(89 days)
The HBL Blade Assembly is indicated for use with the 3M Agee Inside Job Carpal Tunnel Release System or MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:
- Carpal tunnel release in the wrist
- Cubital tunnel in the elbow
The HBL Blade Assembly is a surgical device designed to divide the ligament during an endoscopic carpal tunnel release (ECTR) or the fascia during an endoscopic cubital tunnel release (ECuTR). This device is capable of elevating a cutting blade from a retracted position within the cannula to an exposed position for cutting the ligament or fascia. Once the ligament or fascia has been divided, the cutting blade can be returned to a safe position within the cannula.
The HBL Blade Assembly is composed of a probe assembly that is fabricated using medical grade injection molded plastic, and both a spring and cutting blade that are fabricated using stainless steel. The Blade Assembly is provided sterile and designed for single use.
The provided text is a 510(k) summary for the HBL Blade Assembly. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria using an AI/ML context.
The document discusses performance data related to mechanical aspects and a cadaveric study, which are typical for mechanical medical devices, not AI/ML-driven devices. There is no mention of algorithms, machine learning, AI models, or human-in-the-loop studies in the context of diagnostic accuracy improvement.
Therefore, I cannot provide the requested information from the given text as it relates to an AI/ML device. The device described, the HBL Blade Assembly, is a surgical tool, and its performance evaluation involves physical and mechanical properties, as well as surgical use in a cadaveric setting, not the kind of AI/ML performance metrics you've asked about.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.