(114 days)
The Needlecatcher is designed for grasping suture needles during suturing and holding them during transport throughout the operating theatre.
The Needle Catcher ™ is a stainless steel needle grasping instrument for use in suturing tissue to allow both tissue retaining and needle grasping in the same instrument. The Needle Catcher ™ uses a piston and cylinder assembly to grasp and hold the needle safely during knot tying.
The provided document, K051281, is a 510(k) premarket notification for the "Needlecatcher™" device. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results that would typically be found in a comprehensive clinical or performance study report.
Instead, the document states: "Using the instrument on artificial skin and animal tissue with a variety of surgeons, nurse operators and medical students its indicated that it is safe and easy to use and that it achieves its indicated functions of needle grasping and needle shielding." This statement summarizes the findings of a performance evaluation but lacks the structured detail required to populate the requested table and provide specific answers to many of the questions.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's the information that can be inferred or directly stated from the document, along with explanations for what cannot be provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Indicated that it is safe and easy to use. |
| Ease of Use | Indicated that it is safe and easy to use. |
| Functionality (Needle Grasping) | Achieves its indicated function of needle grasping. |
| Functionality (Needle Shielding) | Achieves its indicated function of needle shielding. |
| Other criteria from the document | None explicitly stated or quantifiable. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "a variety of surgeons, nurse operators and medical students" and "artificial skin and animal tissue" but does not quantify the number of participants or the amount of tissue used.
- Data Provenance: The study appears to be a performance evaluation conducted as part of the 510(k) submission process. It involved "artificial skin and animal tissue," implying laboratory or simulated settings, not human clinical trials. The location of this testing is not specified, though the applicant is based in Northern Ireland. It is retrospective in the sense that the results are being reported as part of a submission, but the tests themselves would have been prospective for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified. The document states "a variety of surgeons, nurse operators and medical students" were involved in "using the instrument," but it doesn't clarify if these individuals established a ground truth, or were simply users providing feedback.
- Qualifications of Experts: The broad categories "surgeons," "nurse operators," and "medical students" are mentioned. No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not described. The document only reports that the instrument was "indicated" to be safe and effective, suggesting an overall consensus or observation, but no formal adjudication process (like 2+1 majority voting) is detailed.
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
- MRMC Study: No, this document describes a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improve with AI vs without AI assistance" is not relevant to this device and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The "Needlecatcher™" is a manual surgical instrument, not an algorithm. Its performance is inherently human-in-the-loop as it is operated by a healthcare professional.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" seems to have been based on observational feedback and assessment by users (surgeons, nurses, medical students) during the instrument's use on "artificial skin and animal tissue." This is a form of expert assessment of performance and ease of use, rather than a definitive "ground truth" established by pathology or strict outcomes data typically seen in diagnostic device studies.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a mechanical surgical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for a mechanical device.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.