(60 days)
The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:
· Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.
In addition, Smith+Nephew 4 mm diameter rigid athroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
The proposed Smith+Nephew 4KO Direct View/Video Arthroscopes are a line extension to the previously cleared K971253 and are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals.
The Arthroscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The Arthroscopes are shipped non-sterile and must be cleaned, inspected and sterilized prior to each use. Both designs consist of a long tube containing a series of rod lenses that work to transfer the image of the patient's anatomy, through an associated visualization camera system, to a central monitor for clinical use in treatment.
The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith+Nephew C-Mount camera head.
Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.
This inquiry pertains to a 510(k) premarket notification for the "Smith+Nephew Arthroscopes" (K201349). The provided documentation describes a medical device, specifically an arthroscope, which is a type of endoscope used for visualization during diagnostic and operative arthroscopic procedures.
The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria in the manner one would typically expect for an AI/ML product. The document instead focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical arthroscope.
Therefore, many of the requested fields cannot be filled as they are explicitly related to AI/ML device testing and evaluation.
Here's a breakdown of the available information and why other fields cannot be completed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Optical Performance | Met performance specifications |
| Leakage Integrity | Met performance specifications |
| Electrical Safety Testing | Met performance specifications |
| Electromagnetic Compatibility | Met performance specifications |
| Cleaning Validation | Met all acceptance criteria per AAMI TIR 12:2010 and AAMI TIR 30:2011 |
| Sterilization Validation | Met all acceptance criteria per AAMI TIR 12:2010 and AAMI TIR 30:2011 |
| Biocompatibility | Met all acceptance criteria per ISO 10993-1:2018 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance Testing" in general terms for the physical device but does not specify sample sizes for these tests, nor the origin or nature of the data (e.g., patient data, in-vitro testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a physical arthroscope, not an AI/ML diagnostic or image analysis tool requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
5. 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
This information is not applicable as this is not an AI/ML device, and no MRMC study is detailed for its comparison or human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the reasons stated above. The "ground truth" for a physical arthroscope's performance would relate to physical specifications and functional tests, not clinical diagnostic ground truth.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or associated ground truth establishment process.
§ 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.