(21 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Device cuts and staples identically to predicate devices | "The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809)." |
| Enhanced ease of use (swiveling anvil functionality) | "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." |
| Maintained Indications For Use | "The Power Right Angle Linear Cutter Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Right Angle Linear Cutter Digital Loading Units® (K012089 and K021701)." |
| Maintained safety and effectiveness as predicate devices | Implied by the substantial equivalence determination for a modification not impacting core performance. |
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.
§ 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.