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1. Indications for Use of SonoSurg Trocar

This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall.

2. Indications for Use of SonoSurg G-2 Set

This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures.

This instrument may also be combined with the SonoSurg Irrigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system.

This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

The SonoSurg Trocar is an Ultrasonic trocar for endoscopic surgery which enable the puncture and cutting of the abdominal wall with tissue coagulation by means of ultrasonic vibration. SonoSurg Trocar is composed of two sections, the SonoSurg Trocar and the Olympus SonoSurg Generator SonoSurg-G2.

The SonoSurg Trocar is composed of a trocar transducer, dilator, valve, trocar tube, insertion sheath, probe, and Olympus SonoSurg Generator SonoSurg-G2, which provides ultrasonic vibration to the SonoSurg Trocar.

This document is a 510(k) Pre-market Notification for a medical device called the "SonoSurg Trocar." It's essentially a request to the FDA to market a new device by demonstrating its substantial equivalence to a device already legally on the market.

Crucially, this type of submission (510(k)) generally does NOT include new clinical studies or detailed performance data to establish acceptance criteria for the new device itself. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed "predicate device."

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this specific submission will be largely absent because it's inherent to the 510(k) pathway that such detailed, de novo clinical studies are typically not performed or required.

Here's how to address your request based on the provided document:

Acceptance Criteria and Study for SonoSurg Trocar (K042160)

This 510(k) submission for the SonoSurg Trocar does not present new acceptance criteria or a dedicated study to prove the device meets such criteria in the way you've outlined. Instead, the submission demonstrates "substantial equivalence" to a predicate device already on the market. The implied "acceptance criteria" here are that the new device performs comparably to the predicate device and does not raise new questions of safety or effectiveness.

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

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

• Not applicable. This submission did not involve a test set for clinical performance evaluation as part of a de novo study. The FDA determined substantial equivalence based on a comparison to the predicate device's established safety and effectiveness. The biocompatibility testing likely involved standard laboratory samples, not a clinical "test set" in the context of device performance.

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. No ground truth establishment by experts for a test set was described in this 510(k) summary.

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

• Not applicable. No adjudication method for a test set was 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

• Not applicable. This document describes a surgical instrument, not an AI-assisted diagnostic device. No MRMC study was performed or described.

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

• Not applicable. This device is a surgical instrument. "Standalone algorithm performance" is not relevant.

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

• Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate device (SonoSurg Trocar XT3900, K000095, and Olympus SonoSurg System, K021962/K031305/K031523/K031710). The submission argues that the new device is comparable to this established safe and effective predicate.

8. The sample size for the training set

• Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

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

• Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

Summary of the 510(k) Approach for the SonoSurg Trocar:

The core of this submission is the claim of "substantial equivalence" to existing predicate devices.

• Rationale for not requiring clinical data: "When compared to the predicate device, the SonoSurg Trocar 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."
• Demonstration of Equivalence:
  • Intended Use: The intended uses of the SonoSurg Trocar system are presented and are consistent with the predicate.
  • Technological Characteristics: The theory of operation is stated to be equivalent to the predicate device.
  • Design and Materials: Compliance with voluntary safety standards (IEC 60601 series) for the generator and biocompatibility testing for non-identical patient-contacting materials (ISO 10993-1) are referenced.
  • Predicate Device: Clearly identifies the Olympus SonoSurg Trocar XT3900 (K000095) and the Olympus SonoSurg System (multiple 510(k)s) as predicate devices.

In essence, the "study" for this device was a comparison against established, already-cleared devices, rather than a novel clinical trial with specific performance endpoints.

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The SonoSurg Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.

The subject SonoSurg is an ultrasonic surgical device designed to be used with Generator Irrigation Unit and Transducer and ultrasonic surgical instruments to dissect, fragment, enulsify and aspirate tissue in the neurosurgical field. This system consists of the SonoSurg Senerator (SonoSurg-G2 set), SonoSurg Imigation Unit (SonoSurg-IU), SonoSurg-Transducer(SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.

This submission is for a 510(k) premarket notification for the SonoSurg Ultrasonic Surgical System. The document does not describe a study to establish acceptance criteria or demonstrate device performance through clinical trials or specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

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

The provided documentation does not include a table of acceptance criteria or specific performance metrics with reported results for the SonoSurg Ultrasonic Surgical System. The demonstration of safety and effectiveness is primarily through substantial equivalence to predicate devices, supported by non-clinical tests for design and materials.

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

Not applicable. The submission relies on non-clinical tests and a comparison with predicate devices, rather than a test set with patient data.

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 in the conventional sense that would require expert-established ground truth.

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

Not applicable.

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 an ultrasonic surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is an ultrasonic surgical system, not an algorithm, and is intended for use with a human medical professional.

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

Not applicable. The evaluation is based on non-clinical tests and comparison to predicate devices, not on a ground truth derived from clinical data.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

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These instruments have been designed to be used with Olympus endoscopes to inject contrast media into the biliary or pancreatic tract. They can also be used for retrieval of biliary or pancreatic stones.

The subject device(s) is a balloon catheter that has a triple-lumen catheter and a multiple sizing balloon with pre-measured syringes, to be used in accordance with Intended use of the device. These functions ensure smoother passage of the guidewire and injection of the contrast media without removing the guidewire, and enable to inflate one balloon to 3 different sizes.

The provided document, K033333, is a 510(k) premarket notification for a medical device: the Single Use 3-Lumen Balloon Catheter, Models B-230Q-A and B-230Q-B.

This document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (B-5/B-7 series Balloon Catheter K962925) based on intended use, method of operation, materials, and design, and explicitly states that no significant changes that could affect safety or effectiveness were made.

Therefore, I cannot provide the requested information in the format specified because the document does not contain the necessary details about performance studies, sample sizes, ground truth establishment, or expert involvement.

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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.

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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.

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This instrument has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.

Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The instrument consists of the Drainage Tube, and Insertion Kit and Guidewire. The Drainage Tube is not intended to be permanently implanted in the patient. The drainage Tube is intended for short-term implantation.

This looks like a 510(k) premarket notification for a medical device called a "Pancreatic Drainage Tube." This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a clinical study report with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/CAD-like device is not applicable to this document.

Here's why and what information can be extracted:

• No AI, CAD, or similar device: The Pancreatic Drainage Tube is a physical medical instrument (a stent for drainage), not an artificial intelligence algorithm or computer-aided detection system.
• Substantial Equivalence: The primary goal of a 510(k) for this type of device is to show that it's as safe and effective as a previously cleared device. This typically involves comparisons of materials, design, intended use, and sometimes non-clinical (bench) testing, but not usually extensive clinical trials with performance metrics and ground truth establishment in the way an AI diagnostic device would.

Information Extracted from the Document (as relevant):

While I cannot provide the specific requested table and study details, I can tell you what this document does communicate about its clearance:

• Acceptance Criteria/Performance (Implied): The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of safety and effectiveness. The reported "performance" is that the device "does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness" when compared to the predicate device.
• Study Type: This is a premarket notification (510(k)) based on a comparison to predicate devices, not a clinical effectiveness study in the sense of an AI/CAD device.
• Ground Truth: For a physical device like this, "ground truth" relates to its physical properties, biocompatibility, and mechanical performance. The document states "Conclusions drawn from Non-clinical Tests" implying bench testing or material analyses were done, but no specific metrics are provided here.
• Training Set/Test Set/Experts/Adjudication/MRMC/Standalone Performance: These concepts are entirely irrelevant to a 510(k) for a physical medical instrument like a pancreatic drainage tube. There's no AI algorithm to train or test, no diagnostic interpretation to be adjudicated by experts, and no human-in-the-loop performance to measure.

Summary of Relevant Information from the Provided Text:

• Device Name: Pancreatic Drainage Tube
• Intended Use: Used with Olympus endoscopes for Endoscopic Pancreatic Drainage. Not intended for permanent implantation; intended for short-term implantation.
• Predicate Devices: Olympus PBD Stents #K933200 and Zimmon Endoscopic Pancreatic Stent (K900923 Wilson-Cook Medical, Inc.)
• Basis for Clearance: Substantial equivalence to predicate devices, indicating no significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness.
• Testing: Non-clinical tests were performed, but specific details or quantitative results are not provided in this summary. The summary only states that these tests support the conclusion of substantial equivalence.

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The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

Mucus Collection Probes, BC-401C and BC-402C, have been designed to be used with an Olympus endoscope to collect bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents. Single use.

This response is based on the provided text.

The information provided describes a 510(k) premarket notification for the Olympus Mucus Collection Probe BC-401C, BC-402C. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and a detailed study design as might be seen for novel devices. Therefore, much of the requested information (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not typically included or required in a 510(k) premarket notification for a device of this nature.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are provided in the document. The submission asserts substantial equivalence based on the intended use, method of operation, materials, and design being similar to the predicate device.

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

Not applicable. The document does not describe a clinical performance study with a test set. The review is based on a comparison to a predicate device, focusing on design, intended use, and operational similarities.

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

Not applicable, as no test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set:

Not applicable.

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

No MRMC study was performed or is mentioned in the provided text.

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

Not applicable, as this is a physical medical device (mucus collection probe), not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable, as no performance study requiring ground truth is described.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and there is no mention of an algorithm or training set.

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

Not applicable.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) submission is primarily a comparison to a predicate device. The key statement from the document is:

"When compared to the predicate device, the subject device does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."

This statement serves as the basis for FDA's determination of substantial equivalence, which is the "acceptance criteria" for a 510(k) clearance in this context. The detailed comparison table in section {1} highlights the similarities and minor differences (e.g., maximum diameter, brush diameter, fiber rod presence) between the subject devices (BC-401C/402C) and the predicate device (BC-14C/15C/16C). The argument is that these differences do not raise new questions of safety or effectiveness.

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