(165 days)
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® 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 adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or maligmant, 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
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 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.
Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kit
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 reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
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 acceptance criteria and supporting study details for the Misonix Inc. neXus Ultrasonic Surgical Aspirator System (K212060) are described below based on the provided text.
Based on the provided document, the device described is an ultrasonic surgical aspirator system, and the filing is a 510(k) premarket notification for substantial equivalence. This type of filing generally focuses on comparing a new device to an existing predicate device rather than presenting novel clinical efficacy studies with specific acceptance criteria directly comparable to new AI/diagnostic technologies. Therefore, the information provided does not directly align with a typical acceptance criteria table and study design for AI-based diagnostic devices.
However, I can extract the relevant performance data and study types conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for a 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The performance data presented are primarily to show that the technological characteristics and performance are substantially equivalent.
| Acceptance Criteria (Demonstrated Equivalence to Predicate K190160) | Reported Device Performance (Misonix neXus Ultrasonic Surgical Aspirator System K212060) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards for biological safety. | Passed: Testing included Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Cytotoxicity (ISO 10993-11), and Pyrogenicity (USP ). |
| Sterilization & Shelf Life: Single-use components are sterile; reusable components can be sterilized. Maintain sterile barrier and efficacy for a defined shelf life. | Single-use components (Probe Kits) are provided sterile: Sterilization method unchanged from predicate. Reusable components (handpiece parts) are end-user cleaned and sterilized: Validated instructions for use provided, including expected use life. Shelf Life: Accelerated testing demonstrated acceptable 37-month shelf life. Real-time aging studies for 13 months were provided, with 37-month real-time studies planned. |
| Electrical Safety & EMC: Comply with relevant IEC 60601 standards. | Passed: Complied with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, and IEC 60601-1-2:2014. No significant differences related to compliance with these standards between the subject and predicate devices. IEC 60601-2-2:2017 was not applicable to the subject device (but was for the predicate with electrosurgery). |
| Software Verification & Validation: Software functions as intended and does not pose undue risk. | Passed: Software verification and validation (V&V) testing was conducted, and documentation was provided as recommended by FDA guidance for "major" level of concern software. |
| Bench Testing: Demonstrate functional equivalence to the predicate in key performance areas. | Passed: Tests performed included: Ultrasound Performance Testing, Acoustic Intensity Testing, Applied Part Temperature Testing (Normal and Abnormal Operating Conditions), Hard Tissue Performance Testing, and Thermal Testing of Simulated Bone Tissue on BoneScalpel Access Handpiece and Tips. The document states these tests "support the claim of substantial equivalence," implying the results were comparable or within acceptable ranges relative to the predicate. |
Study Details:
The provided document describes studies conducted to support a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device (K190160). This is not equivalent to a performance study for an AI diagnostic device.
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document primarily discusses bench testing, biocompatibility testing, electrical safety, EMC, and software V&V. These are engineering and laboratory tests, not clinical studies in the context of diagnostic device performance.
- No "test set" of patient data (images, clinical records) is mentioned.
- The provenance of materials for bench/biocompatibility testing (e.g., simulated bone, biological samples) is not specified.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI diagnostic algorithm requiring expert "ground truth" for a test set of patient data. The studies involve laboratory measurements and engineering assessments.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication of a test set is described.
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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 MRMC study was conducted. This device is an ultrasonic surgical aspirator, a therapeutic surgical tool, not a diagnostic AI system assisting human readers.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware surgical device, not an algorithm. Performance tests evaluate the device's physical outputs and safety parameters.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is defined by the biological response of cells/tissue to the device materials, evaluated against established ISO standards.
- For electrical safety/EMC: Ground truth is defined by compliance with published international safety standards (e.g., IEC 60601 series).
- For software V&V: Ground truth is defined by the software specifications and requirements.
- For bench testing: Ground truth is defined by engineering specifications, physical measurements, and comparison to the predicate device's known performance characteristics.
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8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
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9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this device.
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