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The Tenex Health TX System with the TXP MicroTip is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The Tenex Health TX System with the TXP MicroTip is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

The Tenex Health TX System with the TXP MicroTip is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic ulcers. The Tenex Health TX System with the TXP MicroTip is intended for use in an office-based setting, clinical environment or hospital environment. The system consists of a console, ultrasonic MicroTip, inflation cuff, foot pedal and supply kit. The console provides power and control for 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. The Console is non-sterile when used and does not require processing.

The ultrasonic MicroTip connects to the console for electrical power, the transfer of irrigation fluid to the surgical site and the aspiration of emulsified tissue back to the collection bag. The MicroTip is single use, sterile packaged. A single use, disposable collection bag is integrated into the MicroTip tubing to collect the aspirated materials. The connections are made via an integrated wiring connector and tubing set. The handpiece is constructed from various biocompatible polymers and metals. The tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile, via electron beam irradiation. The handpiece and tubing are a single use disposable component of the system. Irrigation fluid is delivered from a user-provided surgical saline bag, 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 fitted over the saline bag.

The foot pedal is used by the user to remotely control the function of the console. It connects to the back of the console via an electrical cable. It provides on/off functionality and is rated IPX8 for protection against liquids.

The System also includes accessories. A Travel Case is provided for shipping, handling and storage of the TX Console. A power cord is provided for connecting the Console to facility electrical power in order to operate the device. A replacement fuse set is also provided in case of the need for replacement of electrical fuses in the TX Console. The accessories are non-sterile when used and does not require processing.

The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. These include a syringe and needle, scalpel, an ultrasound probe cover, gauze, closure strips and dressing. The itemized contents of the kit with their manufacturer and regulatory information are provided in Table 4 below.

The Tenex Health TX System with the TXP MicroTip is an upgrade to the Tenex Health TX System (K153299), with the addition of the TXP MicroTip, an upgraded handpiece with indications for use for the treatment of hard tissue and the sharp debridement of wounds such as neuropathic ulcers.

The provided text is a 510(k) Summary for the Tenex Health TX System with the TXP MicroTip. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML or human reader performance.

The "Performance Data" section details non-clinical performance tests which include:

• Electro-mechanical bench testing (e.g., aspiration vacuum, irrigation flow, operating frequency, needle stroke length)
• EMC and electrical safety testing
• Biocompatibility evaluation
• Sterilization validation
• Packaging Validation
• Simulated use testing in cadaver (evaluating design, usability, surgical technique, and effectiveness in sharp debridement of soft and hard tissue in wounds)
• Simulated use testing in bovine tissue (validating durability, cutting, fragmentation, emulsification, aspiration, and quantifying tissue removal rates)

These tests are primarily focused on the physical and functional aspects of the surgical device, its safety, and its ability to perform its intended mechanical actions (fragmentation, emulsification, aspiration of tissue). There is no mention of an AI/ML component, diagnostic accuracy studies, or human reader performance studies (MRMC studies).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance related to AI/ML or diagnostic accuracy.
2. Sample size for a test set in the context of AI/ML, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, or ground truth for such studies.
3. Training set details related to AI/ML.

The device is a physical surgical instrument, not a diagnostic or AI-based software device. My capabilities are limited to extracting and rephrasing information explicitly present in the provided text.

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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.

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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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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