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510(k) Data Aggregation
(242 days)
The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired.
-General Surgery
-Plastic and reconstructive Surgery
The Allegro is comprised of a power conditioner (110/120 volts AC), a microcomputer, a control panel, a signal generator, a BNC output, and a separate surgical handpiece. The power conditioner serves to buffer the system from commercial electrical discontinuities and provides a continuous electrical signal to Allegro's components. The microcomputer integrates Allegro's system components and provides a user-friendly control interface. The control panel provides for user input and system settings and displays. The signal generator creates electrical current in programmable waveforms (20-25 kHz). The BNC output connects the system to the surgical handpiece. The surgical handpiece contains the electromotive engine (piezoelectric ceramic stack), the infiltration/aspiration port, and the ultrasonic surgical probe. The electrical waveforms sent to the handpiece excite the motor stack and cause high-frequency, small amplitude motion of the ultrasonic surgical probe. Motion at the tip of the probe fragments local soft tissue, which is then aspirated through the probe.
This document is a 510(k) Summary for the CITEI Allegro Ultrasonic Soft Tissue Aspirator. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., accuracy, precision) for a diagnostic output. Instead, the "acceptance criteria" appear to be based on demonstrating comparability of key technical specifications and operational principles to legally marketed predicate devices. The "reported device performance" refers to these technical specifications.
| Acceptance Criteria (Implied by Predicate Device Comparison) | Reported Device Performance (Allegro Ultrasonic Soft Tissue Aspirator) |
|---|---|
| Electrical signal characteristics (amplitude, frequency) comparable to predicate devices. | Sinusoidal amplitude, 37-45 kHz (Note: the "Device Description" states 20-25 kHz, while non-clinical data states 37-45 kHz. There might be a discrepancy or different modes of operation. For this table, I'll use the non-clinical data which directly compares to predicate devices). |
| Motion at the probe tip comparable to predicate devices. | Motion at the probe tip ≥0 or ≤500 μm. Primarily vertical motion at 20-25 kHz. |
| Power consumption similar to predicate devices. | 0-100 watts. |
| Ultrasonic probe design and construction similar to predicate devices. | Titanium and/or stainless steel. |
2. Sample Size Used for the Test Set and Data Provenance:
No test set for evaluating the device's diagnostic or therapeutic efficacy is mentioned or implied. The data provided are non-clinical bench test data comparing the device's technical specifications to those of predicate devices. No patient or human subject data is used for this comparison. Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. There was no test set requiring expert-established ground truth. The comparison is based on technical specifications and engineering design data.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC comparative effectiveness study was done. This document pertains to a medical device's technical specifications and substantial equivalence, not an AI or diagnostic imaging product requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The Allegro Ultrasonic Soft Tissue Aspirator is a surgical instrument, not an algorithm or AI system.
7. The type of ground truth used:
Not applicable in the context of diagnostic performance. The "ground truth" for the non-clinical data is the measured technical specifications of the Allegro device, which are then compared to the known technical specifications of predicate devices to establish substantial equivalence.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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