(21 days)
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
| Information Type | Detail |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not available. The document does not describe specific quantitative or qualitative acceptance criteria for the device's performance, nor does it report on any specific performance metrics from a study against such criteria. The focus is on demonstrating that the modified device functions identically to the predicate devices. |
| 2. Sample size and data provenance (test set) | Not available. There is no mention of a specific test set or any associated data provenance (country of origin, retrospective/prospective). The document primarily discusses the device's design and its intended use, along with a comparison to predicate devices, but not a performance study. |
| 3. Number/qualifications of experts (ground truth for test set) | Not available. Since no specific test set or performance evaluation against a ground truth is described, there is no mention of experts establishing ground truth or their qualifications. |
| 4. Adjudication method (test set) | Not available. Without a described test set or performance evaluation, there is no adjudication method detailed. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | Not available. The document describes a "device modification" to the iDrive where components become detachable from the handpiece, and states that the device "functions identically" to its predicates. It does not mention any MRMC study, human-in-the-loop performance, or AI assistance. The device appears to be a mechanical surgical stapler system, not an AI-assisted diagnostic or prognostic tool. |
| 6. Standalone (algorithm only) performance study | Not applicable/Not available. This device is a mechanical surgical instrument, not an algorithm. Therefore, a standalone algorithm-only performance study would not be relevant, and none is described. |
| 7. Type of ground truth used | Not available. No ground truth for performance evaluation is described, as the document focuses on substantial equivalence for a modified device rather than de novo performance testing. |
| 8. Sample size for training set | Not applicable/Not available. As the device is a mechanical surgical instrument and not an AI/algorithmic system, there would be no "training set" in the context of machine learning. The document describes a modification to an existing device, and the evaluation relies on comparison to predicate devices. |
| 9. How ground truth for training set was established | Not applicable/Not available. See point 8. |
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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.