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The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

The provided text is a 510(k) summary for the Olympus SonoSurg System. It focuses on demonstrating substantial equivalence to predicate devices and does not describe a study with acceptance criteria and a detailed performance evaluation in the way a clinical trial or algorithm validation study would.

Instead, the document explicitly states:

"Therefore clinical data is not necessary for its evaluation of safety and efficacy."

This means that the manufacturer did not conduct a new study to prove the device meets specific acceptance criteria through performance metrics. The basis for acceptance is stated as substantial equivalence to legally marketed predicate devices, implying that if the new device is sufficiently similar to devices already deemed safe and effective, it can also be considered safe and effective.

Therefore, many of the requested details about acceptance criteria and study parameters cannot be extracted from this document, as such a study was not performed.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices. This is demonstrated by showing the device does not incorporate "any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness."
• Reported Device Performance: Not reported in terms of specific clinical or technical performance metrics against a defined criterion. The document states that the device "has been designed and tested in compliance with voluntary safety standards," specifically IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-2, and that patient-contacting materials conform to ISO 10993-1. These are compliance reports, not performance results in the context of diagnostic accuracy or clinical outcomes.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth was established through expert review.

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 a surgical system, not an AI-assisted diagnostic or interpretative tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as no clinical study was performed.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available from the document:

• Basis for Acceptance: Substantial Equivalence to predicate devices (Olympus Ultrasonic Surgical System #K021962, CUSA Excel Ultrasonic Surgical Aspirator System #K981262, SONOPET UST-2001 Ultra Surgical Aspirator #K010309, and Ultrasonic Surgical System #K962952).
• Proof of Equivalence: The device's design, intended use, method of operation, and materials were compared to these predicate devices.
• Safety and Effectiveness Justification: The manufacturer asserts that there are no significant changes in the new device compared to predicate devices that would affect safety and effectiveness, and therefore, clinical data is not necessary. The device also complies with voluntary safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-2) and material standards (ISO 10993-1).

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This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment.

The Electrosurgical Unit XUES-41 produces the high frequency current waveform delivered to tissue via the electrosurgical accessories and electrodes. When the high frequency current is fed through tissue, it generates heat rises, causing changes from protein degeneration to desiccation and vaporization.

The provided text is a 510(k) summary for the OLYMPUS XUES-41 Electrosurgical Unit. It describes the device and its intended use, and importantly, it states that no clinical data was required or submitted to demonstrate the device meets acceptance criteria.

The basis for market clearance is that the XUES-41 is substantially equivalent to existing predicate devices (OLYMPUS UES-30 Electrosurgical UNIT and GYRUS Endourology System) and does not incorporate any significant changes that would affect safety and effectiveness.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study cannot be provided from this document as no such study was conducted or deemed necessary for this 510(k) submission.

Reason for Not Requiring Clinical Data:

The document explicitly states: "The subject XUES-41 is similar to the OLYMPUS UES-30 Electrosurgical UNIT cleared in the previous 510(k) #K023767, Gyrus cleared in the previous 510(k) #990628. And when compared to the predicated devices listed above, the Olympus XUES-41 Electrosurgical UNIT does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore the clinical data is not necessary for its evaluation of safety and efficacy."

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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 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.

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These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The regulatory filing provided (K023984) is a 510(k) premarket notification for Olympus Bronchoscopes (BF-40, 240, and 160 series). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.

Instead, the submission details a change in material for a component and argues that this change does not affect safety and effectiveness. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment, especially in the context of an AI device, is largely not present in this document.

However, I can extract the information that is implicitly part of a 510(k) substantial equivalence submission for a physical medical device like a bronchoscope:

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

The document does not provide a table of performance acceptance criteria or specific reported performance metrics for the reasons stated above. The "acceptance criterion" in a 510(k) for device modifications is primarily demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that the change does not introduce new questions of safety or efficacy.

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

This information is not directly applicable or provided in the context of this 510(k) submission. A material change typically involves engineering tests, biocompatibility testing (often in vitro or animal studies if new to medical devices), and potentially some form of simulated use or bench testing, rather than a clinical "test set" as one might see for an AI algorithm. No specific sample sizes for such tests are mentioned.

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. This type of information is relevant for studies relying on expert review for ground truth, which is not the case for this physical device modification.

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, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

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

Not applicable. For a physical device with a material change, "ground truth" typically relates to objective engineering specifications, material properties, and functionality tests, rather than clinical diagnostic agreement.

8. The sample size for the training set

Not applicable, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

Summary of Study (as per 510(k) for this device):

The "study" or evidence provided in this particular 510(k) is the assertion that the difference between the predicate devices and subject devices is only a change in material of the Biopsy Port, and that this change in material would not affect safety and effectiveness of the device. This is the core of the substantial equivalence argument.

While the document K023984 references "clinical data" in other sections, the publicly accessible portions of this specific 510(k) summary do not detail specific clinical studies for these devices beyond stating their intended use and comparing them to a predicate device when a material change is involved. For a material change, the supporting evidence would typically include:

• Material characterization: Data showing the physical and chemical properties of the new material.
• Biocompatibility testing: According to ISO 10993 or similar standards, to ensure the new material is safe for patient contact.
• Bench testing: To demonstrate that mechanical performance (e.g., flexibility, strength, torqueability, fluid paths) of the bronchoscope with the new biopsy port material is equivalent to or better than the predicate.
• Sterilization validation: Ensuring the new material can withstand the validated sterilization process without degradation.

The 510(k) process focuses on demonstrating substantial equivalence, often through a combination of engineering analysis, bench testing, and sometimes non-clinical or limited clinical data, rather than a full-scale clinical trial with specific performance acceptance criteria like those expected for novel technologies or AI.

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This instrument has been designed to be used with the ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle:

1. The NA-200H is provided pre-assembled, sterile single use disposable.
2. The NA-200H includes a sterile single use disposable syringe for aspiration.
   The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.

The provided document is a 510(k) summary for a medical device called the "DISPOSABLE ASPIRATION NEEDLE NA-200H." It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, this document does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, expert involvement, or adjudication methods.

The document primarily focuses on:

• Identifying the applicant and contact persons.
• Classifying the device.
• Establishing substantial equivalence to existing legally marketed devices (predicates).
• Describing minor modifications from the predicate device (pre-assembled, sterile, single-use, includes a sterile syringe).
• Stating the intended use.
• Concluding that the changes do not affect safety or effectiveness compared to the predicate.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present in the 510(k) summary. Such details would typically be found in a separate performance testing report or a more detailed technical submission, which is not included here.

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This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

This document describes the UES-30 Electrosurgical Unit, a Class II medical device, for which a 510(k) premarket notification was submitted. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for premarket clearance and focuses on substantial equivalence to a predicate device.

Therefore, the requested information (points 1-9) cannot be extracted from the provided text as it is not present.

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Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.

This instrument has been designed to be used with an Olympus endoscope to collect tissue within the upper and lower digestive tract and to extract the tissue sample through the biopsy forceps with suction.

The Olympus Biopsy Forceps XBO1-824-18/19/20 are composed with three major components as follows:

1. Biopsv Forceps (XBO1-824-18/19/20)
   The mechanism of subject device for collecting blopsied tissue is that biopsled tissue is caught onto Specimen trap by injected water through the biopsy forceps and it is possible to collect 5 samples continually.
2. Suction Tube (XBO1-824-18C)
   This device is for connecting the thumb ring valve to the suction source.
3. Specimen Trap (XBO1-824-18D)
   The Specimen Trap has a fitter for the specimen to be aspirated through the Aspiration Lumen, which can be attached onto the proximal section of the Biopsy Forceps. The Specimen Trap is comprised with five independent filters, which are arrayed serially. After it catches the specimen, the filter that holds the specimen, is extruded from the proximal handle of the Biopsy Forceps, and snapped off into an individual section. To avoid unexpected breakage of the Trap, the Trap Support guides the sections of the Traps. When the section of the Specimen Trap is inserted into the proximal handle, it will make a "click" sound, and the first Trap will be centered at the axis of the Aspiration automatically.

This FDA 510(k) summary for the Olympus XBO1-824-18/19/20 Biopsy Forceps does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a premarket notification for substantial equivalence, meaning the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, and thus does not require submission of clinical data. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not present in this document.

Here's why each point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific performance criteria through a study.
2. Sample sized used for the test set and the data provenance: No test set or associated data is described, as clinical data was not required for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is detailed.
4. Adjudication method for the test set: Not applicable, as no test set requiring adjudication 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: Not applicable. This device is a biopsy forceps, not an AI-powered diagnostic tool, and no MRMC study or AI-assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical instrument, not an algorithm.
7. The type of ground truth used: Not applicable, as no ground truth is described.
8. The sample size for the training set: Not applicable, as no training set or machine learning components are part of this device.
9. How the ground truth for the training set was established: Not applicable, as no training set or ground truth establishment is detailed.

The document explicitly states:

• "Compared to the predicate devices, 'Biopsy Forceps XBO1-824-18/19/20' does not incorporate any significant changes in intended use, methods of operations, materials, or design that could affect the safety and effectiveness." (Section F: Reason for not requiring clinical data)

This statement is the core of their 510(k) submission and explains why detailed performance studies with acceptance criteria are not included in this particular document.

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This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.

Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (Spray Catheter PW-6C-1), which primarily addresses substantial equivalence to a predicate device for market clearance. It does not include specific performance studies, statistical analyses, or details on ground truth establishment for a test set.

Therefore, I cannot populate the requested table or provide details for points 1-9 based on the given text.

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The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.

This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source.

This 510(k) summary (K011869) for the XENF-DP Rhino-Laryngofiberscope does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device (predicate device) and therefore does not require new clinical studies to prove safety and effectiveness.

Here's why and what information is missing:

• Reason for not requiring clinical data: The document explicitly states under section "G. Reason for not requiring clinical data": "When compared to the predicate devices, "XENF-DP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Observation within nasal and nasopharyngeal lumen has been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of its safety and efficacy."

Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary. The submission focuses on device design, materials, intended use, and technological characteristics, and compares them to predicate devices to establish substantial equivalence, rather than providing data from a new study against acceptance criteria.

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