Search Results

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.

Ask a specific question about this device

The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.

The Vizual™ Phacoemulsification system is a complete anterior segment surgical system, offering Irrigation, Phaco or Ultrasonic (U/S), Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation modes of operation. The device can be operated as a standalone unit, or connected to an optional cart with electric I/V pole where bottle height can be controlled by the software. The Vizual™ Phacoemulsification System includes the Phaco unit, U/S handpiece, tubing cartridge, and foot pedal. The device has been designed to work with commercially available (and 510k cleared) components and accessories including Phaco tips and sleeves, vit cutters, cautery pencils, and cautery forceps. The Vizual™ Phacoemulsification System utilizes a non-invasive vacuum sensing system including an external tubing cartridge that vents to the bottle versus air, thus minimizing the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, and can be easily installed or removed in a single step. The Vizual™ Phacoemulsification System uses a LCD touch panel interface to allow access to all modes of operation. The system software allows for storing up to twenty-four different user profiles.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Vizual™ Phacoemulsification System, Model 551:

This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device, rather than specific performance metrics like those for AI algorithms. The "study" proving this substantial equivalence usually involves comparing the new device's technological characteristics and intended use to those of a legally marketed predicate device.

The provided document does not describe a study involving AI or machine learning algorithms. Therefore, questions related to AI-specific performance metrics (such as sample sizes for test/training sets, ground truth establishment methods, expert adjudication, or MRMC studies) are not applicable.

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the primary "acceptance criterion" is demonstrable substantial equivalence to a predicate device. The device performance is assessed by comparing its characteristics to the predicate.

Regarding the Study:

The "study" to prove the device meets the acceptance criteria is a 510(k) substantial equivalence comparison. This is a regulatory pathway, not a clinical trial or performance study in the AI sense. The manufacturer compares their new device (Vizual™ Phacoemulsification System) to a legally marketed predicate device (K020527, Horizon Phacoemulsification System) to demonstrate that it is equally safe and effective.

Here's why the subsequent questions are not applicable to the provided document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. This device is a surgical instrument (phacoemulsification system), not an AI algorithm that processes data. No "test set" of images or patient data is mentioned in this summary for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. There is no "test set" or diagnostic ground truth being established as this is not an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No test set or human adjudication process is described for this type of device submission.

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

   • Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable. There is no "ground truth" in the AI sense required for this type of device. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.

8. The sample size for the training set

   • Not applicable. This is not an AI algorithm requiring a training set.

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

   • Not applicable. There is no training set for this device.

Ask a specific question about this device

The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.

The Horizon Phacoemulsification System utilizes the same technology as the currently marketed predicate devices that employ ultrasonic energy to emulsify a cataractous lens and remove it from the eye. The intended use and performance specifications are also comparable to the predicate devices. The subject of this 510(k) is the Horizon Phacoemulsification System's design configuration of a non-invasive vacuum sensing system that maintains sterile fluids, and the unit's software controlled user interface.

The Horizon Phacoemulsification System utilizes an external tubing cartridge venting to the bottle versus air, to minimize the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, easily removed/ replaced at the end of the case. The Horizon system uses a software-controlled interface that assists the user in not only system set up but in all modes of operation during surgery. The advanced microprocessors allow the surgeon to program surgical parameters for up to six different users by an LCD touch panel display.

The Horizon Phacoemulsification System has similar operation modes as the predicate devices, i.e. Ultrasonic (U/S), Irrigation, Irrigation/ Aspiration (I/A), Vitrectomy, and Diathermy or Coagulation modes utilized in cataract extraction. The component parts of the Horizon Phacoemulsification System include the U/S handpiece, the tubing cartridge, and the footswitch as these items can only be used with this system. The Cautery, Vitrectomy, and Irrigation/ Aspiration devices are universal-type handpieces that are considered additional accessories to the Horizon system.

The provided text describes a 510(k) submission for the Horizon Phacoemulsification System. It does not include a study proving the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's an analysis based on the information provided, addressing your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense of a performance study with specific numerical acceptance criteria. The "acceptance criteria" here are implied by the demonstration of substantial equivalence to predicate devices, meaning the device must perform similarly to those already on the market. The reported performance is the assertion that its characteristics are the same or comparable, without new technological characteristics or performance specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No "test set" in the context of a clinical performance study was conducted. The assessment is based on a comparison of device characteristics against predicate devices.
• Data Provenance: The data provided is for the device's design and features, compared against existing predicate devices already on the market (K931354, K991852, K946054). This is a retrospective comparison of product specifications, not prospective data from a human trial. The country of origin for the data is implied to be the US, as it's an FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. "Ground truth" in the clinical sense was not established for a test set. This type of submission relies on the regulatory body (FDA) comparing the provided device characteristics with those of already cleared devices to determine substantial equivalence.
• Qualifications of Experts: The FDA reviewers are the "experts" in determining substantial equivalence based on regulatory guidelines and their understanding of medical devices. Their qualifications would involve scientific and regulatory expertise.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No formal adjudication of results from a test set was performed. The FDA's review process itself serves as the adjudication by the regulatory body.

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 device is a phacoemulsification system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No, not in the sense of an algorithm. This is a medical device (hardware and embedded software) for a surgical procedure. Its performance is inherent in its physical and operational characteristics, not a standalone algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed safe and effective because its characteristics and intended use are substantially equivalent to those predicates, which have already gone through the regulatory process to demonstrate their own safety and effectiveness. No new clinical outcomes data or pathology results were submitted as ground truth for this specific device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML product developed using a training set in the typical machine learning sense. The "training" for this device would be its engineering design, development, and testing processes to meet its specifications, drawing upon established engineering principles and data from similar devices.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As per point 8, there isn't a "training set" in the AI/ML context. The design and manufacturing of the device are based on established engineering and medical principles for phacoemulsification systems, which were validated through the prior regulatory clearance of its predicate devices.

Ask a specific question about this device