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The FLOW 90 Wand, used with Qualified Controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:

All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)

• Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon)
• Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane,Tendon)

Hip

• Excision/Resection - (Acetabular Labrum)

Knee

• Ablation/ Debrideement - (ACL/PCL, Notchplasty)
• Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy)

Shoulder

• Ablation/ Debrideement - (Subacromial Decompression)
• Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)

Wrist

• Excision/Resection - (Triangular Fibrocartilage)

The FLOW 90 Wand is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)).

The FLOW 90 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified FLOW 90 Wand.

The provided text is a summary of a 510(k) premarket notification for a medical device called the FLOW 90° Wand. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The relevant section, "NON-CLINICAL Testing," mentions electrical safety and bench testing (flow rate, fluid ingress, suction tube kinking, finger switch testing, and packaging validation), but these are for a physical electrosurgical device, not an AI/ML system.

Therefore, I cannot provide the requested information as it is not present in the given document.

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The FLOW 90° Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:

The FLOW 90 Wand (Wand) is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Similar to the predicate device FLOW 50 Wand (K162074), FLOW 90 Wand is designed to be exclusively used with WEREWOLF® COBLATION® System (K162074). The FLOW 90 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the WEREWOLF Controller to support the use of the Flow 90 Wand.

This document describes a 510(k) premarket notification for the "FLOW 90º Wand", an electrosurgical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the "FLOW® 50 Wand" (K162074).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing as establishing that the device meets "established design criteria and supports substantial equivalence with the predicate device." However, specific numerical acceptance criteria (e.g., pass/fail thresholds for ablation rate, thermal effects) are not explicitly stated in a table format. Instead, the document mentions the types of tests performed and the general conclusion that the device "meets all design and performance specifications."

Reported Device Performance (Qualitative):

2. Sample Size Used for the Test Set and Data Provenance:

The document states:

• "Pre-clinical bench testing (ex vivo testing) was performed across multiple tissue models (muscle, tendon, cartilage and meniscus) to verify substantial equivalence to the predicate device in terms of thermal effects."

Sample Size: Not explicitly stated. The phrase "multiple tissue models" implies more than one instance of each tissue type but does not give a specific number.
Data Provenance: Ex vivo testing. This means the testing was performed on biological tissue outside of a living organism, typically in a laboratory setting. The country of origin for the data is not specified. It is retrospective in the sense that the device design was complete before these tests were conducted to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This device is an electrosurgical wand, and the performance testing described is hardware-based (e.g., ablation rate, thermal effects, electrical safety). There is no mention of human expert evaluation being used to establish ground truth for the device's functional performance in the way it might be for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As stated above, this is for hardware performance testing, not for subjective interpretation or diagnostic evaluation requiring adjudication between multiple human readers.

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:

No. The document explicitly states: "No clinical data are included in this submission." and "No animal data are included in this submission." This indicates that a human-in-the-loop study, such as an MRMC study, was not performed or included. This device is a surgical instrument, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Partially yes (for the device's functional performance). The performance testing described (software verification and validation, non-clinical, and preclinical bench testing) assesses the device's functional characteristics and safety without human-in-the-loop evaluation for diagnostic purposes. This is characteristic of standalone performance evaluation for a medical device. However, it's critical to note this is not an AI algorithm being evaluated in a standalone manner, but rather the electrosurgical wand itself.

7. The Type of Ground Truth Used:

The ground truth for the functional performance tests was established by objective measurements and comparisons to the predicate device. For example:

• Ablation testing: Likely involved measuring the amount or rate of tissue removal.
• Thermal effects: Involved measuring temperature changes in and around the tissue.
• Electrical safety: Compliance with electrical safety standards.
• Biocompatibility: Testing materials for biological compatibility.

The ground truth is based on objective physical and biological measurements in a controlled laboratory setting, not on expert consensus, pathology, or outcomes data in a clinical context.

8. The Sample Size for the Training Set:

Not applicable. This device is an electrosurgical wand with no mention of machine learning or AI algorithms requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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