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510(k) Data Aggregation
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
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
| 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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