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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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