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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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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.

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.

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

Study Details (Based on Substantial Equivalence Claim)

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.

6. 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.

7. 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.

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

   • Not applicable. See above.

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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.

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.

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.

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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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.

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

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:

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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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.

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.

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

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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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.

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.

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.

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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The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities:

Neurosurgery Plastic and Reconstructive Surgery General Surgery

Metal and plastic construction that approximates a tweezer assembly. Includes provision for connection to the output of a standard bipolar electrosurgical generator. Also includes provision for mechanical attachment to an ultrasonic surgical aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory 510(k) summary provides information on the device's adherence to voluntary standards and non-clinical tests. This document does not describe an acceptance criteria table, a study explicitly proving the device meets said acceptance criteria, or details regarding sample sizes, ground truth establishment, or human-in-the-loop studies as typically expected for imaging algorithm performance.

However, based on the provided text, we can infer the acceptance criteria are met by the successful completion of various safety and performance tests to established voluntary standards.

Here's a breakdown of the information requested, as far as it can be extracted and inferred from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes voluntary standards and non-clinical tests rather than a specific acceptance criteria table with numerical targets. The "performance" is reported as having successfully passed these tests.

The general conclusion, based on these tests and a review of published literature, is that the device is "safe and efficacious" and "substantially equivalent" to predicate devices.

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

• Sample Size for Test Set: Not specified. The document mentions "testing was done while attached to standard electrosurgical generator" and "testing of bipolar effect on animal tissue (bench top)". It does not provide numerical sample sizes for these tests.
• Data Provenance: The tests are described as "internal testing" and "in vitro tests performed". "Animal tissue (bench top)" is mentioned for the in vitro tests. The country of origin is not specified but is presumably the US, given the submission to the FDA. The tests are prospective as they were conducted specifically for this submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document mentions a "Surgeon assisted trial on animal tissue (bench top) for clinician feedback." This implies input from at least one surgeon, but specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.

4. Adjudication Method for the Test Set

Not applicable/specified. The document does not describe a clinical study with a test set requiring adjudication. The tests mentioned are primarily engineering and bench-top evaluations.

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

No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This is a medical device (forceps accessory), not an AI/software diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical electrosurgical accessory, not a software algorithm, so the concept of "standalone algorithm performance" does not apply. The device's performance is inherently "with human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

For the non-clinical and in vitro tests, the "ground truth" would be the expected performance according to the voluntary standards (e.g., specific thresholds for leakage current, dielectric strength) and the observable effects on animal tissue in bench-top settings (e.g., successful coagulation, lack of tissue adhesion). It is based on engineering measurements and physical observation/outcomes in a controlled environment as opposed to expert consensus, pathology, or clinical outcomes data from human subjects.

8. The Sample Size for the Training Set

Not applicable. As this is not a machine learning or AI-driven device, there is no "training set."

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

Not applicable, as there is no training set.

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The AUSS-6 Ultrasonic Surgical Aspiration System and Accessories are indicated for the fragmentation and aspiration of soft and hard (i.e. bone) tissues in various General and Specialty surgery applications. It 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.

The Alliger AUSS-6 Ultrasonic Surgical System and Accessories are 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-6 Utrasonic 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 judgement would require the use of an ultrasonic aspirator with sharp debridement.

The AUSS-6 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. 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 probe tips, wrenches, sterile and non sterile tube sets and sterile Surgical Procedure bags.

The Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator System and Accessories is a medical device for fragmentation and aspiration of soft and hard tissues in various surgical applications, and for wound debridement.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as numerical data. The submission refers to "several papers" and "clinical tests for Wound Debridment" outlined in Exhibit L. The nature or size of these clinical tests/studies is not detailed in the provided summary.
• Data Provenance: The document states that Ultrasonic Surgical Aspirators have been employed for 30 years and are "well documented in the public domain." For wound debridement, "published literature" and "clinical tests for Wound Debridment" (Exhibit L) were used. The country of origin is not specified but given the context of FDA submission, it would likely be studies from North America or globally recognized literature. The studies appear to be a mix of retrospective (published literature review) and prospective (the "clinical tests" for AUSS-6).

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):

• This information is not provided in the summary. The clinical data relies on "published literature" and "clinical tests," but details about expert involvement in establishing ground truth are absent.

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

• This information is not provided in the summary.

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 or human-AI comparison study was done. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool for human readers.

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

• This question is not applicable. The device is a physical surgical instrument, not an algorithm.

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

• For the general efficacy and safety of ultrasonic surgical aspirators in soft and hard tissue ablation, the "ground truth" is based on long-standing clinical use and published literature.
• For the wound debridement indication, the "ground truth" is derived from published literature discussing the use of ultrasonic surgical systems for debriding wounds, and the results of "clinical tests" on the AUSS-6 device for wound debridement. This implies an assessment of clinical outcomes. Further specifics on how "safe and efficacious" was defined as ground truth (e.g., specific healing rates, reduction in infection, etc.) are not detailed in this summary, but would be expected in Exhibit L.

8. The sample size for the training set:

• This question is not applicable. The device is a physical surgical instrument, not a machine learning algorithm that requires a training set.

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

• This question is not applicable (as above).

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LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

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 / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.

The provided FDA 510(k) summary for the Misonix Inc. LYSONIX 2000/3000 Ultrasonic Surgical Aspirator Systems focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data from a clinical study.

Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document. The 510(k) process for this device relies on proving that the new device is as safe and effective as existing legally marketed devices, often through comparison of design, materials, and operating parameters, and adherence to voluntary standards.

Here's an attempt to answer what can be extracted from the document, along with explanations for what is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated as acceptance criteria for specific performance metrics in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.

• Acceptance Criteria (Implied/General): The device is substantially equivalent to legally marketed predicate devices regarding design, materials, operating parameters, and intended use. It also meets voluntary safety and EMC standards.
• Reported Device Performance:
  • Intended Use: Liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery Applications. Also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for aesthetic body contouring.
  • Operating Parameters: Generates a 22.5 kHz electrical signal, piezoelectric crystals vibrate at the same frequency, and a titanium tip amplifies the vibration. Irrigation/aspiration unit provided.
  • Safety/EMC: Designed and tested to pass UL 2601-1, EN 60601-1, EN 60601-1-2 (for LySonix 2000/3000), and FCC Part 18 EMC Requirements.

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

• Sample Size: Not applicable/not provided. The submission does not describe a clinical "test set" in the context of performance metrics that would require a defined sample size (e.g., number of patients, images, or cases). Instead, it relies on comparison to predicate devices and adherence to engineering standards.
• Data Provenance: The document does not describe specific clinical data provenances (e.g., country of origin, retrospective/prospective) because it's not a clinical efficacy study involving patient data endpoints.

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

• Not applicable/not provided. Ground truth establishment by experts for a test set is not part of this 510(k) submission, as it's not a study evaluating diagnostic or treatment outcomes against a gold standard in a clinical population.

4. Adjudication method for the test set

• Not applicable/not provided. Adjudication methods are relevant for studies comparing interpretations or outcomes, which is not the focus of this 510(k) submission.

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. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not conducted.

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

• Not applicable. This device is a surgical instrument and does not feature algorithms that would perform "standalone" operations without human interaction in a diagnostic or interpretive sense. The document explicitly states: "This device does not contain software."

7. The type of ground truth used

• Not applicable/not provided for clinical outcomes. The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and the adherence of the new device to recognized voluntary safety and electromagnetic compatibility (EMC) standards. There is no mention of pathology, outcomes data, or expert consensus being used to establish ground truth for performance metrics of the device itself beyond its design and intended function as a surgical tool.

8. The sample size for the training set

• Not applicable/not provided. There is no "training set" in the context of an algorithm or machine learning for this type of device submission.

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

• Not applicable/not provided. As there is no training set mentioned, this question is not relevant.

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