(88 days)
Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
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The provided text, K013040 for the MINRAD, INC. Light Saber™ Introducer Needle, is a 510(k) summary and FDA clearance letter. It does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving a device meets those criteria, particularly for a device that relies on complex performance metrics like an AI/ML algorithm.
The Light Saber™ Introducer Needle is a physical medical device designed to gain percutaneous access for surgical procedures, and specifically to be used with a Dual Radiation Targeting System (DRTS) to improve needle placement accuracy.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this 510(k) submission for this type of device. The FDA clearance for this device, as indicated in the provided documents, is based on substantial equivalence to predicate devices, not on a clinical study demonstrating performance against specific numerical acceptance criteria for an AI/ML algorithm.
However, I can still extract relevant information about the device and its clearance process:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds. For substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to predicate devices.
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) akin to those for AI/ML algorithms are reported. The document states:
- "The Light Saber Introducer Needle is identical to a combination of its predicate devices."
- "These minor differences raise no new issues of safety or effectiveness."
- "Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not describe a clinical test set of real-world cases with associated data for an AI/ML algorithm. The equivalence is based on design comparison and intended use, not statistical performance on a dataset.
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. Ground truth establishment by experts for a test set is not part of a substantial equivalence submission for a physical introducer needle.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process as described for AI/ML algorithms is mentioned.
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. No MRMC study was conducted or reported for this device. The device itself is an introducer needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical introducer needle; there is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this submission. The "ground truth" for substantial equivalence is the existing regulatory classification and safety/effectiveness profile of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no AI/ML algorithm involved, so no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment process as described for AI/ML algorithms is mentioned.
In summary: The provided 510(k) summary for the MINRAD, INC. Light Saber™ Introducer Needle focuses on demonstrating substantial equivalence to existing predicate devices based on design, intended use, and technological characteristics. It does not involve performance studies or data analysis in the way modern AI/ML medical devices require, as it is a physical surgical tool.
§ 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.