(65 days)
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
The SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a cutter/stapler component addition to a Eodaing cleared device, K003277, SurgASSIST™ System with Circular Stapler Disposable Loading Unit. This Notification offers an additional style of cutting/stapling configuration, specifically, a right angle linear cutter/stapler of 45mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Right Angle Linear Cutter is utilizing the identical technology and system approach which the previously cleared device currently utilizes.
The technological features of the SurgASSIST™ System with Right Angle 45mm Linear Cutter are identical to that of the predicate device, K003277.
A steerable FlexShaft that serves as the interface between the . Digital Loading Unit™ (DLU) and the Power Console and provides the means of insertion of the DLU. The FlexShaft is steerable for surgical positioning of the DLU for access and visualization.
A hand held Remote Control Unit that contains pushbuttons . that actuate steering, extension and retraction of the anvil, stapling, and cutting.
Right Angle Linear Cutter Digital Loading Unit (DLU) that . contains implantable staples that form in a double staggered linear row of staples and a steel knife blade which transects the tissue between the two rows of formed staples. The Cutter is designed to between the center line of the FlexShaft, permitting access to tissue which may not normally be accessed via current stapling tissue whilen may re. The Right Angle Linear Cutter DLU is offered currently in a 45mm length size, in non-reloadable configuration.
This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55)) based on preclinical study in porcine subjects. | Deemed "substantially equivalent" for intended use based on a preclinical study in porcine subjects and additional laboratory bench testing. The specific performance metrics assessed and their achievement of equivalence are not detailed in the provided text, but the FDA's final letter confirms substantial equivalence. |
| Substantial equivalence to predicate device (Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55)) based on additional Laboratory Bench Testing. | Deemed "substantially equivalent" for intended use based on a preclinical study in porcine subjects and additional laboratory bench testing. The specific performance metrics assessed and their achievement of equivalence are not detailed in the provided text, but the FDA's final letter confirms substantial equivalence. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "preclinical study in porcine subjects," but the exact number of subjects or procedures (sample size) is not specified.
- Data Provenance: Prospective (as it's a preclinical study specifically designed for this purpose). The location is not explicitly stated but is implied to be within a controlled laboratory or animal study setting, likely in the US where the submitter is located.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical devices like linear cutters, ground truth is typically assessed through objective measurements of stapling integrity, transection completeness, and tissue healing, rather than expert consensus on subjective interpretations. The preclinical study would likely involve veterinary surgeons or researchers specializing in animal models.
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Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations, which is not relevant for this type of device and study. Performance would be assessed by objective criteria.
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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 a surgical stapler, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical stapler.
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The type of ground truth used:
- For the preclinical study: Ground truth would be based on objective evaluations of the stapling performance in live tissue (porcine subjects), likely including:
- Staple formation and integrity.
- Hemostasis at the staple line.
- Tissue transection completeness.
- Healing characteristics over time.
- Comparison against the predicate device's performance in the same parameters.
- For the laboratory bench testing: Ground truth would be based on objective physical measurements and tests of the device's mechanical properties, staple formation, and cutting ability.
- For the preclinical study: Ground truth would be based on objective evaluations of the stapling performance in live tissue (porcine subjects), likely including:
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The sample size for the training set: Not applicable. This is a medical device (linear stapler), not an AI/ML algorithm that requires a training set. The device design and manufacturing processes are developed through traditional engineering methods.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML sense for this 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.