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The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.

The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.

The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy).

The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.

The provided 510(k) summary for the UroMed® Needle Grasper does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars. The document focuses on demonstrating substantial equivalence to predicate devices based on design and material standards, rather than presenting a performance study with specific acceptance criteria that would typically be found in direct performance assessment.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission relies on "Summary of Standards Achieved" for materials and biocompatibility to establish equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a performance test set or clinical study to assess device performance in the way implied by this question.

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)

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is described.

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

Not applicable. This device is a manual surgical instrument and does not involve AI or human "readers" in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth for performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of predicate devices and adherence to material standards.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or a performance study.

9. How the ground truth for the training set was established

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of available information regarding compliance/study:

The 510(k) submission for the UroMed® Needle Grasper primarily demonstrates substantial equivalence through adherence to recognized standards and comparison to legally marketed predicate devices.

• Study Type: This is not a performance study with "acceptance criteria" in the sense of effectiveness or diagnostic accuracy. It's a regulatory submission demonstrating substantial equivalence primarily through design comparison and material compliance evaluations.
• Compliance to Standards: The device's "performance" is implicitly demonstrated through its construction from materials that meet established standards for surgical instruments and biocompatibility:
  • ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.
  • USP Class VI Biocompatibility.
• Equivalence to Predicate Devices: The core of the justification is that the UroMed Needle Grasper is "substantially equivalent to legally marketed devices" (Cook Endoscopic Grasping Forceps, Laurus Medical Suture Placement System) in terms of its intended use, indications for use, and basic function. The text states: "Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness."

In conclusion, the 510(k) summary provided does not contain the information requested for a detailed performance study with specific acceptance criteria and ground truth establishment, as it focuses on demonstrating substantial equivalence through design, materials, and intended use alignment with existing predicate devices and adherence to specific material standards.

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