(49 days)
The intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System.
The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.
The OmniSonics Ultrasonic probes work in conjunction with the OmniSonics Ultrasonic Generator. The generator creates a specific electrical signal that is directed into the OmniSoncs ultrasonic handle. The signal is converted into an ultrasonic motion within the handle and this motion is transferred to the ultrasonic probe.
The ultrasonic energy in contact with the probe causes a specifically defined motion to occur on the probe shaft. The motion of the probe in contact with the tissue causes a localized cavitation, and immediate destruction of the tissue in contact with the probe. Cavitation is caused by the motion of the probe within water and in contact with tissue.
The motion of the probe causes the formation of microbubbles to be formed. The upstoke of the probe causes the formation of the bubble behind the probe, the downstroke causes the collapse of the bubble and a small localized shock wave. This focused wave formed at the tip of the probe causes a localized and focused shock wave to be formed which impinges upon the tissue and breaks off the most least tightly bound tissue layer. The action is limited to a specific contact area of the probe upon the tissue, and does not travel beyond these contact points.
The OmniSonics Ultrasonic Probes are constructed of titanium and are all specifically designed for use and operation with the OmniSonics Ultrasonic Surgical System.
The specifications of the proposed OmniSonics Ultrasonic Probes are the following:
Diameter Exterior: 1 mm - 10 mm
Diameter Interior: .5 mm - 8 mm
Length: 10 mm - 30 mm
The provided text is a 510(k) summary for the OmniSonics Ultrasonic Probes. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria for a novel device or AI algorithm.
Due to the nature of a 510(k) submission for a non-AI/software device from 1999, the information typically requested in your prompt regarding AI/software performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and effect sizes) is not applicable and not present in this document.
The document does mention performance testing in a general sense, but not in the detailed, quantitative manner you're looking for an AI/software product.
Here's a breakdown of what information can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one would for an AI/software device. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "performance testing" section is very brief and general.
| Criteria (Implied from 510(k)) | OmniSonics Ultrasonic Probes Performance (as stated in document) |
|---|---|
| Biocompatibility | Materials used are biocompatible. |
| Sterilization | Sterilized to an SAL of 10⁻⁶ in accordance with AAMI guidelines for ETO sterilization. |
| Electrical Safety | Tested in compliance with IEC 60601. |
| Technological Characteristics | |
| Principle of Operation | Localized cavitation and immediate tissue destruction via ultrasonic motion similar to predicates. |
| Materials | Titanium, similar to predicate devices (metal alloy). |
| Configuration | Various configurations, lengths, diameters, similar to predicate devices. |
| Energy Source | Uses an external ultrasonic handpiece, similar to predicate devices. |
| Intended Use | Breakup and removal of soft tissues in Neurosurgery, GI, Urology, General, Plastic, Orthopedic, GYN, Thoracic surgery, similar to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a test set of data as would be used for an AI/software device. The "performance testing" mentioned refers to non-clinical testing (biocompatibility, sterilization, electrical safety).
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 / Not provided. No clinical "test set" requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical "test set" and thus no adjudication method 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 / Not provided. This is a hardware device, not an AI or software product. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. No clinical ground truth is discussed in relation to "performance" in the context of an AI/software test. The "performance testing" refers to compliance with standards (IEC 60601) and material properties (biocompatibility, sterilization), which have their own established methods of verification, rather than clinical ground truth as you'd define it for an AI.
8. The sample size for the training set
- Not applicable / Not provided. This is a hardware device, not an AI/software product, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set exists for this hardware device.
Summary of Device-Specific Information from the Text:
- Device Name: OmniSonics Ultrasonic Probes
- Manufacturer: OmniSonics Medical Technologies, Inc.
- Intended Use: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. Used in conjunction with the OmniSonics Ultrasonic Surgical System.
- Predicate Devices: Sonokinetics SONOTOME System (K990572) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262).
- Principle of Operation: Converts electrical signal to ultrasonic motion via the handle, transferred to the probe. The motion causes localized cavitation and immediate tissue destruction due to microbubble formation, collapse, and localized shockwaves.
- Materials: Titanium.
- Specifications:
- Diameter Exterior: 1 mm - 10 mm
- Diameter Interior: 0.5 mm - 8 mm
- Length: 10 mm - 30 mm
- Regulatory Class: II
- Product Code: LFL
- Date of Submission: October 23, 1999
- FDA Clearance Date: December 15, 1999 (K993628)
Conclusion:
This 510(k) submission for the OmniSonics Ultrasonic Probes is for a physical medical device (ultrasonic probes) and demonstrates "substantial equivalence" to existing, legally marketed predicate devices. It does not contain information related to AI/software performance studies, test sets, training sets, ground truth establishment, or expert reviews as these concepts are not relevant to this type of device and submission. The "performance testing" refers to standard compliance for safety and material properties.
N/A