(24 days)
The line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscopic procedures. Endoscopic examination and treatment of the nasal cavities and nasal pharynx.
In addition, the Smith & Nephew 4 mm diameter rigid Arthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in: The removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Smith & Nephew Arthroscopes are reusable devices and are sterilized using a variety of sterilization methods. Arthroscopes are used by being inserted into an artificial opening of the human body to provide illumination and visualization of a joint space. The optical design of the standard arthroscope consists of the objective lens which creates the image and transfers it through the optical train by means of identical relays that maintain the image quality with very little degradation.
Here's an analysis of the provided text regarding the Smith & Nephew Arthroscope (K072675). Unfortunately, the document does not contain the detailed performance data, acceptance criteria, or study design information requested in many of your points. The provided text is a 510(k) summary, which is typically a high-level overview.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. The document states "All verification data demonstrates that the device is safe and effective and performs as intended," but it does not specify what those acceptance criteria were or present the numerical results of any performance tests.
2. Sample size used for the test set and data provenance
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided in the given text.
4. Adjudication method for the test set
This information is not provided in the given text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
This information is not provided in the given text. Given the nature of an arthroscope, it's highly unlikely that an MRMC study comparing human readers' performance with and without an "AI" component would be relevant or conducted for this type of device. Arthroscopes are visualization tools, not AI diagnostic algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is an arthroscope, a tool for direct visualization, not an algorithm.
7. The type of ground truth used
This information is not provided in the given text. For an arthroscope, ground truth might relate to image quality metrics, field of view, or light intensity, but these specifics are not mentioned.
8. The sample size for the training set
This information is not applicable/not provided. As the device is a physical arthroscope and not an AI algorithm, there would not be a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary of Study Information (Based on Available Text):
The provided K072675 document is a 510(k) Pre-market Notification for a medical device (Smith & Nephew Arthroscope). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present extensive clinical study data (unless specifically required for the type of device and its risk profile).
- Study Description: The document refers to "verification data" that "demonstrates that the device is safe and effective and performs as intended." However, it does not describe any specific "study" in detail, nor does it lay out acceptance criteria or performance metrics.
- Purpose of the "Study": To show that the new Smith & Nephew Arthroscope is substantially equivalent to existing Smith & Nephew Arthroscopes (K043395) and meets its intended use of providing illumination and visualization for diagnostic and operative arthroscopic procedures and ENT examinations.
- Evidence presented: The document states that the device has "the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and are manufactured under a Quality System." This implies that the 'study' or verification likely involved engineering tests, functional checks, and comparisons against the predicate device's established performance parameters.
In essence, the provided document is a regulatory submission for substantial equivalence rather than a detailed scientific study report with specific acceptance criteria and performance data. For a physical device like an arthroscope, "performance" would typically refer to optical quality, illumination, durability, sterilization efficacy, and mechanical integrity rather than diagnostic accuracy of an AI algorithm.
§ 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.