.

Here's an analysis of why these aspects are absent and what information is available in relation to your questions:

• No AI Component: The device described (iDrive) is a battery-powered surgical stapler handle designed to operate various Digital Loading Units (DLUs). There is no mention of any artificial intelligence, machine learning, or software algorithm for analysis, diagnosis, or prediction in the provided documentation. Therefore, questions related to AI performance, ground truth, experts, and reader studies are not applicable.
• Device Modification, Not Novel Device: The submission is a "Special 510(k) Device Modification." This means the iDrive is a modification of previously cleared predicate devices (i45, i45S, i60, i60S, Power Extenders). The core function and indications for use remain largely the same, with the modification primarily enabling the firing of multiple DLUs from a battery-powered, untethered hand-held device.
• Focus on Substantial Equivalence: For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically involves comparing technological characteristics and indications for use, often supported by bench testing and sometimes limited biocompatibility or sterility data, rather than large-scale clinical performance studies as would be required for a novel, high-risk device or a diagnostic AI.

Therefore, many of the specific questions you asked are not applicable to this type of device and submission.

Here's what can be extracted from the provided text based on your request, with an explanation of why certain information is missing:

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

• Not Applicable / Not Provided: This document does not contain acceptance criteria or performance data in the context of diagnostic accuracy or clinical outcomes, as it is a device modification for a surgical stapler handle, not a diagnostic AI device. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the performance is considered equivalent to the already cleared predicates.

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

• Not Applicable / Not Provided: As there is no described performance study for a diagnostic algorithm, there are no test sets, data provenance, or sample sizes related to AI performance. Device modifications for surgical staplers typically undergo bench testing for functional equivalence and safety, but the details of such testing (e.g., number of staples fired, force measurements) are not typically included in the summary provided for a Special 510(k) but would be in the full submission.

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: There is no AI component requiring ground truth establishment by experts.

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

• Not Applicable / Not Provided: No AI test set, therefore no adjudication method.

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 / Not Provided: There is no AI component, so no MRMC study involving human readers and AI assistance.

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

• Not Applicable / Not Provided: No AI algorithm.

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

• Not Applicable / Not Provided: No AI component requiring ground truth. For a mechanical device like this, "ground truth" would relate to engineering specifications and performance metrics verified by testing, not clinical diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: No AI component, therefore no training set.

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

• Not Applicable / Not Provided: No AI component, therefore no training set or ground truth for it.

In summary, the provided FDA 510(k) summary for the iDrive surgical stapler handle is for a device modification and does not involve any artificial intelligence or sophisticated diagnostic algorithms. Therefore, the questions related to AI performance, ground truth, experts, and reader studies are not addressed in this document.

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