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Fragmentation, emulsification and aspiration of soft tissue in the neurosurgery field.

The DISSECTRON is an ultrasonically vibrating hand-held surgical aspirator designed to precisely fragment and emulsify unwanted neurosurgical tissue, layer by layer, with preservation of major blood vessels, nerves, and elastic fibers. The DISSECTRON's selective effect on tissue is the result of three combined factors: Ultrasonic fragmentation, Irrigation, and, Suction. The DISSECTRON's principle of operation is tissular fragmentation which is achieved through uitrasonic longitudinal vibrations at an oscillation amplitude varying from 120 to 300um, at an operating frequency comprised between 23 and 35 kHz at the tip of the handpiece. The ultrasonic power is transmitted via a piezoelectric transducer, housed in the handpiece, which extends into a titanium sonotrode which is in direct contact with the tissue. It is possible to precisely dissect tissue with less surrounding tissue invasion and blood loss with DISSECTRON. Simultaneous irrigation is provided to the distal end of the tip. Sterile saline is routed from the drip holder to the control unit to the tip of the electrostrictive handpiece. A vacuum pump aspirates emulsified tissue in the pressure range of 650 hPa. Irrigating fluid and fragmented tissue particles are continuously aspirated through the distal end of the hollow titanium sonotrode (tip) and transported, via disposable tubing, to a collection bottle ("receptacle"). The DISSECTRON, a compact, portable, tabletop ultrasonic surgical aspirator installed in the surgical suite within the user's reach, consists of three primary components: the base console, the hand-piece unit, (with 2 sonotrode dedicated extensions, and, the control pedal (footswitch). The base console is controlled by a microprocessor and provides various indicators and controls designed to lead the operator through the sequential procedures needed for safe operation. Touch screen controls and displays provide the surgeon with a user friendly device. The lightweight electrostrictive handpiece is equipped with a titanium sonotrode, which acts as an ultrasonic transmitter, and is fitted with central suction and concentric irrigation. The foot pedal has two footswitches, a right switch, and a left switch, respectively, to control the Suction, Irrigation, and Ultrasound power.

This document is a 510(k) premarket notification for the "DISSECTRON" ultrasonic surgical aspirator. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is not present in this document.

Here's an analysis of the provided text in relation to your request:

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

This information is not present in the provided document. The document describes the device and its intended use, and then lists predicate devices to which it claims substantial equivalence. It does not define specific performance acceptance criteria (e.g., fragmentation rate, blood loss reduction percentages, or specific tissue selectivity metrics) nor does it report the DISSECTRON's performance against such criteria through a dedicated study.

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

This information is not present. The document does not describe a performance study with a test set. It relies on a comparison to predicate devices, implying that their established performance serves as the benchmark for substantial equivalence.

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)

This information is not present. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

This information is not present. No test set or adjudication method is described.

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 information is not present and not applicable. The DISSECTRON is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reading improvement with AI is irrelevant to this device.

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

This information is not present and not applicable. The DISSECTRON is a surgical device operated by a surgeon (human-in-the-loop). There is no "algorithm only" performance that would be separated from human operation in this context.

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

This information is not present. Since a dedicated performance study with a specified "ground truth" is not detailed, this information is absent. The basis for safety and effectiveness is largely substantial equivalence to legally marketed predicate devices, meaning the established safety and effectiveness of those devices serves as the de facto "ground truth" for the DISSECTRON, rather than a new de novo ground truth establishment.

8. The sample size for the training set

This information is not present. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

This information is not present. See point 8.

Summary of available information regarding substantiation (instead of an "acceptance criteria" study):

The document aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a novel study.

• Predicate Devices: The DISSECTRON is deemed substantially equivalent to:

  • Cooper Cavitron CUSA 200M (K864943)
  • Sharplan 4300/4310 (K883091)
  • Clinical Technology BOVIE (K855138A)

• Basis for Substantial Equivalence:

  • Technical Characteristics: "The technical characteristics are almost identical to those of Cooper Cavitron CUSA 200 M, the Sharplan 4300/4310, and the Clinical Technology BOVIE previously cleared predicate devices." (Page 2)
  • Differences: Differences in technical specifications, materials, physical appearance, and control systems "do not affect the relative safety or effectiveness of the DISSECTRON device." (Page 2)
  • Intended Use: The intended use for the DISSECTRON is "for the successful fragmentation, emulsification and aspiration of soft tissue of various extirpation of any tumor in the central nervous system," which is consistent with the predicate devices. (Page 2) Specific indications are listed for neurosurgery, including various types of brain and spinal tumors. (Page 2)
  • Exclusions: It is explicitly not intended for cardiac surgery, suction lipectomy, or orthopedics. (Page 3)

In essence, the "study" proving the device meets criteria is implicitly the regulatory review process that determined its substantial equivalence to already cleared devices based on a comparison of device specifications and intended use. The FDA letter confirms this determination, allowing the device to be marketed.

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The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251.

Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field.

The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity.

Actuation mechanisms of the above systems is the same as the USU based as the following:

The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue.

The smashed tissue is taken out by the suction space between the probe and sheath of hand piece.

The Olympus USU mainly is used in microscopic surgery.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System (USU) submitted in 1996. The device is for smashing and aspirating diseased tissues in neurosurgery.

Based on the provided text, a conventional acceptance criteria and study to prove the device meets these criteria as would be expected for a diagnostic AI device or similar classification, is not detailed. The document focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis based on the information provided, highlighting the absence of typical acceptance criteria and study details for an AI-like device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The 510(k) summary does not set forth specific performance metrics or thresholds that the Olympus USU must achieve. Instead, it argues that the device is "substantially equivalent" to already-marketed predicate devices. This means its safety and effectiveness are established by demonstrating that it has the same intended use and similar technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Test Set Sample Size: Not applicable/Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not specified.

Explanation: The document does not describe a performance study with a test set of data (e.g., patient cases, images) to evaluate the device's accuracy or efficacy. The "study" described is a comparison against predicate devices, not an independent clinical trial using a defined test population.

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/Not specified.
• Qualifications of Experts: Not applicable/Not specified.

Explanation: Since there isn't a stated test set or a process for establishing ground truth for performance evaluation in the typical sense, there's no mention of experts being used for this purpose.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable/Not specified.

Explanation: As there's no test set described for performance evaluation, adjudication methods are not relevant to this 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:

• MRMC Study: No.
• Effect Size: Not applicable.

Explanation: This device is an ultrasonic surgical system, not an AI diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this submission.

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

• Standalone Performance Study: No.
• Explanation: This device is a surgical instrument operated by a human, not an autonomous algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not applicable/Not specified.
• Explanation: The concept of "ground truth" for evaluating performance metrics of a diagnostic or AI device is not applied in this submission. The "truth" here relates to the established safety and effectiveness of the predicate devices based on their prior clearance and historical use.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable/Not specified.

Explanation: This device is not an AI or machine learning model that requires a training set.

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

• Method for Establishing Ground Truth: Not applicable/Not specified.

Explanation: As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The acceptance criteria for the Olympus USU, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to predicate devices. The "study" (or rather, the regulatory argument) is a comparison to existing, legally marketed ultrasonic surgical aspirators.

The document asserts that:

• The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 (Predicate K#910696 and K#921251). Both are used for "smashing and aspirating disease tissues in the Neuro surgery field."
• The actuation mechanisms of the Olympus USU and the predicate devices are the same, involving "small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe... The tissue is smashed by the shock force... The smashed tissue is taken out by the suction space..."
• The Olympus USU is designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 601-1, 601-1-2, and CISPR 11).
• Compared to the predicate devices, the Olympus USU "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness."

Therefore, the proof that the device meets its "acceptance criteria" (i.e., is safe and effective) is established by asserting its fundamental technological and intended use equivalence to devices already cleared by the FDA, combined with adherence to relevant safety standards. No new clinical performance data from a specific study is presented to establish novel performance metrics.

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