(114 days)
The TX1 Tissue Removal System is intended for use as an Ultrasonic Surgical Aspirator of soft tissue.
The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
The TX 1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, and foot pedal. The console provides control over the four user functions including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. The console provides a connection for a commercially available cautery pencil or forceps. Two USB ports and one Ethernet port are available for loading software upgrades.
The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for removing 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 is 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 a cuff that is fitted around the irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the height of the fluid bag.
The foot pedal is used to control each of the four functions (irrigation, aspiration, ultrasonic fragmentation/emulsification, coagulation) of the system. It offers on/off functionality and is rated IPX5 (by the supplier) for protection against liquids.
This document covers the 510(k) summary for the Tenex Health TX1 Tissue Removal System, an ultrasonic surgical aspirator. The submission focuses on demonstrating substantial equivalence to a predicate device (K101561 TX1 Tissue Removal System) rather than presenting a de novo study with specific acceptance criteria for performance as would be expected for a novel device or AI/ML product.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly concerning human readers, AI assistance, ground truth, and training data, is not directly applicable to this 510(k) submission. This submission primarily relies on comparing technological characteristics and non-clinical performance tests to a predicate device.
However, I can extract information related to the non-clinical performance and the basis for the FDA's clearance.
1. Table of "Acceptance Criteria" and Reported Device Performance (interpreted from non-clinical tests for equivalence):
Since this is a 510(k) submission for an ultrasonic surgical aspirator, the "acceptance criteria" are not reported as numerical thresholds like accuracy or precision for an AI/ML device. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and biocompatibility standards, demonstrating equivalence to the predicate device. The reported "performance" is whether these tests were passed.
| Area of Assessment | Implicit Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|---|
| Functional Integrity | Maintain structural integrity under normal and stressed conditions | PASS |
| Integrity test – Case body/Case tail joint interface | (Specific criterion for joint integrity) | PASS |
| Functional verification – post sterilization | Function correctly after sterilization | PASS |
| Functional verification – accelerated aged conditioning | Function correctly after simulated aging | PASS |
| Functional verification – post transportation conditioning | Function correctly after simulated transportation stress | PASS |
| Cart strength verification | The cart (if applicable, implied for system stability) meets strength requirements | PASS |
| Electrical Safety & EMC | Comply with international electrical safety and electromagnetic compatibility standards (IEC 60601 series) | PASS |
| IEC 60601-1-2 (2004) | Meet EMC requirements | PASS |
| IEC 60601-1 (1999) | Meet general requirements for safety (including Amendments 1 & 2) | PASS |
| IEC 60601-2-2 (2006) | Meet particular requirements for safety of high-frequency surgical equipment | PASS |
| Biocompatibility | Be biologically safe when in contact with human tissue, as per ISO 10993 series | PASS |
| ISO 10993-1 (2009/Cor. 1:2010), -5 (2009), -10 (2010), -11 (2006) | Evaluation, in vitro cytotoxicity, irritation/sensitization, and systemic toxicity requirements | PASS |
2. Sample size used for the test set and the data provenance:
- This submission describes non-clinical performance tests for a physical medical device (ultrasonic surgical aspirator), not a software or AI/ML device relying on diagnostic images or patient data.
- Therefore, there is no "test set" in the context of clinical data, images, or patient cohorts. The "test set" refers to the device units and components undergoing the specified engineering, electrical, and biocompatibility tests.
- The document does not specify the number of units or components tested for each non-clinical test, nor does it specify data provenance (country of origin, retrospective/prospective) as these are not relevant for these types of engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. "Ground truth" in the context of expert review of data is irrelevant for the non-clinical performance tests of a physical surgical device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified standards (e.g., electrical resistance, mechanical strength, chemical reactivity).
4. Adjudication method for the test set:
- This is not applicable. Test results for engineering and safety standards are typically determined by objective measurements against predefined criteria, not by 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:
- This is not applicable. The device is an ultrasonic surgical aspirator, not an AI/ML diagnostic aid or image processing tool. No MRMC study was performed, nor is there any AI component to assess human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As noted, the device is a physical surgical tool, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is defined by the objective engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series). The device's performance against these standards determines if it "passes" or "fails."
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- This is not applicable.
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