(111 days)
The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
The Tenex Health TX System is an ultrasonic surgical aspirator that fragments, emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, inflation cuff and foot pedal. The console provides control over the user functions including irrigation, aspiration, and ultrasonic fragmentation/emulsification. It has a large, color LCD and employs a touch-screen with a graphical user interface for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation valve, the irrigation pump, and the aspiration pump, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room.
The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for aspirating emulsified tissue by way of integrated tubing set. The handpiece is constructed from various polymers and metals, while the tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile. The handpiece and tubing are a single use disposable component of the system. Irrigation fluid is delivered under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes an inflation cuff that is filled around the irrigating fluid bag, thus providing irrigation at a fixed pressure.
The foot pedal is used to control each of the functions (irrigation, aspiration, ultrasonic fragmentation/emulsification) of the system. It offers on/off functionality and is rated IPX8 (by the supplier) for protection against liquids.
The provided document is a 510(k) summary for the Tenex Health TX System, an ultrasonic surgical aspirator. It describes the device, its intended use, and compares it to a predicate device (TX1 Tissue Removal System) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets in the way one might expect for a diagnostic or AI-driven device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the studies for the Tenex Health TX System are focused on verifying performance characteristics and functionality against engineering specifications and comparison to the predicate device.
The reported performance revolves around demonstrating that the new TX System performs comparably to the predicate TX1 system and meets safety and functional requirements.
| Performance Characteristic Verified | Reported Device Performance |
|---|---|
| Non-clinical Performance Tests (Quantitative) | |
| Stroke length determination | Tested and passed. (Implicitly met design specifications, but specific values are not provided) |
| Ultrasonic frequency | Tested and passed. (Implicitly met design specifications, expected to be 26.5±1.5KHz as per MicroTip characteristics) |
| Aspiration vacuum | Tested and passed. (Implicitly met design specifications) |
| Irrigation flow (free flow) | Tested and passed. (Implicitly met design specifications) |
| Irrigation flow (aspiration volume) | Tested and passed. (Implicitly met design specifications) |
| Operating frequency | Tested and passed. (Implicitly met design specifications) |
| Device operating temperature | Tested and passed. (Implicitly met design specifications) |
| Functional Verification (Simulated Use) | |
| Automated priming | Tested and passed. (Functionally verified) |
| Durability verification | Tested and passed. (Functionally verified) |
| Pull strength of metal sheath | Tested and passed. (Functionally verified) |
| Effectiveness of TX2 MicroTip to fragment, | Demonstrated effectiveness in fragmentation, emulsification, and removal of soft tissue and found to be comparable to the TX1 MicroTip. (Qualitative comparison inferred) |
| emulsify and remove soft tissue | |
| Design Validation (Simulated Use) | |
| Functional validation | Tested and passed. (Implicitly confirmed overall functional performance) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for a software or AI device. The tests described are laboratory-based engineering and functional tests performed on devices. Therefore, information about sample size for a "test set" for data and data provenance (country of origin, retrospective/prospective) is not applicable here. These are physical device tests, likely using a sample of manufactured units or components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is a physical medical device (ultrasonic surgical aspirator) and not a diagnostic AI system, the concept of "ground truth" derived from expert consensus on a test set (e.g., image annotations) is not applicable. The "ground truth" for these types of tests would be established by engineering specifications, validated test methods, and performance against the predicate device.
4. Adjudication Method
As the "test set" and "ground truth" in the context of AI are not applicable here, an adjudication method is also not applicable. Device performance is assessed against predefined engineering and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device submission. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the function of the Tenex Health TX System. The document focuses on demonstrating substantial equivalence in physical and functional characteristics to a predicate device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm is not applicable because the Tenex Health TX System is a physical surgical device, not a software algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications: Defined parameters for stroke length, ultrasonic frequency, aspiration vacuum, irrigation flow, operating frequency, and operating temperature.
- Voluntary Standards Compliance: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 61847, ISO 10993-1, ISO 11137-1, ISO 11737-1, ISO 11737-2, ISO 11607-1, and ISO 11607-2.
- Performance Comparison to Predicate: Demonstrating that the device's effectiveness in fragmentation, emulsification, and soft tissue removal is comparable to the legally marketed predicate device (TX1 Tissue Removal System).
8. Sample Size for the Training Set
The concept of a "training set" is not applicable for this physical medical device. This is not an AI or machine learning product.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of AI, this question is not applicable.
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