(80 days)
The PORTAGE System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the PORTAGE Endoscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the PORTAGE System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
The PORTAGE System is comprised of an endoscope and manual athroscopic instruments.
The PORTAGE Endoscope is a reusable rigid endoscope, comprised of a fiber optic cable and sensitive image transmission system with eyepiece. The PORTAGE Endoscope is used for visualization of the surgical field during arthroscopic or spinal procedures and may be used in conjunction with a separately cleared and commercially available light quide, light source, video camera, monitor and printer. Light that is created by the external light source is transmitted from the PORTAGE Endoscope light quide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system. The subject endoscope is manufactured in a 90° short confiquration and is used with a compatible bracket. The PORTAGE Endoscope is supplied non-sterile.
The PORTAGE System accessories are manual instruments that include retractors, dilators, rongeurs, forceps, suture passers, cutters, pushers, probes, curettes and gouges. They enable the physician to perform any type of surgical spinal procedure. The manual instruments are either single-use and supplied sterile, or reusable and supplied non-sterile.
The reusable PORTAGE System components have undergone complete reprocessing validations, including manual cleaning and steam sterilization.
This document is a 510(k) Summary for the PORTAGE™ System, an arthroscope, seeking FDA clearance. It describes the device's substantial equivalence to a predicate device (METRx System, K002931) rather than presenting a performance study against specific acceptance criteria for an AI/ML powered device.
Therefore, the provided text does NOT contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria for an AI/ML system.
The "Performance Testing" section states: "Performance testing has been completed for the PORTAGE System to demonstrate substantial equivalence to the predicate METRx System (K002931). As applicable, the system components have been subjected to the following verification and validation testing: general performance including endoscope field and direction of view, diopters, eccentricity, size of view, and vignetting, biocompatibility, system compatibility and usability. All test requirements were met as specified by applicable standards and the test protocols."
This indicates that general device performance (optical properties, usability, biocompatibility) was tested to show it functions similarly to the predicate, it is not an AI/ML powered device, thus there is no AI/ML related performance to discuss.
Based on the provided text, I cannot answer the questions about acceptance criteria and a study for an AI/ML device. The document describes a traditional medical device (an arthroscope) and its 510(k) clearance process, which focuses on substantial equivalence to a predicate device, not on AI/ML performance metrics.
§ 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.