(19 days)
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).
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.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Henke Sass Wolf Arthroscope.
Important Note: The provided document is a 510(k) submission for a medical device (Arthroscope). In this context, "acceptance criteria" and "studies" are typically focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance benchmarks through extensive clinical trials. The criteria and studies revolve around proving that the new device is as safe and effective as its predicates. Therefore, some of the requested information (like specific performance metrics measured in a clinical study, effect sizes of human readers with AI, etc.) is generally not present in this type of submission.
Description of Acceptance Criteria and Supporting Study for Henke Sass Wolf Arthroscope
The Henke Sass Wolf Arthroscope's acceptance criteria and supporting "study" are primarily based on demonstrating substantial equivalence to predicate devices, namely the Henke Sass Wolf of America Laparoscope (K962075) and the Smith & Nephew, Inc. Arthroscope (K971253). The submission argues that the device's design, materials, manufacturing, optical performance, and safety are identical or highly similar, with the only significant change being an expanded intended use to include hip surgery, which is already an indicated use for one of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Submission) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Intended Use | Must align with or expand upon predicate devices in a substantially equivalent manner. | Expanded to include hip surgery; aligns with Smith & Nephew Arthroscope (K971253) for this indication. |
| Design | Must be identical or highly similar to predicate devices. | "Identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW Arthroscopes." |
| Materials | Must be medical grade and identical to predicate devices. | "Identical to the Henke Sass Wolf of America Arthroscope - K962075 and the Smith & Nephew, Inc., Arthroscope - K971253. All materials used are medical grade." (Includes specific details of stainless steel, titanium, P.E.E.K., glass, sapphire, solder, adhesive.) |
| Physical Properties | Must be identical to predicate devices. | "Identical to the Henke Sass Wolf of America Arthroscope - K962075 and the Smith & Nephew, Arthroscope - K971253." |
| Optical Performance | Must be identical to predicate devices. | "Identical... in terms of optical performance." (Specifications for diameter, direction of view, field of view, eyepiece magnification, working length are provided, consistent with arthroscope standards.) |
| Safety | Must exhibit equivalent safety profile to predicate devices. | "Identical... in terms of... safety." (Biological evaluation, electrical safety, sterilization validation cited as evidence.) |
| Sterilization | Must be capable of effective cleaning and sterilization according to recognized standards. | Non-sterile, reusable. Validated for cleanability and repeat sterilization (Sterrad 100S, Steam Sterilization). Sterilization validation conducted for predicate devices deemed applicable. Achieves SAL of 10-6. |
| Manufacturing | Must follow similar methods of construction as predicate devices. | Mentions "modes of construction" are identical. Notes that Smith & Nephew Arthroscopes are manufactured by Henke Sass Wolf, GmbH, implying consistent manufacturing processes. |
2. Sample Size Used for the Test Set and Data Provenance
- No specific "test set" in the conventional sense of a prospective clinical study with patient data is mentioned for device performance. The primary "testing" for substantial equivalence relies on comparing the device's specifications and characteristics to those of predicate devices already on the market.
- Data Provenance: The data provenance is based on the existing design, materials, and validated manufacturing processes of the manufacturer's own existing arthroscope line and the Smith & Nephew arthroscope (which is also manufactured by Henke Sass Wolf, GmbH). This is retrospective in the sense that it refers to established device characteristics and prior validation reports rather than a new prospective data collection specifically for this submission's comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. As this is a 510(k) submission for substantial equivalence based on design and material comparisons, rather than a clinical study evaluating diagnostic accuracy or treatment outcomes, there is no mention of external experts or a ground truth panel in the context of a test set. The "ground truth" implicitly lies with the established performance and safety of the predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. No test set requiring expert adjudication is described in the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance, which is outside the scope of this arthroscope submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is an arthroscope, a physical medical instrument for direct visualization and surgical procedures, not an algorithm or software-controlled device. "Standalone" performance as described for AI algorithms is not relevant here. The submission explicitly states, "Device incorporates software? No."
7. The Type of Ground Truth Used
- The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics (design, materials, optical performance, manufacturing methods) are compared against these known predicates to demonstrate that it is equally safe and effective for its expanded intended use.
- For the sterilization validation, the ground truth is established by AAMI/ISO Standards (e.g., SAL of 10-6), with a "worst case scenario" device (a 0° 10mm Operative Laparoscope) being used to validate the Sterrad 100S system.
8. The Sample Size for the Training Set
- Not Applicable. As it's a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The design and validation are based on engineering principles and regulatory standards rather than data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
§ 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.