(69 days)
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.
This document is a 510(k) summary for the BioAccess Marrow Harvest System, submitted in 1997. It describes a medical device and its substantial equivalence to previously marketed devices. The document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria, as it pertains to a physical medical device (a marrow harvest system) and not an AI/ML powered device.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically associated with AI/ML device submissions, which are much more recent than a 1997 510(k) for a physical surgical instrument.
§ 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.