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neXus Ultrasonic Surgical Aspirator System

Reference & Predicate Devices

K190160

Intended Use

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

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

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

· Thoracic Surgery

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

Device Description

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
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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K Number

K190160

Device Name

Manufacturer

Misonix, Inc.

Date Cleared

2019-05-30

(120 days)

Product Code

LFL,GEI

Regulation Number

N/A

Type

Panel

SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES

Reference & Predicate Devices

K070313,K062471

Intended Use

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

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

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

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Specific Criteria (from standards or comparison)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 series for patient and fluid path contacting components.	Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogenicity) was performed in accordance with ISO 10993-1, -5, -7, -10, -11, -12, and the results "demonstrate that the patient and fluid path contacting materials are biocompatible."
Sterilization & Shelf Life	Compliance with FDA guidance for sterile device submissions; demonstration of sterility and performance after sterilization and aging.	Submission included required sterilization information. Sterile barrier testing and device performance testing on sterilized and accelerated aged devices supported a shelf life of 3 months for single-use disposables. Validated instructions for cleaning and sterilization, and expected use life, are provided for reusable components.
Electrical Safety & EMC	Compliance with ANSI/AAMI/ES 60601-1, IEC 60601-2-2, and IEC 60601-1-2 standards.	Electrical safety and EMC testing were conducted. Test results "demonstrate that the neXus system meets the applicable requirements for this device type."
Software V&V	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a "major" level of concern software.	Software verification and validation testing were conducted. Documentation was provided, and test results "demonstrate that the neXus system has been fully verified and validated for its intended use." The software was considered "major" level of concern.
Bench Performance	Device meets all specifications and requirements met by predicate devices for ultrasound, irrigation, aspiration, RF compatibility, and wireless coexistence.	Performance testing "demonstrated that the device continues to meet all of the specifications and requirements that were met by the predicate devices" for: Ultrasound Performance, Irrigation Performance, Aspiration Performance, OEM RF Compatibility, and Wireless Coexistence Testing. Specifications for vibration system, irrigation pump flow rate, and vacuum pump flow rate are detailed and compared to predicates.
Substantial Equivalence	Indications for use and technological features are equivalent to predicate devices, and do not raise new questions of safety or effectiveness.	The indications for use are equivalent, and the technological comparisons (Table 1 and following text) show similar characteristics or improvements that do not raise new safety/effectiveness concerns.

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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K Number

K123980

Device Name

Manufacturer

Date Cleared

2013-03-05

(69 days)

Product Code

NRB,FQH

Regulation Number

878.4410

Type

Special

Panel

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES

Reference & Predicate Devices

K112782,K070313

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Voluntary Standards & Non-Clinical Tests)	Reported Device Performance
UL 60601-1 2nd Edition (Medical Electrical Equipment, Part 1: General Requirements for Safety)	Passed
IEC 60601-1* 2nd Edition (Medical Electrical Equipment, Part 1: General Requirements for Safety)	Passed
ISO 10993-1:2009 (Biological evaluation of medical devices —Part 1: Evaluation and testing)	Passed
ISO 10993-7:2008 (Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals)	Passed
ISO 14971:2007 (Medical devices -- Application of risk management to medical devices)	Passed
ISO 15223-1:2007/A1:2008 (Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements)	Passed
ISO 11607:2006 (Packaging for Terminally Sterilized Medical Devices)	Passed
ISO 11135:2007 (Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)	Passed
IEC 62304: 2006 (Medical Device Software-Software Life Cycle Processes)	Passed
IEC 60601-1-4 (General Requirements for safety-Programmable electrical medical systems)	Passed
FCC Part 18 (EMC Requirements)	Passed
Output Frequency Measurements	Performed
Output Power Measurements (No Load to Maximum Load)	Performed
Tip Displacement Measurements	Performed
Irrigation Flowrate Measurements	Performed
Life Tests	Performed
Input Power Measurements	Performed
EMI Tests	Performed
Dielectric Tests on Mains Circuits	Performed
Patient Current Leakage and Patient Sink Current Measurements	Performed
Power Line Ground Leakage Measurements	Performed
Dielectric Tests on Patient Circuits	Performed
Sterilization Validations (ANSI/AAMI/ISO 11135:1994 or latest and ISO 11135:2007)	Validated
Reprocessing (cleaning/disinfecting/sterilization) instructions validation	Validated
Software Validation (cleared under FDA 510k #K070313, meets FDA guideline "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and ISO 60601-1-4)	Cleared and Meets Requirements

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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K Number

K112782

Device Name

Manufacturer

Date Cleared

2011-12-01

(66 days)

Product Code

NRB,FQH

Regulation Number

878.4410

Type

Panel

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

Reference & Predicate Devices

K062544,K050776,K050322

Intended Use

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 judgement would require the use of an ultrasonic aspirator with sharp debridement.

Device Description

The SonicOne Ultrasonic Wound Care System 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 handpiece sheaths.

AI/ML Overview

The provided text describes the Misonix SonicOne Ultrasonic Wound Care System and Accessories, focusing on its substantial equivalence to predicate devices rather than independent clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested sections regarding acceptance criteria, study data, and ground truth establishment cannot be fully populated from the given information.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (if stated)	Reported Device Performance (if stated)
Safety Standards	Compliance with:	The device has been designed and tested to pass the following voluntary standards:

IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
IEC 60601-1-2:2001 (Medical Electrical Equipment General Requirements for EMC)
FCC Part 18 (EMC Requirements)
ISO 10993-1:2009 (Biological evaluation of medical devices —Part 1: Evaluation and testing)
ISO 10993-7:2008 (Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals)
ISO 15223-1:2007/A1:2008 (Medical devices —Symbols to be used with medical device labels, labeling, and information to be supplied —Part 1: General requirements) |
| Performance (Functional) | Not explicitly stated. | The SonicOne is stated to be "identical to the AUSS-6 Ultrasonic Surgical Aspirator cleared under 510K #K050776." It is also considered substantially equivalent in "Mode of Operation, Hardware Design and Output Parameters" to the predicate devices. This implies it meets the performance characteristics of those cleared devices. |
| Clinical Efficacy | Not explicitly stated. | "The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission." This refers to a determination of substantial equivalence based on predicate devices' clearance, not a new clinical study. |

Study Details (Based on Substantial Equivalence Claim)

Sample size used for the test set and the data provenance:
- No direct test set for performance on patients was used for this 510(k) submission. The submission relies on the substantial equivalence to predicate devices (Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System K062544 and Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776).
- Therefore, there is no specific data provenance (country of origin, retrospective/prospective) for a new clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical test set with ground truth established by experts was used for this submission. The basis for clearance is substantial equivalence to already cleared devices and their established indications for use.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical test set requiring adjudication was performed as part of this 510(k).
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 a physical medical device (ultrasonic wound care system), not an AI/software-based diagnostic or assistive tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not contain software and is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k), the "ground truth" for efficacy is implicitly the established safety and effectiveness of the predicate devices for their cleared indications. The submission argues that the SonicOne is substantially equivalent in design and function, therefore sharing the same safety and efficacy profile.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no training set in the context of AI.
How the ground truth for the training set was established:
- Not applicable. See above.

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K Number

K070779

Device Name

Manufacturer

Date Cleared

2008-07-09

(476 days)

Product Code

NTB

Regulation Number

878.4400

Type

Panel

K042096,K002615,K032333,K050347

Reference & Predicate Devices

Intended Use

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.

Device Description

The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 042096). The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600.

The Sonatherm 600i operates in the same manner as the Sonatherm 600. The Sonatherm 600i operates by utilizing a focused ultrasound transducer positioned at the surface of the targeted ablation area to create a thermal lesion from the focal point of the transducer back to the surface of the targeted area in an open field or laparoscopic scenario.

The Sonatherm 600i incorporates three changes to the Sonatherm 600: a microprocessor controlled LCD user interface; a visually aided focal point targeting system; an integrated transducer positioning device

The microprocessor controlled LCD user interface incorporates a graphical interface that makes the operation of the device easier. The integrated positioning device allows the user to verify the positioning of the Sonatherm 600i probe over the intended target volume. This reduces the chance for operator error.

AI/ML Overview

The Sonatherm 600i Ultrasonic Lesion Generating System, a modification of the previously cleared Sonatherm 600, was reviewed. This device generates thermal lesions for the laparoscopic or intraoperative ablation of soft tissue. The 510(k) summary provides details about its non-clinical testing.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or a specific table with "reported device performance" in the typical sense of a diagnostic device. However, it lists nonclinical tests performed to demonstrate substantial equivalence, which implicitly serve as the studies to meet underlying performance expectations for safety and effectiveness.

Acceptance Criteria Category (Implied)	Reported Device Performance/Study Conclusion
Targeting Accuracy	"Sonatherm 600i Targeting Accuracy Test Report": This report would demonstrate the device's ability to precisely direct the ultrasonic energy to the intended ablation area. While specific performance metrics (e.g., deviation from target in mm) are not provided in the summary, the existence of the report implies successful demonstration of adequate targeting for its intended use.
Thermal Lesion Generation	"Thermal Mapping of Ablation Region": This study would characterize the size, shape, and temperature distribution of the lesions created by the device. The goal is to confirm that the device generates consistent and effective thermal lesions within the soft tissue as intended, similar to the predicate device. Specific performance values are not given.
Imaging Operation Validation	"Validation of Imaging Operation": This test validates the functionality and accuracy of the visually aided focal point targeting system, ensuring it provides reliable guidance to the user. This would confirm that the integrated positioning device helps reduce operator error. Specific performance values are not given.
Acoustic Power Output	"Total Acoustic Power Tests of Transducers": This testing confirms that the transducer's power output is consistent with the predicate device (Sonatherm 600) and within safe and effective limits. The summary explicitly states: "The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600," implying successful verification of this.
Overall Safety and Efficacy	Conclusion from Nonclinical Tests: "Based upon an analysis of the operating characteristic specifications, Risk Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Sonatherm 600i is substantially equivalent to the predicate devices and introduces no new safety or efficacy concerns."

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

The provided 510(k) summary does not specify a "test set" in the context of human data or a machine learning model. The studies described are non-clinical engineering and performance tests (e.g., targeting accuracy, thermal mapping). Therefore, information on sample size for a "test set" or data provenance (country of origin, retrospective/prospective) for patient data is not applicable as no clinical studies were performed, and the non-clinical tests would involve physical measurements and simulations, not patient data.

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

This information is not applicable. Since the studies involved non-clinical performance evaluations of a medical device (e.g., measuring power output, thermal profiles), the "ground truth" was established by engineering specifications, physical measurements, and comparison to the predicate device's known performance. No human experts were involved in establishing "ground truth" for patient data in this context.

4. Adjudication Method for the Test Set

This information is not applicable. As there was no test set of patient data requiring expert review, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The 510(k) summary explicitly states: "No clinical testing is required because product did not change HIFU power output or type. Note: clinical data was also not required to clear the original device." Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned and clinical studies were not performed.

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

This information is not applicable. The Sonatherm 600i is a physical medical device (ultrasonic lesion generating system), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established through:

Engineering specifications and design parameters: For acoustic power output.
Physical measurements and objective testing: For targeting accuracy and thermal mapping.
Validation against established performance standards: To demonstrate equivalent performance to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. As the device is a physical medical instrument and not an AI/machine learning model, there is no "training set."

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

This information is not applicable. There was no training set for an AI/machine learning model.

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K Number

K070313

Device Name

MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Manufacturer

Date Cleared

2007-05-11

(99 days)

Product Code

LFL

Regulation Number

N/A

Type

Special

Panel

ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF

Reference & Predicate Devices

K050776

Intended Use

The Alliger Ultrasonic System is indicated for use in the fragmentation and aspiration of both 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.

Thoracic Surgery

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

Wound Care

The Misonix Inc. AUSS-7 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.

Device Description

The Alliger Ultrasonic Surgical System 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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
The AUSS-7 Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both 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

AI/ML Overview

This device, the Alliger Ultrasonic Surgical System Model AUSS-7, is cleared based on demonstrating substantial equivalence to a predicate device (Misonix Inc. Ultrasonic Surgical Aspirator AUS-6, K050776) rather than meeting predefined acceptance criteria through a full clinical study with specific performance metrics.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" presented as quantitative performance thresholds the device must meet, nor are there reported device performance metrics in comparison to such criteria.

Instead, the submission focuses on demonstrating that the new device (AUSS-7) is as safe and effective as the predicate device (AUSS-6). The "performance" is implicitly deemed acceptable if it's found to be substantially equivalent.

The document lists "Non-Clinical Tests Performed for Determination of Substantial Equivalence," which essentially serve as the basis for comparison and demonstrate that the AUSS-7 operates similarly to the AUSS-6. These include:

Non-Clinical Test	Purpose (Implied Acceptance)
Output Frequency Measurements	Demonstrate consistent operating frequency with predicate.
Output Power Measurements (No Load to Maximum Load)	Show comparable power delivery across various loads.
Tip Displacement Measurements	Ensure similar vibrational amplitude at the tip.
Irrigation Flowrate Measurements (Ultrasound On/Flush)	Verify consistent irrigation capabilities.
Life Tests	Ensure expected device durability and longevity.
Vacuum Flowrate and Pressure Measurements	Confirm effective aspiration performance.
Input Power Measurements	Show consistent power consumption.
EMI Tests	Demonstrate electromagnetic compatibility and safety.
Dielectric Tests on Mains and Patient Circuits	Ensure electrical safety and insulation integrity.
Software Validations	Verify proper functioning of microprocessor controls, displays, and alarms.

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

Sample Size: Not applicable. No "test set" of clinical data was used for this 510(k) submission, as no clinical studies were performed. The evaluation was based on non-clinical engineering tests.
Data Provenance: Not applicable.

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

Not applicable. No clinical test set requiring expert ground truth was utilized.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Discussions of Clinical Tests Performed: N/A".

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

Yes, in a way. The "performance" evaluated was entirely standalone, as it relates to the device's physical and electrical characteristics and not to human-in-the-loop performance with a clinician. The non-clinical tests assess the device's intrinsic operational performance.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been engineering specifications, design requirements, and the performance characteristics of the predicate device (AUSS-6). The new device's measurements were compared against these established benchmarks.

8. The Sample Size for the Training Set

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

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

Not applicable.

Summary of the Study (Basis for Substantial Equivalence):

The "study" in this context is a series of non-clinical engineering tests and a comparison to a legally marketed predicate device.

Rationale for Equivalence: Misonix, Inc. concluded that the Alliger Ultrasonic System Model AUSS-7 is substantially equivalent to the AUSS-6 because:
- It is identical in its mode of operation.
- It has identical Indications for Use.
- The main differences are updated controls, displays, alarms (microprocessor-controlled, LCD screen), and a different outer housing for cosmetic purposes.
- A comprehensive set of non-clinical tests (listed above in point 1) were performed to confirm that the new design maintains equivalent performance characteristics (output frequency, power, tip displacement, flow rates, electrical safety, software validation, etc.) to the predicate device.
- No new safety or efficacy concerns were identified through risk analysis and voluntary consensus standard investigations.

A clinical study was explicitly not performed or required for this 510(k) clearance, as the changes to the device were deemed minor enough that non-clinical data was sufficient to demonstrate substantial equivalence to the predicate.

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K Number

K062471

Device Name

Manufacturer

Date Cleared

2006-10-26

(63 days)

Product Code

LFL,GEI

Regulation Number

N/A

Type

Panel

MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM

Reference & Predicate Devices

K050776,K012028,K051947

Intended Use

The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is 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 Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.

Device Description

The FS 1000 RF Ultrasonic Surgical Aspirator System is comprised of a generator, which feeds a 23 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. An aspirator system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of design, materials, and operating parameters. It does not present a study with acceptance criteria and device performance in the way that would be expected for a diagnostic AI or machine learning device.

Therefore, I cannot provide the requested information for an "AI or machine learning device" as the document describes a traditional surgical aspirator system. The questions about AI, reader studies, ground truth establishment, training sets, and sample sizes for diagnostic performance are not applicable to the content provided.

However, I can extract the information related to the device's performance based on the provided document, interpreting "acceptance criteria" as the voluntary standards it was tested against and "reported device performance" as the assertion of substantial equivalence based on meeting those standards and direct comparison to predicate devices.

Non-AI/ML Device Acceptance Criteria and Performance (Based on K062471)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Designed and tested to pass this standard.
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Designed and tested to pass this standard.
EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of High Frequency Surgical Equipment	Designed and tested to pass this standard.
EN 60601-1-2:2001 Electromagnetic Compatibility	Designed and tested to pass this standard.
FCC Part 18 EMC Requirement (Electromagnetic Compatibility)	Designed and tested to pass this standard.
Other Non-Clinical Tests (to demonstrate Substantial Equivalence)	Performed and deemed acceptable to support substantial equivalence.
Output Frequency Measurements	Performed.
Output Power Measurements (No Load to Maximum Load)	Performed.
Tip Displacement Measurements	Performed.
Irrigation Flowrate Measurements (Ultrasound On and Flush Mode)	Performed.
Life Tests	Performed.
Acoustic Output Test	Performed.
Vacuum Flowrate and Pressure Measurements	Performed.
Input Power Measurements	Performed.
EMI Tests	Performed.
Dielectric Tests on Mains Circuits	Performed.
Patient Current Leakage and Patient Sink Current Measurements	Performed.
Power Line Ground Leakage Measurements	Performed.
Dielectric Tests on Patient Circuits	Performed.
RF Cautery Life Tests	Performed.
Dielectric Tests with RF Cautery Unit Attached	Performed.
RF Cautery Unit Output Power Tests	Performed.
Software Validation	Software validations reviewed and cleared under 510(k) K032690; not affected by change of indication for use.
Sterilization Validations	Validation statements contained in Exhibit J.

Since this is a filing for a traditional surgical device and not an AI/ML diagnostic, the following questions are not directly applicable to the content provided in the 510(k) summary. I will state why for each:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable to this document. This document describes non-clinical engineering and performance testing against standards, and a comparison of physical device characteristics to predicate devices. There is no "test set" of patient data in the context of diagnostic performance.

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)

Not applicable to this document. There is no "test set" requiring expert ground truth in the context of diagnostic assessment. The "ground truth" for non-clinical engineering tests would be the established scientific and engineering principles and the specifications of the device/standards.

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

Not applicable to this document. No diagnostic test set requiring adjudication is described.

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 to this document. This is a surgical device, not a diagnostic imaging AI. No MRMC study or AI assistance is mentioned.

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

Not applicable to this document. This is not an algorithm-only device. It is a manually operated surgical tool.

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

Not applicable to this document in the diagnostic sense. For the engineering tests, the ground truth would be the validated measurements, specifications, and performance against established engineering standards. For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable to this document. There is no "training set" as this is not an AI/ML device.

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

Not applicable to this document. There is no "training set" as this is not an AI/ML device.

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K Number

K042096

Device Name

Manufacturer

Date Cleared

2006-01-26

(540 days)

Product Code

NTB

Regulation Number

878.4400

Type

Panel

MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY

Reference & Predicate Devices

K983214,K993944,K003978,K011074,K901540

Intended Use

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.

Device Description

Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The fluid is contained by a flexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.

In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.

AI/ML Overview

The Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is an ultrasonic surgical system designed for the laparoscopic or intraoperative ablation of soft tissue. The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study report in the way a clinical trial might. Therefore, the information typically found in acceptance criteria and study design for AI/CADe devices, such as sensitivity, specificity, or reader performance, is not directly applicable or available in this document.

However, based on the provided text, we can infer the "acceptance criteria" were related to safety and engineering performance, and the "study" involved non-clinical tests to demonstrate that the device met these engineering and safety standards and was substantially equivalent to existing devices.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Voluntary Standards" and "Non-Clinical Tests for Determination of Substantial Equivalence." These effectively serve as the acceptance criteria and the methods used to demonstrate performance for pre-market notification (510k) of this type of medical device.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance (Summary from document)
Safety Standards	UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	"designed to and will be tested to pass"
	EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	"designed to and will be tested to pass"
	FCC Part 18 EMC Requirements	"designed to and will be tested to pass"
	EN 60601-1-2:2001 Electromagnetic Compatibility	"designed to and will be tested to pass"
Non-Clinical Engineering Performance	Output Frequency Measurements	Performed, results led to conclusion of substantial equivalence.
	Output Power Measurements	Performed, results led to conclusion of substantial equivalence.
	Focal Length Accuracy Measurements (Schlieren Photos)	Performed, results led to conclusion of substantial equivalence.
	Life Tests	Performed, results led to conclusion of substantial equivalence.
	Input Power Measurements	Performed, results led to conclusion of substantial equivalence.
	EMI Tests	Performed, results led to conclusion of substantial equivalence.
	Dielectric Tests on Mains Circuits	Performed, results led to conclusion of substantial equivalence.
	Patient Current Leakage and Patient Sink Current Measurements	Performed, results led to conclusion of substantial equivalence.
	Power Line Ground Leakage Measurements	Performed, results led to conclusion of substantial equivalence.
	Dielectric Tests on Patient Circuits	Performed, results led to conclusion of substantial equivalence.
Sterilization/Disinfection	Sterilization or Disinfection Protocol Validation for all Reusable Components	Performed. "Validation statements are contained in Exhibit J."
Performance Modeling/Accuracy	In Vitro Targeting Accuracy Measurements	Performed, results led to conclusion of substantial equivalence.
	Computer Modeling of Lesion Creation vs Time and Focal Depth	Performed, results led to conclusion of substantial equivalence.

The document concludes that "Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent" to the predicate devices. This implies that the device successfully met the criteria in all the listed tests and analyses.

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

Sample Size for Test Set: Not applicable in the context of this device and report. The tests conducted were non-clinical engineering and performance characterization tests, not studies on a "test set" of patient data.
Data Provenance: Not applicable. The tests were conducted internally by the manufacturer (Misonix, Inc.) through "Output of Engineering Tests," "FMEA Analysis," and investigations into "Voluntary Consensus Standard."

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

Not applicable. Ground truth, in the sense of expert consensus on patient data, is not mentioned as part of the 510(k) submission for this device, which relies heavily on engineering and performance testing against established standards and comparison to predicate devices. The "ground truth" here would be the physical properties and performance parameters measured in a lab setting.

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

Not applicable. There was no "test set" of patient cases requiring expert 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 lesion generating system, not an AI/CADe diagnostic tool that would involve human readers or image interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.

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

Not applicable. There is no algorithm for diagnostic interpretation in this device. The device itself performs the therapeutic function, with operator control. The document explicitly states: "There is no software associated with this product."

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

The "ground truth" for the non-clinical tests would have been engineering specifications, physical measurements, and compliance with recognized voluntary standards. For example, for "Focal Length Accuracy Measurements," the ground truth would be the accurately measured focal length of the device compared to its design specification. For "In Vitro Targeting Accuracy Measurements," the ground truth would be the actual ablated tissue volume/shape in an in vitro model compared to the intended or predicted ablation.

8. The sample size for the training set

Not applicable. As noted, there is no software or AI component that would require a training set.

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

Not applicable. No training set exists.

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K Number

K052702

Device Name

Manufacturer

Date Cleared

2005-11-21

(54 days)

Product Code

GEI

Regulation Number

878.4400

Type

Panel