(19 days)
No
The device description focuses on the optical and mechanical components of a traditional arthroscope and explicitly states that it is identical to predicate devices except for an expanded intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended to "examine and / or perform surgery on the interior of a joint," indicating its use in both diagnostic and therapeutic procedures.
Yes
The device is described as being intended to "examine and / or perform surgery on the interior of a joint," indicating it can be used for both diagnostic (examination) and therapeutic purposes.
No
The device is a physical, tubular endoscopic device with lenses, fibers, and potentially a CCD, designed for surgical procedures. It is clearly hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HSW Arthroscope is a surgical instrument used to directly visualize and perform procedures inside a joint. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for "examine and / or perform surgery on the interior of a joint." This is an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) diagnostic test.
The device description and intended use clearly indicate it is a surgical endoscope for direct visualization and intervention within the body, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The HSW Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and / or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release).
Product codes
HRZ
Device Description
The Henke Sass Wolf of America's Arthroscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf of America's current Arthroscope and the Smith & Nephew Arthroscope. The only difference from the current Henke Sass Wolf of America's Arthroscope is the new intended use for hip surgery. This indication for use is already in place for the Smith & Nephew Arthroscope.
The arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. A series of rod lenses relay the image along the length of the tube. At the proximal end, in the case of a direct view model, an ocular lens forms an image for viewing directly with the human eye. In the case of a videoarthroscope, a proximal coupling lens relays the image to a CCD (charged couple device used as an electronic video sensor chip).
Arthroscopes generally come in two diameters, 2.7mm and 4.0mm, although other sizes are sometimes offered. Larger size arthroscopes are used for general viewing. This is due to the preferable larger and brighter image achievable with larger diameter optical components. The small sizes are used where access to the surgical site is restricted.
Arthroscopes generally come in several "directions of view", 0°, 30°, 70°, 90° and 110°, though others are sometimes offered. The center axis of the field of view of the 0° scope is along the normal axis of the Arthroscope. The other "direction of view" instruments are referenced from the scope normal axis. The various "directions of view" permit or facilitate viewing of different parts of the relevant anatomy.
All arthroscopes also contain glass fibers for illumination of the surgical site.
Henke Sass Wolf Arthroscopes are provided in Autoclavable and Non-Autoclavable models.
The imaging systems incorporated consist of:
- An objective lens which performs the image acquisition.
- A series of rod lenses relay the image from the distal end to the proximal end of the Arthroscope.
- A final optical element at the proximal end of the Arthroscope. In the case of a direct view model, an ocular lens forms and image for viewing directly with the human eye. In the case of a videoarthroscope, a proximal coupling lens relays the image to a CCD (charged couple device used as an electronic video sensor chip).
Illumination of the surgical site is provided by fiber optics internal to the Arthroscope. A mechanical coupling located at the proximal end of the device provides a method of connecting flexible light guides to external lightsources.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release)
Indicated Patient Age Range
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Intended User / Care Setting
surgeons / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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MAR 1 8 2008