(158 days)
The Tenex® 2nd Generation System 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® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
The Tenex 2nd generation system 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 diabetic ulcers. The Tenex 2nd generation system is intended for use in an office-based setting, clinical or hospital environment. The system consists of a Console, ultrasonic MicroTips, a Foot Switch and a number of accessories.
The Console includes a touch screen tablet with a graphical user interface, motors to drive diaphragm pumps in the MicroTip, ultrasonic driver electronics and Software. The Console generates the ultrasonic energy required to operate the MicroTips and manages irrigation fluids. The Console is non-sterile when used and does not require processing.
The MicroTips connect to the Console for electrical power and to facilitate the transfer of irrigation fluid from the saline bag to the surgical site, and then aspirate the emulsified tissue and fluid to a collection bag incorporated into single use, disposable the MicroTip assembly. Motors in the Console couple to the diaphragm pumps in the MicroTips to control the fluid flows. The MicroTips are constructed from various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone.
The MicroTips are single use and sterile packaged. They are sterilized via gamma irradiation. The MicroTips are the ultrasonic surgical hand pieces that house the transducers, horns and needles with beveled tips.
The Foot Switch is used by the user to remotely control the Console. It connects to the back of the Console via an electrical cable. It provides on/off functionality for cutting, irrigation, and aspiration. The Foot Switch is IPX8 rated for protection against liquids.
The System includes additional components. a Packaging Hard Case is provided for shipping, handling. and storage of the Console, and a power cord is provided for connecting the Console to facility electrical power to operate the device. These items are non-sterile when used and do not require processing.
Associated accessories include: a USB Flash Drive for saving procedure information, USBC-HDMI cable for connecting to an external display, and a USB-Smartphone adaptor for connecting USB output to a smartphone.
The provided text is a 510(k) summary for the Tenex® 2nd Generation System, an ultrasonic surgical instrument. It details the device's characteristics, intended use, and non-clinical performance testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in a format allowing a table of acceptance criteria vs. reported performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Tenex Health TX System with the TXP MicroTip, K181367) through a comparison of technical characteristics and non-clinical performance testing against various standards.
Here's an attempt to extract and interpret the requested information based on the provided text, while noting what is not present:
Missing Information in the Provided Text:
- Specific Quantitative Acceptance Criteria: The document describes types of tests performed (e.g., Aspiration, Irrigation, MicroTip strength) and mentions the system "met requirements" or "met the standards," but it does not specify the quantitative performance metrics (e.g., "Aspiration volume must be >X cc/min" or "MicroTip strength must withstand Y force").
- Reported Device Performance against specific criteria: Without specific acceptance criteria, corresponding reported device performance against those criteria cannot be tabulated directly.
- Detailed Study Protocol for Performance Evaluation: The text lists various non-clinical performance tests but does not provide details of a single, comprehensive study with a defined sample size, ground truth, or expert involvement to "prove" the device meets acceptance criteria in a comparative sense.
- Sample size for test set with data provenance: While "simulated use testing in bovine tissue" and "simulated use testing in cadaver" are mentioned, the specific sample sizes for these tests are not provided. Data provenance is implied to be laboratory/simulated.
- Number of experts and qualifications for ground truth: Not mentioned, as the focus is on engineering and standard compliance rather than clinical interpretation.
- Adjudication method: Not applicable as no expert review process for ground truth is described.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not likely relevant for a device of this type, which is a surgical instrument rather than an AI-powered diagnostic tool.
- Standalone (algorithm-only) performance: Not mentioned. The device's software is for control and interface, not for standalone diagnostic or analytical performance.
- Type of ground truth used: For the non-clinical tests, the "ground truth" would be the known physical properties and performance characteristics of the materials and systems under test, not clinical outcomes or pathology.
- Sample size for training set: Not applicable, as this is not an AI/ML device in the context of a training set for a diagnostic algorithm.
- How ground truth for training set was established: Not applicable.
Extracted Information (with caveats):
1. A table of acceptance criteria and the reported device performance
As noted, explicit quantitative acceptance criteria are not provided. The document states that the Tenex® 2nd Generation System "met all specified performance requirements" and "adheres to industry standards." The table below attempts to infer criteria based on the comparisons made with the predicate device and the non-clinical tests.
| Characteristic / Test | Acceptance Criteria (Inferred from comparisons & standards) | Reported Device Performance |
|---|---|---|
| Operational Specs (compared to predicate) | ||
| Cutting levels | User selected: low, medium, and high (updated ultrasonic driver) | Met stated levels, enhanced control of power/acoustics |
| Irrigation flow control | User controllable, forced delivery of saline from external bag | Enhanced to stabilize flow rate, using fluid pump |
| Irrigation flow rates | In excess of 60 cc/min (enhanced from >30 cc/min) | In excess of 60 cc/min |
| Aspiration flow control | User controllable, suction provided by vacuum pump | Enhanced pump |
| Aspiration flow rates | User selectable, 3 levels between 100-200 cc/min (enhanced from 10-30 cc/min) | User selectable, 3 levels between 100-200 cc/min |
| Aspiration potential (vacuum pressure) | User selectable, 3 levels between 0-520 mmHg (enhanced from 100-500 mmHg) | User selectable, 3 levels between 0-520 mmHg |
| MicroTip Case Nose | Biocompatible polymer over-molding (e.g., ABS) | ABS over-molded stainless-steel sheath |
| Tip diameters | Multiple, between 1.5 - 1.9mm (improved strength/durability) | Between 1.5 - 1.9mm |
| Tip lengths | Multiple, between 1.0 - 3.0 in (improved depth of reach) | Between 1.0 - 3.0 in |
| User Interface | Color touchscreen, higher resolution, greater processing power | Color touchscreen (internal MS Tablet), higher resolution, greater processing power |
| Software/Firmware | Improved programming, display, and interface options with current technology | Windows OS; interfaces with firmware on DSP Microcontroller |
| Ultrasonic driver | Digital Voltage and Frequency Controlled (enhanced control of power/acoustics) | Digital Voltage and Frequency Controlled |
| Non-Clinical Performance Tests | ||
| Electro-mechanical bench testing | System met requirements for listed functions (Aspiration, Irrigation, MicroTip strength, etc.) | Met all requirements for: Aspiration, Irrigation, Cassette attachment/detection, Console functions, Console life cycle, Environmental ops, Hardware verification, MicroTip functions, MicroTip strength, Transit conditions. |
| EMC and electrical safety testing | Compliance with IEC 60601-1:2005+A1:2012+A2:2020 and IEC 60601-1-2:2014+A1:2021 | Met all standards. |
| Software V&V | Compliance with IEC 62304:2006/A1:2016 | Developed, verified, and validated per standard. |
| Biocompatibility evaluation | Compliance with ISO 10993-1:2018 | Met standard. |
| Sterilization validation | Compliance with ISO 11137-1, ISO 11137-2 | Met standards. |
| Packaging & Shelf Life Validation | Compliance with ISO 11607-1, ISO 11607-2 | Met standards. |
| Simulated use testing (bovine tissue) | System performance and durability in tissue validated. | System performance and durability validated. |
| Simulated use testing (cadaver) | System design and usability validated, compliance with IEC 60601-1-6, ANSI AAMI IEC 62366-1 | Design and usability validated. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated for any of the non-clinical tests (e.g., number of bovine tissue samples, number of cadavers, or number of units tested for electro-mechanical benchmarks).
- Data Provenance: The data originates from internal non-clinical performance testing conducted by the manufacturer (Trice Medical, Inc.), involving simulated environments (bovine tissue, cadaver) and laboratory bench tests. Implied to be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not specified. For this type of device, ground truth for bench testing refers to engineering specifications and standard compliance, not clinical expert consensus. For usability testing (simulated use in cadaver), it implies evaluation by users (e.g., surgeons), but specific numbers or qualifications are not provided.
4. Adjudication method for the test set
- Adjudication method: Not applicable/not described as there isn't a stated panel review process for establishing ground truth in the context of this submission. The tests are against predefined engineering and regulatory standards.
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, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging software or AI tools, not for a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone (algorithm only) performance study was not conducted. The software in the Tenex® 2nd Generation System operates the device and interfaces with the user, it does not perform an independent function that would require "standalone" performance evaluation in the context of diagnostic AI.
7. The type of ground truth used
- Type of Ground Truth: For the non-clinical performance tests, the "ground truth" is based on:
- Engineering specifications and requirements: For electro-mechanical bench testing, software V&V.
- International standards: For EMC, electrical safety, biocompatibility, sterilization, packaging, and shelf-life validation.
- Expected physical and functional performance: For simulated use testing in bovine tissue and cadaver, validating that the device performs its intended functions (fragmentation, emulsification, aspiration) effectively and is usable.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is an electromechanical surgical instrument with controlling software, not an AI/ML diagnostic system 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 an AI/ML algorithm.
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