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.

Device Description

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.

AI/ML Overview

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.

Characteristic	Acceptance Criteria (Predicate Device K021989)	Reported Device Performance (TX1 Tissue Removal System)
Indications for Use	Fragmentation, emulsification, and aspiration of soft tissue desirable in surgical procedures.	Fragmentation, emulsification, and aspiration of soft tissue desirable in surgical procedures.
Method of tissue emulsification	Ultrasonic energy	Ultrasonic energy
Material in contact with tissue	TiAl6V4 Titanium Alloy	TiAl6V4 Titanium Alloy
Electrical safety standards met	60601-1, 60601-1-2, CSA 22.2 #601-1	60601-1, 60601-1-2, 60601-2-2
Power source	100-240V 50/60Hz	100-240V 50/60Hz
Frequency	24 kHz and 35 kHz	28 kHz
Tip Amplitude	Max 24 kHz: 305µm, Max 35 kHz: 215µm	Max 255µm
Method of aspiration (vacuum)	Venturi pump	Peristaltic pump
Vacuum level	0 to 600 mmHg	100, 300, or 500 mmHg
Method of irrigation	Constant flow	Constant Pressure
Irrigation flow	0 to 50 cc/min	10, 20, or 30 cc/min
Display	7 segment, manual pushbutton	Articulating, LCD Touch Screen

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.

Summary

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K101561

510(k) Summary

510(k) Submitter/ Owner

Contact person

Date prepared

Trade name

Common name

Classification

Predicate device

Device description

American Optisurgical Inc. 25501 Arctic Ocean Lake Forest. CA 92630 Voice: (949) 580-1266 Fax: (949) 580-1270

David Salzberg Director of Regulatory Affairs American Optisurgical, Inc. Email: regulatory@optisurgical.com

06/02/10

TX1 Tissue Removal System

Ultrasonic Surgical Aspirator

Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code LFL)

K021989, Selector Integra Ultrasonic Surgical Aspirator

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.

AUG 27 2010

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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.

NOTE: The device is essentially the same device cleared to market under 510(k) K080803. with changes made to the frequency range, irrigation system, foot pedal, software, labeling, and console color.

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 has similar technological characteristics as the predicate device cleared under 510(k) K021989. A summary is as follows:

Intended use

Technological characteristics

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DeviceCharacteristics	Subject DeviceTX1 Tissue Removal System	Predicate DeviceSelector® Integra UltrasonicSurgical Aspirator
Indications for use	The TX1 is indicated for use insurgical procedures wherefragmentation, emulsification,and aspiration of soft tissue aredesirable.	The Selector® is indicated foruse in surgical procedures wherefragmentation, emulsification,and aspiration of soft tissue aredesirable.
Display	Articulating, LCD Touch Screen	7 segment, manual pushbutton
Power source	100-240V 50/60Hz	100-240V 50/60Hz
Method of tissueemulsification	Ultrasonic energy	Ultrasonic energy
Frequency	28 kHz	24 kHz and 35 kHz
Tip Amplitude	Max 255µm	Max 24 kHz: 305µmMax 35 kHz: 215µm
Method ofaspiration (vacuum)	Peristaltic pump	Venturi pump
Vacuum level	100, 300, or 500 mmHg	0 to 600 mmHg
Method of irrigation	Constant Pressure	Constant flow
Irrigation flow	10, 20, or 30 cc/min	0 to 50 cc/min
Material in contactwith tissue	TiAl6V4 Titanium Alloy	TiAl6V4 Titanium Alloy
Electrical safetystandards met	60601-160601-1-260601-2-2	60601-160601-1-2CSA 22.2 #601-1

Table II - Summary of Device Characteristics

Conclusion

Independent, 3rd party electrical safety testing, adherence to U.S. FDA design control guidance, as well as thorough inhouse, 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.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

American Optisurgical, Inc. % Mr. David Salzberg Director of Regulatory Affairs 25501 Arctic Ocean Lake Forest, California 92630

AUG 2 7 2010

Re: K101561

Trade/Device Name: TX1 Tissue Removal System Regulatory Class: Unclassified Product Code: LFL, GEI Dated: June 02, 2010 Received: June 04, 2010

Dear Mr. Salzberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. David Salzberg

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): V

Device Name: TX1 Tissue Removal System

Indications for Use: 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Neil R. Ogden
Brimm, Siwell

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101561

Page 4-1

Regulation Number and Section

N/A