Search Results

These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit

The major components of this system are the generator, handpiece, and accessories. The generator supplies electrical energy for ultrasonic vibration of the handpiece (transducer). The ultrasonic vibration is transferred to the tip of probe. Soft body tissue is incised and coagulated through the ultrasonic energy delivered by the handpiece.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System SonoSurg, which is a premarket notification to the FDA to market a medical device. This type of submission is for proving substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for a novel device.

The relevant sections of the document explicitly state:

• G. REASON FOR NOT REQUIRING CLINICAL DATA: "When compared to the predicate device, the Ultrasonic Surgical System SonoSurg does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."

Instead of a study proving performance against acceptance criteria, the submission focuses on demonstrating:

• Substantial Equivalence: The primary "study" here is a comparison to predicate devices, showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
• Compliance with Voluntary Safety Standards: The document states, "The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000." These standards serve as the "acceptance criteria" for electrical safety and EMC, and the "study" is the testing performed to demonstrate compliance.

Given this, I cannot fill out the requested table and answer the study-related questions as if a clinical or performance study was conducted to prove specific accuracy or effectiveness metrics. The information is simply not present in a 510(k) summary for a substantially equivalent device that does not require clinical data.

I can, however, extract the information about the predicate devices for context:

Predicate Devices:

Summary of Device and Claim for Equivalence:

• Intended Use: These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit.
• Technological Characteristics: The mechanism of this system is that the electrical energy employed in the main unit is changed to mechanical energy by ultrasonic vibration. This is the same as the referenced Olympus predicate devices.
• Materials: All of the patient contacting materials used in the components of the "Olympus Ultrasonic Surgical System SonoSurg" are identical materials used in legally marketed Olympus devices.

The "study" proving acceptance criteria here is the demonstration of substantial equivalence to already cleared devices and compliance with relevant safety standards, not a new clinical performance study.

Ask a specific question about this device

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.

This medical device submission for the Olympus Ultrasonic Surgical System (K031523) does not contain acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML algorithm evaluation.

The provided documents describe a traditional medical device (an ultrasonic surgical system) and its substantial equivalence to predicate devices based on technological characteristics and intended use. The submission explicitly states:

"G. Reason for not requiring clinical data: When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

This indicates that the approval was based on a comparison to existing devices, not on a performance study against specific acceptance criteria for an AI/ML component.

Therefore, I cannot provide the requested information for an AI/ML study because it is not present in the provided text.

Ask a specific question about this device

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System. It's a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's design and technological characteristics but does not explicitly state specific acceptance criteria (e.g., performance thresholds of a certain metric). Instead, it focuses on demonstrating that the device meets safety standards and operates on the same principles as its predicate devices.

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

The document explicitly states: "When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

This means:

• Sample size for the test set: Not applicable, as no external test set or clinical study was conducted for this 510(k) submission.
• Data provenance: Not applicable.

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

Not applicable, as no clinical study or test set requiring expert ground truth was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study or test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not necessary due to substantial equivalence to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a surgical instrument system, not an AI algorithm. Its performance is inherent to its physical design, materials, and operating principle, which are compared to existing, cleared devices.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" in this context is the safety and efficacy established for the predicate devices through prior regulatory clearances and adherence to recognized safety standards. The new device demonstrates equivalence to this established performance.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

In summary:

This 510(k) submission for the Olympus Ultrasonic Surgical System relies on demonstrating substantial equivalence to already cleared predicate devices. The core argument is that the device has the same intended use, similar technological characteristics, and adheres to the same safety standards, with no significant changes to safety or efficacy. Therefore, no new clinical studies, test sets, or ground truth establishment (as would be typical for a novel diagnostic or AI device) were deemed necessary by the submitter and subsequently agreed upon by the FDA for clearance.

Ask a specific question about this device

The Olympus Ultrasonic System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general(open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

The provided document is a 510(k) summary for the Olympus Ultrasonic Surgical System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from extensive clinical studies with acceptance criteria in the manner typically seen for novel medical devices or software.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth procedures, and MRMC studies for device performance is largely not applicable in this context.

Here's why and what information can be extracted or inferred:

• No explicit acceptance criteria for device performance are listed. The submission relies on demonstrating that the device meets existing safety standards and has technological characteristics "the same as the Predicate Devices."
• No clinical study demonstrating the device meets acceptance criteria is presented. The document explicitly states: "When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."
• This is not an AI/Software as a Medical Device (SaMD) submission. Therefore, questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth establishment for AI) are irrelevant.

However, I can provide a table based on the safety standards the device complies with, which function as "acceptance criteria" for the device's design and manufacture.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study requiring a test set of data. The device's safety and efficacy are established through comparison to predicate devices and compliance with recognized consensus standards for design and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no test set requiring expert ground truth for device performance evaluation in this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was presented.

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 is not an AI/SaMD device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device and submission, "ground truth" relates to compliance with safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy or patient outcomes.

8. The sample size for the training set
Not applicable. This is not an AI/SaMD device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.

Ask a specific question about this device

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.

This 510(k) summary for the Olympus Ultrasonic Surgical System (K021962) explicitly states that clinical data was not required for its evaluation of safety and efficacy.

Therefore, the study that proves the device meets acceptance criteria, and many of the associated details you requested, are not provided in this document. The decision was based on a finding of "substantial equivalence" to predicate devices, implying that the new device does not incorporate any significant changes that would affect safety or efficacy when compared to existing, legally marketed devices.

Here's a breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document states: "When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

The "acceptance criteria" are implied to be the standards met by the predicate devices and the voluntary safety standards the new device complies with.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No clinical test set was used. The substantial equivalence determination was based on design, materials, and functional characteristics compared to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No clinical test set or ground truth established by experts was used.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set.

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/Not provided. This device is an ultrasonic surgical system, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable/Not provided. This is a surgical device, not an algorithm.

7. The type of ground truth used

Not applicable/Not provided. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the device's acceptable performance is its substantial equivalence to previously cleared devices and compliance with relevant safety standards.

8. The sample size for the training set

Not applicable/Not provided. No AI/machine learning model, therefore no training set.

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

Not applicable/Not provided. No AI/machine learning model, therefore no training set or ground truth for it.

In summary: The Olympus Ultrasonic Surgical System (K021962) received 510(k) clearance based on its substantial equivalence to existing predicate devices and adherence to recognized safety standards (IEC 60601 series). No specific clinical study or data related to acceptance criteria, test sets, or expert-established ground truth was required or performed for this premarket notification.

Ask a specific question about this device

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.

Ask a specific question about this device