(313 days)
The Prosurg's Neo-Arthroscope ™ -Digital Video Arthroscopic System (which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.
The Single Use Digital Video Arthroscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end or in the sidewall, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the distal end of the Arthroscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The Single Use Neo- Arthroscope is designed to be completely isolated from irrigation and suction fluid pathways. The design of sealed distal end and proximal end of the outer sheath / cannula also prevents any fluid or tissue contact with Neo-Arthroscope.
The Neo-Arthroscope ™ - Digital Video Arthroscopic System consists of four main components:
- (a) Digital Video Arthroscope with CMOS Sensor & Built-in LEDs / Fiber optic. (Patient Contact Item)
- (b) Single Use, Outer Sheath / Cannula with Suction / Irrigation, a separate, dedicated channel for insertion of video Arthroscope and /or Trocar for insertion. (Patient Contact Item)
- (c ) Laptop /Tablet computer with windows Operating System, TV monitor module and Video processing Software. (Commercially Available, Non patient Contact Item)
- (d) USB 2.0 / HD Connecting Cables. (Commercially Available, Non Patient Contact Item)
The provided document focuses on the 510(k) premarket notification for the "Neo-Arthroscope™ - Single Use Digital Video Arthroscopic System." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a statistical performance against acceptance criteria in the context of a diagnostic AI algorithm.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This document describes a medical device (an arthroscope) and its physical and functional characteristics, not software or AI performance.
The document describes "Performance Testing (Bench Testing)" but these tests are for the physical device's safety and effectiveness, not for a diagnostic algorithm's accuracy.
Here's what can be extracted regarding the device's validation from the provided text:
Performance Testing (Bench Testing) Categories:
The manufacturer, Prosurg, conducted performance testing (Bench Test Evaluation) as per FDA Guidance Document to demonstrate the safety and effectiveness of the Neo-Arthroscope™ device for its intended use. The following tests were completed:
- Dimensional Measurements (Outer Diameter, Working Length)
- Field of View (in air)
- Image Resolution (Number of Pixels)
- Direction of View
- LED Brightness, Voltage & Current measurement.
- USB / HD Connection compatibility with Laptop / Tablet / Monitor
- Electrical Safety Test (IEC 601-1)
- Electromagnetic Compatibility (IEC 601-1-2)
- Thermal (Heat) Temperature at the Distal Tip (LED)
- Product Labeling & IFU Requirements & Accuracy
- Packaging Integrity & Sterility Assurance Test
- Accelerated Aging Test (one Year)
- Sterilization Assurance Level (ISO 11135-1:2007)
- ETO Residual Levels (ISO 10993-7:2008)
- Biocompatibility (ISO 10993-1:2009)
Conclusion from the document:
"The results of the performance testing demonstrate that proposed Neo- Arthroscope Single Use Digital Video Arthroscopy system performs as well as predicate device and is considered safe and effective for its intended use."
Regarding your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The performance tests listed are general safety and engineering specifications, not statistical performance metrics for decision-making.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device clearance, not an AI algorithm. The "test set" here refers to physical performance tests of the arthroscope itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.