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The Misonix Inc. neXus® Ultrasonic 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, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kit
Indicated for use in the fragmentation, emulsification 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, fibromas, 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 resection such as segmentectomical subsegmentectomies and metastatectomies. · 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 and aspiration 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

neXus SonaStar Handpieces with SonaStar Probe Kits
Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:
· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access 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 adentis, 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 resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite 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 - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
• · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The system 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 system 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, disposable electrocautery cable, and waste collection canisters.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) K231117 clearance letter for the "neXus Ultrasonic Surgical Aspirator System." This type of document is a summary of the FDA's decision and the manufacturer's provided information. It does not present a detailed study report that would typically include all the specific parameters requested (like sample size for test/training sets, experts, adjudication methods, MRMC studies, effect sizes, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K221235). The "performance data" section primarily refers to verification and validation activities rather than a comparative clinical trial or large-scale evaluation of a new AI algorithm.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Information Not Provided in this Document," as this submission is for a modified traditional medical device, not an AI/ML-driven diagnostic or treatment planning system that would typically undergo the stringent evaluation methods you've outlined.

Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the modified neXus Ultrasonic Surgical Aspirator System is substantially equivalent to its predicate device (K221235). The "acceptance criteria" here are implicitly tied to maintaining the safety and effectiveness profile of the predicate device, particularly regarding the added "Pulsed Wave, NEW" feature for the vibration system and "DTC (DYNAMIC TISSUE RESPONSE)" capability.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) summary, the acceptance criteria are not presented in a quantitative table with specific targets as one might see for an AI/diagnostic device. Instead, they are framed as demonstrating continued functionality, safety, and equivalence to the predicate. The "reported device performance" is largely qualitative, indicating that the new features function as intended and that the overall system still meets the established performance of the predicate.

Key Difference/New Feature: Vibration System: "Pulsed Wave, NEW" (p. 10).
New GUI Setting: "DTC (DYNAMIC TISSUE RESPONSE): Off" (default) and adjustable range 1-6 (p. 16). |
| Biocompatibility | No new patient-contacting materials; existing biocompatibility data remains valid. | "Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid." (p. 17) |
| Electrical Safety & EMC | Continued compliance with relevant safety and EMC standards; minor software update does not impact electrical safety or EMC. | "No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid." (p. 18) |
| Software V&V | Software performs as intended, new features function correctly, regression testing confirms no adverse impact elsewhere. Software classification remains "major level of concern." | "Software verification and validation testing was conducted and a summary of testing provided."

Specific verification tests conducted: "DTC DSP pulse mode verification," "DTC GUI verification," "Fault detection and response test using the SonaStar Elite handpiece," "neXus test and calibration (Regression testing)," "System performance verification (Regression testing)," "SonaStar Elite GUI verification (Regression testing)." (p. 18) |
| Bench Testing | New features function as intended and device maintains performance characteristics (e.g., tissue removal) of the predicate. | "Tissue removal test using the SonaStar Elite handpiece," "DTC mode vibration test using the SonaStar Elite handpiece." (p. 18) |

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

• Sample Size: Not explicitly stated in terms of number of "cases" or "samples" as might be seen for a diagnostic AI. For a surgical aspirator, "test set" typically refers to the physical devices and materials (e.g., tissue phantoms, actual tissue samples for bench testing) used for verification and validation. The document does not specify the quantity of these for bench testing.
• Data Provenance: Not applicable in the conventional sense of patient data. The "data" here comes from internal engineering and quality testing (software V&V, electrical safety, biological compatibility assessments, and bench performance testing). These are typically conducted in a controlled lab environment by the manufacturer. No country of origin for a patient dataset. The tests are prospective as they are conducted specifically for this submission.

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

• Number of Experts/Qualifications: Not applicable for this type of device submission. Ground truth for a surgical tool's performance is established through engineering specifications, physical measurements, and performance against defined test methods (e.g., how effectively it removes tissue from a phantom, its vibration amplitude). Clinical "experts" (like radiologists) are not used to establish this type of ground truth.

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

• Adjudication Method: Not applicable. This concept applies to human consensus on complex subjective data (e.g., image interpretation). For an ultrasonic surgical aspirator, performance testing involves objective measurements (e.g., output power, vibration frequency, tissue removal efficiency, software function).

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:

• MRMC Study: No. This is not an AI-driven diagnostic or image-interpretation device, so MRMC studies are not relevant. This device is a surgical tool.
• Effect Size of Human Improvement with AI: Not applicable for this device.

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

• Standalone Performance: Not applicable as this is not an AI algorithm but a physical medical device. The "software" component is for controlling the device's functions (e.g., vibration, irrigation, aspiration). The software's performance is verified through testing its functionalities and its impact on the device's physical outputs, but not as a "standalone" interpretation tool.

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

• Type of Ground Truth: For this device, ground truth is established through:
  • Engineering specifications and design requirements: The device's components and software features are designed to meet specific physical and functional performance parameters.
  • Validated test methods: Performance is measured against established procedures using instruments and materials (e.g., tissue phantoms) to quantify characteristics like vibration, flow rates, and tissue ablation effectiveness.
  • Comparison to predicate device: The predicate device itself acts as a "ground truth" for acceptable performance for the intended use.
  • Compliance with recognized standards: Adherence to standards like IEC62304 for software and electrical safety standards.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a "training set" of data for model development. The software is deterministic control software, subject to traditional software development and verification processes.

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

• Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML.

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