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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.

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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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 TX1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, tube set, and foot pedal: The system has been designed to work with commercially available accessories and consumables including cautery pencils and forceps, ultrasonic handpiece tips, and silicone sleeves. The console provides control over the four modes of operation including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console also 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. Two USB ports are available for loading software upgrades. An Ethernet port is also available for future system expandability. The ultrasonic handpiece connects to the console for power. and to the tube set for both delivering irrigation fluid directly to the surgical site and for removing emulsified tissue. The handpiece is constructed from both 316L stainless steel and TiAl6V4 Titanium Alloy components, and can be sterilized by steam and reused multiple times. The tube set employs an external tubing cartridge design that can be easily installed or removed in a single step. The tubing is made of biomedical grade silicone. The tube set can be sterilized by steam and reused multiple times. Irrigation fluid is delivered under pressure to ensure adequate cooling of the ultrasonic tip, as well as adequate flushing of 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 of the system. Simple in design, it offers on/off functionality and is rated IPX5 for protection against liquids.

The provided text describes a 510(k) submission for a medical device, the TX1 Tissue Removal System, and focuses on demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to existing devices rather than a standalone clinical study to establish acceptance criteria based on performance. As such, the information you've requested regarding specific acceptance criteria metrics (like sensitivity, specificity), sample sizes, expert ground truth establishment, MRMC studies, or training set details is not present in the provided document.

The document states: "Independent, 3rd party electrical safety testing, adherence to U.S. FDA design control guidance, as well as thorough in-house, non-clinical (bench) testing and software validation provide reasonable assurance that the TX1 Tissue Removal System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device." This indicates that the "study" proving the device meets acceptance criteria was primarily focused on bench testing, software validation, and compliance with electrical safety standards and design control guidance, rather than a clinical trial with performance metrics.

Here's a breakdown of what can be extracted based on your request, with the understanding that many fields will be "Not Applicable" or "Not Provided" given the nature of a 510(k) substantial equivalence submission:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating comparable technological characteristics and intended use to a predicate device, along with adherence to relevant safety standards. "Reported device performance" would thus be a comparison of these characteristics.

Note on Acceptance Criteria: The acceptance criteria for a 510(k) are implicitly met if the new device demonstrates "substantial equivalence" to the predicate, meaning it has the same intended use and similar technological characteristics, or if differences do not raise new questions of safety or effectiveness. The table above summarizes how the device compares to the predicate on these characteristics.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission. No clinical "test set" (e.g., patient cases for diagnostic accuracy) is mentioned. The "testing" involved bench testing, software validation, and electrical safety testing. Details of these tests (e.g., number of units tested, duration of tests) are not provided in this summary.
• Data Provenance: Not applicable. The "study" was primarily engineering and regulatory compliance testing rather than clinical data collection from a specific country or retrospective/prospective design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. Ground truth for a diagnostic test set is not established here. The assessment is based on engineering specifications and performance against those specifications.
• Qualifications of Experts: The document mentions "Independent, 3rd party electrical safety testing" and "in-house, non-clinical (bench) testing and software validation." This implies qualified engineers and testers conducted these evaluations, but specific qualifications are not detailed.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no diagnostic test set requiring 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

• MRMC Study: No. This is not an AI-based device, nor is a clinical comparative effectiveness study described in this 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance: Not applicable. This device is an ultrasonic surgical aspirator, not an algorithm. Its "standalone" performance would be its functional operation in a surgical setting, which is inferred as equivalent to the predicate device through bench testing and design comparisons.

7. The type of ground truth used

• Type of Ground Truth: For the engineering and performance evaluations, the "ground truth" would be the established engineering specifications, performance parameters (e.g., maximum tip amplitude, vacuum levels), and electrical safety standards (e.g., IEC 60601-1). The device was tested to ensure it met these predefined technical requirements and performed comparably to the predicate on relevant parameters.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or an "AI" component that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model.

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