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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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