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The iDrive Intelligent Power Unit with iConsole, when used with:

a) compatible Intelligent Surgical Instrument Linear Staplers , have 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.

b) compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

c) compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

d) compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has 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, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.

The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments in order to resect tissue, transect tissue and create anastomoses between structures. The iDrive was previously cleared to market via K073001 and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intelligent Surgical Instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the iDrive Intelligent Power Unit with iConsole:

Unfortunately, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification summary, which focuses on establishing substantial equivalence to predicate devices rather than reporting on performance studies against defined criteria.

Here's a breakdown of what is and is not available in the given input, organized according to your requested points:

Acceptance Criteria and Study for iDrive Intelligent Power Unit with iConsole

Summary of the Provided Document:

The provided document is a 510(k) premarket notification for the iDrive Intelligent Power Unit with iConsole. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K073001, K073148, K071708).

The "study" in this context is the comparison made to the predicate devices. The document states:

• "The iDrive with iConsole, when used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments, functions identically to the predicate devices..." (Page 2, Section 5 - Device Modification)
• "The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments and functions identically to the predicate devices. The electronics, power configuration, and internal gearing & transmission are common to both predicate and subject devices. Both the predicate and subject devices are powered mechanically by rotational energy. In both the predicate and the subject device, a clamp shaft drives a clamp screw, which causes the anvil to close and compress tissue. The same is true for firing." (Page 3, Section 7 - Comparison to Predicate Devices)

This means the "proof" that the device meets acceptance criteria (implied to be "performs as safely and effectively as the predicate devices") is based on a technical comparison and functional assessment showing that the modifications (making the instruments detachable) do not change the fundamental operation, electronics, power configuration, or tissue manipulation mechanism that were validated in the predicate devices. This is a common approach for 510(k) submissions for device modifications.

No new clinical or performance studies with specific acceptance criteria, test sets, or ground truth establishment are detailed in this 510(k) summary.

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The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdomihal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.

The provided FDA 510(k) summary (K083527) is for a medical stapling device, the "Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads." This submission details modifications to an existing predicate device (K071708) and asserts substantial equivalence based on identical technological features except for a pivot point translation.

Based on the provided document, the typical detailed acceptance criteria and study data for a device with an AI component are not present. This is because the device described is a mechanical stapling device, not an AI/software-as-a-medical-device (SaMD) or AI-augmented device in the modern sense. The term "Intelligent" in its name likely refers to its design or features at the time of its 2008 submission, rather than AI capabilities for diagnosis, prediction, or data analysis.

Therefore, many of the requested points related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as they are typically associated with devices that use algorithms for analytical or interpretive functions.

However, I can still extract the information relevant to a traditional medical device submission, focusing on the device's functional equivalence and indications for use.

Acceptance Criteria and Device Performance (for a Mechanical Device)

For a device like this, the "acceptance criteria" and "performance" would typically revolve around mechanical tests, bench testing, and potentially animal or cadaver studies to demonstrate:

• Tissue compression force
• Staple formation consistency and strength
• Cutting performance
• Leakage rates (if relevant to the application)
• Durability and fatigue testing of components
• Biocompatibility of materials

The provided 510(k) summary does not contain specific numerical acceptance criteria or detailed study results for these types of mechanical performance, as is common in a 510(k) summary which focuses on demonstrating substantial equivalence rather than providing full study reports. The summary notes that the modified device has "identical technological features as the predicate device" (K071708) and "functions the same as the predicate device."

Table of Acceptance Criteria and Reported Device Performance (Conceptual, as details are not provided in the document):

Information (Not Applicable or Not Provided for an AI Device)

2. Sample size used for the test set and the data provenance: Not applicable/provided. This device is mechanical; performance is typically demonstrated through bench testing or animal studies, not a "test set" of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., expert radiological reads, pathology reports) is not relevant for this mechanical stapler.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For a mechanical device, "ground truth" might refer to physical measurements of staple line integrity or tissue compression, demonstrated through standard engineering tests.

8. The sample size for the training set: Not applicable. There is no AI model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Intelligent Articulating and Straight Endoscopic Linear Cutters -- Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

The Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are reusable, articulating and non-articulating, handheld vascular surgical staplers. The devices are supplied non-sterile and must be cleaned and sterilized prior to use. The device creates a linear transection with three staggered rows of titanium staples on each side of the cutting blade.

The provided text is a 510(k) summary for a medical device (surgical stapler) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic AI device submission would. The document focuses on demonstrating substantial equivalence to predicate devices, not on performance metrics of an AI algorithm.

Therefore, I cannot extract the requested information based on the provided text. The document describes a physical surgical stapler with a modified staple pocket design and updated software to operate it. It is not an AI/ML-based diagnostic device.

If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the relevant information.

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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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The i45, i45s, i60, i60s have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The devices described here are reusable i45, i45S, i60, i60S used in conjunction with a variety of Reloads, which were previously cleared to market under K052415. The i45, i45S, i60, i60S are designed to be cleaned and sterilized for multi-patient use.

The i45, i45S, i60, i60S is an integrated stapler that articulates left and right. In addition to motors for stapling and cutting, and articulation, the proximal housing holds the battery and electronics enabling untethered use. Device control is managed with buttons and rocker switches on the proximal housing. The device will be steam sterilized. All product patient contact materials adhere to industry standards.

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (linear staplers), which focuses on demonstrating substantial equivalence to predicate devices rather than the performance of a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation will not be applicable or explicitly stated in this type of document. The device in question is a physical medical instrument, not an AI system.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document describes a linear stapler with implantable staples (i45, i45S, i60, i60S). The 510(k) submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not the performance of an AI algorithm based on acceptance criteria in the typical sense of AI/ML evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device and a 510(k) summary, specific "acceptance criteria" and "reported device performance" in the context of an AI algorithm (e.g., sensitivity, specificity, AUC) are not directly applicable or stated for this product. The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to predicate devices in terms of:

• Intended Use: Identical.
• Technological Characteristics: Similar, with justified differences.
• Safety and Effectiveness: No new questions of safety or effectiveness are raised.

The document states:

• "The i45, i45S, i60, i60S have identical technological features as the predicate devices (K003277, K021249, and K040720)."
• "The Indications For Use statement is identical to that which appears in the CMLC predicate device (K040720)."
• "All product patient contact materials adhere to industry standards."
• The device is designed to be cleaned and sterilized for multi-patient use, and is steam sterilizable.

Therefore, the "performance" is implicitly deemed equivalent to the predicate devices which have already been cleared for market.

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

Not applicable. This device is a physical stapler, not an AI algorithm evaluated on a data test set. Information regarding a "test set" or "data provenance" (country of origin, retrospective/prospective) is not found in the document.

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

Not applicable. This is not an AI algorithm requiring expert consensus for ground truth on a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool where human readers' performance with/without AI assistance would be evaluated.

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

Not applicable. This is a physical medical device.

7. Type of Ground Truth Used

Not applicable. The "ground truth" for this device's clearance is its substantial equivalence to existing, legally marketed predicate devices, meaning its intended function and safety profile are considered comparable to those previously cleared.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

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

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The Power Extenders have 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 Power Extenders are components of the SuraASSIST® System. A hand-held medical instrument, which connects the FlexShaft and Digital Loading Units® (DLUs) providing rigid capability, longitudinal positioning and mechanical interface of the DLU during surgical procedures. Power Extenders serve as a conduit between the DLUs and the Power Console. They obtain the mechanical and electrical power from the PC100 via the FlexShaft. Internally, the instrument contains drive-shafts that couple with the driveshafts in the FlexShaft. Rotary motion provided by the motors (located in the PC100) is delivered to the instrument through these drive shafts for various purposes such as clamping tissue or forming staples with attached DLUs.

The provided document is a 510(k) summary for the Power Extenders device, which are components of a surgical stapler system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting the results of a standalone study with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and expert involvement are not applicable or provided in this type of regulatory submission. This document is a regulatory filing for a Class II medical device (surgical stapler component), not a research study report.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/provided in this document.
The 510(k) submission states that "The Power Extenders used with the predicate Power Linear Cutter Reusable Digital Loading Unit®, cuts and staples identically to the predicate device (K052415)." This implies that the performance criteria are met by virtue of being functionally identical to an already cleared device. Performance data, if any, would be part of a separate technical report submitted to the FDA and not typically included in the public 510(k) summary in this level of detail.

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

Not applicable/provided.
This document does not describe a separate experimental "test set" in the context of typical AI/software performance studies. The core of this 510(k) is a comparison to a predicate device.

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

Not applicable/provided.
Ground truth establishment is not relevant for this type of device and regulatory pathway. The device's function (cutting and stapling) is mechanical, and its equivalence is demonstrated through comparative analysis with a predicate device, likely involving engineering testing and design comparisons, not expert-adjudicated datasets.

4. Adjudication Method for the Test Set

Not applicable/provided.
Adjudication methods are typically relevant for complex interpretative tasks, often in image analysis or diagnostic AI. This device is a surgical instrument component.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No, a MRMC study was NOT done.
This type of study is specifically for evaluating the impact of AI on human interpretation or decision-making. The Power Extenders are mechanical components of a surgical stapler and do not involve human "readers" or AI assistance in this context.

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

Not applicable.
This device does not contain an "algorithm" in the sense of AI or software for interpretation that would have standalone performance. Its function is mechanical.

7. The Type of Ground Truth Used

Not applicable/provided.
As this is a mechanical surgical device and not an interpretive AI system, the concept of "ground truth" (e.g., pathology, outcomes data) as it pertains to diagnostic or prognostic accuracy is not relevant here. The "truth" in this context would relate to engineering specifications, material properties, and functional performance matching the predicate device.

8. The Sample Size for the Training Set

Not applicable/provided.
This document describes a medical device, not an AI or machine learning model that would require a "training set."

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

Not applicable/provided.
As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant in this context.

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The Natural Orifice Linear Cutter Digital Loading Units® with Reloads have 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 device described here is a Natural Orifice Linear Cutter Digital Loading Unit ® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transections and the creation of anastomoses.

I am sorry, but the provided text from K063075 does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (Natural Orifice Linear Cutter Digital Loading Units®), focusing on its substantial equivalence to a predicate device. It describes:

• Submitter information
• Device name and classification
• Predicate device
• Device description
• Device modification (changes from the predicate device)
• Indications for Use
• Comparison to predicate devices

It explicitly states that the modifications are related to the handle, shaft, and anvil material, and that the device "cuts and staples identically to the predicate device." It also notes that the indications for use are identical to the predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document. This typically falls under validation testing, which is often referenced in a 510(k) but the detailed results and criteria are not usually included in the summary itself.

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The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.

This document describes a Special 510(k) Pre-Market Notification for a device called "Power Circular Stapler Digital Loading Units®". This is a surgical stapling device, and the submission is for a modification to an existing, cleared device (SurgASSIST® Circular Stapler Digital Loading Units®, K003277).

Due to the nature of this submission being a Special 510(k) for a surgical stapler device modification, the provided text does not contain information related to software-driven acceptance criteria or the type of study typically conducted for AI/ML-driven medical devices. The description focuses on mechanical device modifications and their functional equivalence to the predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device studies (sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) because this information is not present in the provided text. The device is a mechanical surgical stapler, not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted and why the other information is absent:

1. Table of acceptance criteria and the reported device performance:

Explanation for Inferred Criteria and Performance:
The document states, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device, Circular Stapler Digital Loading Units® (K003277)." It also confirms, "The Power Circular Stapler Digital Loading Units® have the same indications for use and the same functionality as the previously cleared predicate Circular Stapler Digital Loading Units® (K003277)." In a Special 510(k) for a device modification, the primary "acceptance criterion" is typically demonstrating substantial equivalence in performance and safety to the predicate device, especially when the core mechanism and indications remain unchanged.

Missing Information (and why it's missing for this type of device):

• 2. Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. Testing for a mechanical device modification would typically involve bench testing, animal studies, or cadaver studies, but the specifics are not detailed in this high-level summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-assisted diagnostic device.
• 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.): Not applicable. The "ground truth" for a surgical stapler is its mechanical performance (e.g., staple formation, tissue approximation, leak testing) and clinical outcome (e.g., successful anastomosis), but these details are not provided in the summary.
• 8. The sample size for the training set: Not applicable. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained.

Summary of the Study for Substantial Equivalence:

The study proving the device meets the acceptance criteria (i.e., substantial equivalence) is implicitly a comparison study against its predicate device (K003277). The modifications made (reduced rigid length, relocated gearing, redesigned anvil clamping mechanism) are presented as not altering the fundamental stapling mechanism or the indications for use.

The statement, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device," serves as the primary evidence presented in this summary for meeting the performance criteria. The "Predicate Comparison Chart in Section J" (not provided in this excerpt) would have contained the detailed technical comparison data. Such a comparison would typically involve engineering analysis, bench testing, and potentially some form of in-vitro or ex-vivo testing to demonstrate equivalent staple formation, strength, and sealing characteristics. However, these specific study details are not expanded upon in the provided K061649 summary.

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The Power Right Angle Linear Cutter Digital Loading Units® have applications in gastrointestinal, gynecological, and general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The device described here is a Power Right Angle Linear Cutter Digital Loading Unit® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses. The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809). The Power Right Angle Linear Cutter Digital Loading Unit® was modified to enhance ease of use. This new design enables the anvil to swivel 90 degrees once the DLU is opened beyond 16 mm, allowing the user to work in confined anatomical areas.

This document describes a Special 510(k) Device Modification for the Power Right Angle Linear Cutter Digital Loading Unit®. The modification enhances ease of use by enabling the anvil to swivel 90 degrees once opened beyond 16mm, allowing for work in confined anatomical areas. The device's indications for use and functions remain the same as its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a Special 510(k) summary for a device modification. For this type of submission, extensive new clinical studies with defined acceptance criteria are often not required if the modification does not change the fundamental operating principle, safety, or effectiveness, and substantial equivalence can be demonstrated through non-clinical testing.

The document states: "The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809)." This is the primary performance claim, implying that the modified device's core function (cutting and stapling) meets the same performance as the already cleared predicate devices.

The acceptance criteria for a "Special 510(k)" typically involve demonstrating that the design modification does not adversely affect the safety and effectiveness of the device as previously cleared. This is often done through engineering analysis, verification, and validation testing (e.g., mechanical testing, materials testing, functional testing) to show that the modified device still performs within specified parameters and meets the same safety and performance requirements as the predicate device.

No specific quantitative acceptance criteria or reported device performance metrics (e.g., staple height, cutting force, anastomotic integrity) are explicitly detailed in this summary. The implicit acceptance criterion is that the modified device performs identically to the predicate devices in its primary function of cutting and stapling. The modification is primarily focused on usability ("ease of use") by allowing the anvil to swivel, which is a design change to enhance maneuverability without altering the fundamental stapling mechanism.

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

The document does not explicitly mention sample sizes for specific test sets or the provenance of data for any testing done. For a Special 510(k) focusing on a design modification for usability, non-clinical bench testing or engineering analysis is typically used instead of clinical trials. Such testing would involve a sufficient number of samples to ensure statistical validity for mechanical and functional performance, but these details are not provided in this summary.

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)

This information is not provided in the document. As this is a medical device for surgical procedures, "ground truth" as typically defined in diagnostic AI/imaging studies (e.g., expert consensus on image interpretation) is not directly applicable. Performance is usually assessed via engineering specifications and functional testing.

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

This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective endpoints, which are not detailed here.

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

An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for this device.

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

This point is not applicable. The device is a mechanical surgical stapler, not an AI algorithm. Its performance is inherent in its design and operation, not through an algorithm.

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

For this type of device modification, "ground truth" would be established through objective engineering specifications and functional testing. For instance, the ability for the anvil to swivel 90 degrees beyond 16mm would be verified through direct measurement. The identical cutting and stapling performance would be verified through bench testing (e.g., staple formation, tissue compression, cut line integrity) against established engineering specifications matched to the predicate device. The document does not detail the specific ground truth types for these tests.

8. The sample size for the training set

This information is not applicable. The device is a mechanical surgical instrument, not an AI model requiring a training set.

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

This information is not applicable, as there is no training set for a mechanical surgical device.

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