(88 days)
The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.
The device a manually adjusted retractor system. It has a single- piece retractor/access port, fiber optic light cable accessory, 2 sets of 4 varying-sized dilators and assorted manual surgical instruments whose handles conform to the shape of the retractor/access port.
This document is a 510(k) premarket notification for a medical device called the "Micro-Access Spine System" (MASS). The FDA's letter states that the device is substantially equivalent to previously marketed devices and permits it to be marketed.
However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria.
The document primarily focuses on:
- Device Identification: Product name, classification, common name, trade name.
- Submitter Information: Company details.
- Predicate Devices: Listing of similar devices to which the MASS is compared for substantial equivalence.
- Description of the Device: Briefly describes components (retractor/access port, fiber optic light cable, dilators, surgical instruments).
- Intended Use: For spinal surgery consistent with the working dimensions of the retractor/access port.
- Comparison to Predicate Products: States that predicate devices have the same intended use, principle of operation, general design, and materials. It also mentions that "Differences between the new and predicate devices were subjected to bench, cleaning and sterilization testing to demonstrate that they do not affect safety and effectiveness."
There is no detailed information on:
- Specific acceptance criteria for performance, safety, or effectiveness.
- The design or results of any studies (bench, clinical, or otherwise) that measure the device's performance against quantifiable criteria.
- Sample sizes for tests, data provenance, expert involvement for ground truth, or adjudication methods for studies.
- Any multi-reader multi-case (MRMC) or standalone algorithm performance studies (as this is a manual surgical instrument, not an AI/software device).
- How ground truth was established for any hypothetical training set.
Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and study details because that information is not present in the provided text. The document confirms that bench, cleaning, and sterilization testing were performed on differences between the new and predicate devices to demonstrate they do not affect safety and effectiveness, but it doesn't elaborate on the criteria or results of these tests.
§ 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.