(24 days)
The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device. The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
The provided text describes a medical device, the Laurimed Percutaneous Discectomy System, and its regulatory clearance process through a 510(k) submission. However, it does not include the information requested regarding acceptance criteria, a study proving device performance against those criteria, or details about ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, along with a summary of non-clinical testing.
Here's a breakdown of why I cannot fulfill your request with the given input:
- Acceptance Criteria and Reported Device Performance: The document states, "Results of non-clinical testing demonstrated that the Laurimed Percutaneous Discectomy System is safe and effective for its intended use." and "non-clinical testing was conducted to validate the performance of the device and ensure the Laurimed Percutaneous Discectomy System functions as intended and meets design specifications." However, it does not provide a table of specific acceptance criteria or the reported performance data for those criteria.
- Sample size for test set and data provenance: No information is provided regarding a "test set" in the context of an algorithm or AI. This device is a physical surgical tool.
- Number of experts and qualifications for ground truth: Not applicable, as there is no mention of algorithms, AI, or ground truth established by experts for a test set.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI system being compared to human readers.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable. The "ground truth" for a physical device would typically be its functional performance in accordance with design specifications and its safety profile. In this case, it's assessed through non-clinical testing.
- Sample size for the training set: Not applicable, as there is no mention of a "training set" for an algorithm or AI.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/algorithm-based device. Therefore, the information requested, which is highly relevant to AI/ML device evaluations, is not present in this text.
§ 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.