Search Results

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

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.

Ask a specific question about this device

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

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).

Ask a specific question about this device

Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Reprocessed Arthroscopic Burs are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a Bur or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the Bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur on blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site

The provided document K012652 is a 510(k) summary for "Reprocessed Arthroscopic Burs" and does not describe an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance typical for AI/ML devices, such as those involving sensitivity, specificity, or human expert performance.

Specifically, the document focuses on demonstrating substantial equivalence of reprocessed medical devices to predicate devices. The performance data mentioned relates to:

• Biocompatibility
• Validation of reprocessing
• Function Test(s)

The conclusion states that performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended, implying that they meet the same performance standards as new, unreprocessed devices, which are the predicate devices.

Since this is not an AI/ML device submission, the requested information elements such as a table of acceptance criteria vs. reported AI performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and are not present in the provided text.

Ask a specific question about this device