(90 days)
For harvesting bone marrow.
The MarrowMiner is a device intended for harvesting bone marrow. The StemCor MarrowMiner bone marrow collection system is comprised of four components; a MarrowMiner battery powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide. The tip of the flexible aspiration shaft rotates and aspirates bone marrow. The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity.
The provided document is a 510(k) Premarket Notification summary for the StemCor Systems, Inc. MarrowMiner. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, study data, or performance metrics.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone performance (algorithm only) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on regulatory approval based on substantial equivalence to predicate devices, not on detailed performance study results against specific acceptance criteria. It mentions "The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity," but no specific data, acceptance criteria, or study details are provided.
§ 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.