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The MiNS grasping instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate other soft internal tissues as well as items such as hernia mesh.

Device Description

The MiNS devices are a family of disposable and re-useable devices. Consisting of an integrated, insulated needle/cannula shaft that houses a retractable grasper (NLU) which are inserted into a reusable Handle. The disposable NLU's when inserted into a reusable Handles are used for mobilization and manipulation of soft tissue during general laparoscopic procedures. The system has the ability to directly penetrate soft tissue to access certain areas of the human anatomy without the need for a traditional insertion conduit. The shaft of the instrument can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate, grasp and manipulate soft tissue.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the MiNS Needlescopic Resposable Laparoscopic device system, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that "The subject device has been subjected to and passed a variety of bench tests for mechanical and attribute evaluations." However, it does not explicitly list specific quantitative acceptance criteria or corresponding reported performance metrics in a table format for the MiNS device itself. Instead, it relies on substantial equivalence to predicate devices, implying that its performance is acceptable if it is comparable to the predicates without introducing new risks.

The comparison table provided focuses on technological characteristics rather than specific performance metrics for the new device versus a benchmark.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (MiNS Needlescopic Resposable Laparoscopic device system)
Use	Comparable to predicate devices; ability to penetrate soft tissue, grasp, hold, and manipulate soft internal tissues and hernia mesh.	"The MiNS grasping instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh." (Matches predicate K070686)
Needle Diameter	2.4mm ± .1mm (based on predicate K070686) or generally comparable to needlescopic instruments.	2.4mm ± .1mm
Device Length	300 mm (based on predicate K070686)	300 mm
Material Composition	Medical Grade Stainless Steel (17-7 SS, 300 SS, 475SS, Polyester) (comparable to predicates)	Medical Grade Stainless Steel 17-7 SS, 300 SS, 475SS, Polyester
Sterilization	Autoclavable for reusable handle, sterile disposable for shaft tip combinations. (comparable to predicate K113407)	Autoclavable, non sterile, reusable handles with attachable disposable sterile, single use shaft tip combinations. (Differs from K070686 which is sterile, single use, but aligns with the mixed approach of reusable handle + disposable tip, similar to K113407)
Safety & Efficacy	No new risks to the patient compared to predicate devices.	"Mini Lap MiNS Needlescopic Resposable device system does not present any new risks to the patient and therefore, we believe that it is substantially equivalent to other devices and technologies cleared by the FDA."

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states the device "has been subjected to and passed a variety of bench tests for mechanical and attribute evaluations." However, it does not specify the sample size for these bench tests, nor does it mention data provenance (country of origin, retrospective/prospective).
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 the evaluations conducted were "bench tests for mechanical and attribute evaluations," rather than clinical studies requiring expert ground truth for interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided, as the conducted tests are bench tests, not clinical evaluations requiring adjudication of results from independent reviewers.
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:
No MRMC comparative effectiveness study was done. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device does not include software or an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the mechanical and attribute bench tests, the "ground truth" would be engineering specifications and established test methods to verify physical properties, material compatibility, and functionality. It is not expert consensus, pathology, or outcomes data.
The sample size for the training set:
Not applicable. This device does not have a training set, as it is a manual surgical instrument without software or machine learning components.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.

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