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The Misonix Inc. neXus® Utrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in combination with SonaStar® probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kits

Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology

External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts

Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.

· Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

· Wound Care

Indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits

Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits

Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care

The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery

Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

The neXus® Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console. The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation unit provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site. Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.

The document provided is a 510(k) Pre-Market Notification from the FDA regarding the Misonix Inc. neXus® Ultrasonic Surgical Aspirator System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy from new clinical studies. Therefore, much of the information typically found in a study proving a device meets acceptance criteria for an AI/ML product (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) will not be present.

Instead, the acceptance criteria here relate to demonstrating that the neXus Ultrasonic Surgical Aspirator System is as safe and effective as its predicate devices. The "study" referenced in the document is a series of performance tests and compliance checks against various standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, "acceptance criteria" are generally compliance with recognized standards and a demonstration that the device's technological characteristics are comparable to the predicate devices and that the device performs as intended. The "reported device performance" are the results of various internal and external tests that affirm this.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The document describes engineering and regulatory compliance testing rather than a clinical study with a patient test set in the context of an AI/ML algorithm. The "test set" here would refer to the specific device units and components undergoing the various bench, electrical, and biocompatibility tests.
• Data Provenance: Not applicable. The data is generated from internal testing and validation processes conducted by the manufacturer (Misonix Inc.) to demonstrate compliance with standards and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device is its performance against engineering specifications and its compliance with regulatory standards, which is assessed through laboratory testing and comparisons to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, especially when establishing ground truth from multiple expert readings. This document reports on device performance and safety testing.

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

• Not applicable. This is a traditional medical device (ultrasonic surgical aspirator) without an AI component described in the submission. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or would be relevant.

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

• Not applicable. As noted, this device is an ultrasonic surgical aspirator, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this submission is based on engineering specifications, regulatory standards compliance, and direct comparisons to the established performance and characteristics of predicate devices. For biocompatibility, the ground truth is defined by the parameters and pass/fail criteria of the ISO 10993 standards. For electrical safety, it's the limits set by IEC 60601 standards. For functional performance, it is meeting the specifications equivalent to or better than the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As this device does not involve an AI/ML component or a training set, this question is not relevant.

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The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.

This document describes the Misonix SonicOne Plus Ultrasonic Wound Care System and Accessories, which is an ultrasonic surgical system used for wound debridement. The submission aims to demonstrate substantial equivalence to predicate devices, namely the SonicOne Ultrasonic Wound Care System (K112782) and the AUSS-7 Ultrasonic Surgical System (K070313).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of voluntary standards and successful completion of non-clinical tests. The "reported device performance" is essentially the statement that the device has "passed" these standards and tests. There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy provided, as this is a medical device for physical intervention, not diagnostic imaging or AI.

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

The document explicitly states: "As such, no additional clinical data was obtained in anticipation of this submission." This indicates that there was no dedicated test set involving human subjects or clinical data for this specific 510(k) submission. The safety and performance assessment relies on non-clinical tests, engineering validations, and substantial equivalence to previously cleared predicate devices.

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

Not applicable. There was no clinical test set requiring ground truth establishment by experts for this submission. The device's safety and effectiveness are established through engineering and biological testing against established standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

Not applicable. This device is an ultrasonic surgical system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI" is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by engineering standards and biological safety standards (e.g., ISO, IEC, UL, FCC for electrical safety, biocompatibility, sterilization, and electromagnetic compatibility). For the software component, the ground truth is its compliance with FDA guidelines and ISO 60601-1-4, as validated by previous clearance (K070313).

8. The Sample Size for the Training Set

Not applicable. The device is not an AI algorithm that requires a training set in the typical sense. Its design and operational parameters are based on established engineering principles and its predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set for an AI algorithm was used.

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