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The EVIS Bronchofibervideoscope Olympus BF type XP160F has 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 subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

This document describes the Olympus EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F. The information provided heavily relies on a comparison to predicate devices for demonstrating substantial equivalence rather than explicit acceptance criteria with performance metrics from a dedicated study.

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

Since no explicit "acceptance criteria" are detailed as performance benchmarks, the substantial equivalence report implies that the device's performance is acceptable if it is equivalent to or better than the predicate devices for key characteristics. The "reported device performance" in this context refers to the specified characteristics of the subject device itself.

Study Information (Based on Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to existing legally marketed devices, rather than a dedicated clinical or performance study with acceptance criteria and corresponding results. The fundamental argument is that the subject device (BF type XP160F) is "basically identical" to the predicate device (BF-XP40) except for the control section and CCD, which are equivalent to the BF-160. Therefore, the "study" is a comparison of specifications and intended use.

1. Sample size used for the test set and data provenance:

   • N/A. No formal "test set" in the sense of patient or image data was used for performance validation against acceptance criteria. The evaluation is based on comparing device specifications.
   • The "data provenance" concerning the predicate devices' performance would be their approval through previous 510(k) submissions, demonstrating their safety and effectiveness.

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

   • N/A. No ground truth was established by experts for a test set in this 510(k) submission. The FDA reviews the provided technical specifications and comparisons to predicate devices.

3. Adjudication method for the test set:

   • N/A. No adjudication method was used as there was no test set requiring expert interpretation or consensus.

4. 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:

   • No. This device is a bronchoscope, a medical imaging and interventional tool. It is not an AI-powered diagnostic or assistive device, so an MRMC study is not applicable.

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

   • No. This device is an instrument operated by a human, not a standalone algorithm.

6. The type of ground truth used:

   • The "ground truth" implicitly used is the established safety and effectiveness of the legally marketed predicate devices based on their demonstrated performance and compliance with relevant standards. The subject device claims equivalence by maintaining similar or improved specifications.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this device.

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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 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.

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This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, display monitor, strobe light source specified by OLYMPUS, and ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy.

The subject device, the VISERA Rhino-Larvngovideoscope Olympus ENF type V is identical to the predicate device cleared in #K021073. This premarket notification is submitted to expand the intended use to add compatibility with strobe light sources specified by Olympus and change the applications from the nasal and nasopharyngeal lumens and airway and airway anatomy. Olympus specifies the Light Source Model 9100 B and 9100 C (#K921184) manufactured by Kay Elemetrics corp., for endoscopic diagnosis using the strobe light source.

The provided document describes a 510(k) submission for the "VISERA Rhino-Laryngovideoscope Olympus ENF Type V". This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance data against those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the given text.

The document states:
"When compared to the predicate device, the ENF-V does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for evaluation of safety and efficacy."

This indicates that the submission relies on the established safety and effectiveness of the predicate device and does not present new performance data from a specific study designed to meet new acceptance criteria. The device's compliance is primarily demonstrated through meeting voluntary safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18) and ISO 10993-1 for materials, rather than a clinical performance study with the metrics you've requested.

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This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney. Subject device may be used with three different Light source as follow, · A rechargeable powered Miniature Light source, or, · A battery powered Miniature Light source as predicate device, XENF-DP, or, · Light guide cable as predicate device, XENF-DP. In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.

The provided text is a 510(k) summary for the Olympus XCYF-TP3 Cystofiberscope/Nephrofiberscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria as would be found in a clinical trial report for a novel device. As such, the information you've requested regarding acceptance criteria and performance studies is not explicitly detailed in the provided document in the format you expect for a new, AI-enabled medical device.

However, I can extract information related to the demonstration of substantial equivalence, which is the core of this 510(k) submission.

Here's an interpretation based on the provided text, addressing your questions where possible:

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

The document does not provide a table of acceptance criteria and reported device performance in the form of specific quantitative metrics for sensitivity, specificity, accuracy, etc., as would be seen for an AI-enabled diagnostic device. Instead, the "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it's shown to be equivalent in terms of intended use, technological characteristics, and safety and effectiveness.

Here's how we can frame it based on the document:

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

The document states, "Therefore, the clinical data is not necessary for its evaluation of safety and efficacy." This indicates that no dedicated clinical test set or study was required or performed to demonstrate performance for this 510(k) submission, as substantial equivalence was established through technical and design comparisons to the predicate device.

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)

Since no separate clinical data or test set was generated for this 510(k), no experts were used to establish ground truth in the context of a new performance study. The "ground truth" for substantial equivalence rests on the predicate device's established safety and effectiveness.

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

As no specific test set was generated or analyzed for performance, no adjudication method was applied.

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

No MRMC study was conducted, nor is this device an AI-assisted diagnostic tool. It is a traditional endoscope.

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

Not applicable, as this is a physical medical device (an endoscope), not a standalone algorithm.

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

The "ground truth" for this 510(k) approval rests on the established safety and effectiveness of the legally marketed predicate device (Olympus XCYF-1T3). This implies that the predicate device's performance was previously demonstrated or accepted, likely through a combination of design validation, materials testing, and potentially prior clinical use or previous 510(k) submissions that established its safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is an endoscope, not an AI model, and therefore does not have a "training set" in the machine learning sense.

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

Not applicable. See point 8.

In summary, the provided document is a 510(k) notification for a physical medical device (an endoscope), not an AI/ML-powered diagnostic tool. Therefore, it focuses on demonstrating substantial equivalence to a predicate device through technical comparisons, rather than presenting a performance study with acceptance criteria, test sets, or ground truth establishment as would be done for a novel, data-driven device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esophageal(non-cardiac) Other 1) Gastrointestinal tract and the surrounding organs

These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery. These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.

The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive clinical studies with acceptance criteria and specific performance metrics in the way a PMA or a de novo submission would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted or inferred:

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

• Acceptance Criteria: Not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly are that the device performs similarly to the predicate device and meets safety standards.
• Reported Device Performance: Not reported in terms of quantitative clinical performance. The document focuses on demonstrating that the technological characteristics and intended use are equivalent to the predicate.

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

• Not Available. The document does not describe a clinical test set or patient data. The evaluation primarily relies on technical specifications and comparisons to existing devices.

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 / Not Available. There is no mention of a test set requiring expert ground truth establishment for clinical performance evaluation. The review is focused on engineering and regulatory equivalence.

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

• Not Applicable / Not Available. 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

• Not Applicable. This device is an ultrasonic gastrovideoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.

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

• Not Applicable. This is a hardware medical device (endoscope), not a standalone algorithm.

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

• Not Applicable / Not Available. As no clinical performance study involving a test set is detailed, no ground truth type is specified. The "ground truth" for this submission is regulatory compliance and substantial equivalence to predicate devices, which is demonstrated through technical standards compliance and comparative analysis of design and intended use.

8. The sample size for the training set

• Not Applicable / Not Available. 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 / Not Available. See point 8.

Summary of the Study:

The "study" presented is a 510(k) premarket notification which aims to demonstrate that the Ultrasonic Gastrovideoscope OLYMPUS GF Type UC160P-AT8 and UCT160-AT8 are substantially equivalent to legally marketed predicate devices. This involves comparing the new device's intended use, technological characteristics, and safety to existing devices.

The evidence provided includes:

• Comparison of Intended Use: The intended use (Trans-esophageal (non-cardiac) and for the gastrointestinal tract and surrounding organs) is stated to be consistent with predicate devices. The "Diagnostic Ultrasound Indications for Use Form" lists specific modes of operation (B, M, PWD, Color Doppler, Amplitude Doppler, Combined) for various clinical applications, noting which are "new" (N) for this specific device but are established modes generally.
• Comparison of Technological Characteristics: The document states the device "operate identically to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
• Compliance with Standards: The device is designed to comply with several IEC and CISPR standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11).
• Biocompatibility Testing: For a new patient-contacting material in the distal tip, biocompatibility tests were conducted, concluding the material is safe.

The "study" is not a clinical trial in the traditional sense designed to quantify diagnostic performance metrics. Instead, it's a regulatory submission affirming that the device design, materials, and function align with pre-existing, legally marketed devices.

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-Heat scissors generator set
The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.

-Heat scissors handpiece (XRF-940-M)
The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.

The Heat scissors system has been designed to cut and coagulate tissue for general (open) abdominal surgery. This system consists of the Heat scissors generator, Heat scissors handpiece and foot switch. This system uses direct thermal energy and simultaneous pressure to cut and coagulate tissue. The thermal energy is generated at the Heat-generating section of the blade, on the Heat scissors handpiece. It is conveyed via a non-stick coating on the blade to the tissue.

This 510(k) summary for the Olympus Heat scissors generator set and Heat scissors handpiece does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.

The document states: "When compared to the predicate devices, 'Heat scissors system' does not incorporate any significant difference for safety and efficacy to the predicate devices. Therefore, clinical data is not necessary for its evaluation of its safety and efficacy." This explicitly indicates that no clinical study was performed to establish new acceptance criteria or demonstrate performance against such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. This means that Olympus is claiming their Heat Scissors system is as safe and effective as existing legally marketed devices, rather than providing new performance metrics from a dedicated study.

Here's what can be extracted from the document regarding the device's design and testing, which are not the same as acceptance criteria and a study proving performance against them in the clinical sense:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in this document. The "acceptance criteria" here are implicitly linked to meeting the safety and efficacy profiles of the predicate devices.
• Reported Device Performance: Not reported in terms of specific clinical or measured performance metrics. The document instead states that the "Heat scissors system" has been designed, manufactured, and tested in compliance with voluntary safety standards IEC 60601-1 and IEC60601-1-2. It also notes that biocompatibility test reports show materials comply with ISO 10993-1. These are compliance statements, not performance metrics.

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

• Not applicable as no clinical or comparative performance study with a test set is described. The tests mentioned (IEC standards, biocompatibility) are likely bench or material tests, not clinical performance tests on humans.

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 is described.

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

• Not applicable. No 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

• Not applicable. This device is a surgical cutting and coagulation tool, not an AI-assisted diagnostic tool or system that would involve human readers.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. No clinical ground truth is described as being established for a performance study.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not an AI/ML algorithm that would have a training set.

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

• Not applicable. No training set or ground truth for it is described.

In summary: The provided 510(k) summary for the Olympus Heat Scissors system does not describe a study to prove acceptance criteria in the way envisioned by the prompt. It focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and biocompatibility, negating the need for new clinical performance data.

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This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating) including:

• Hemostasis of superficial bleeding
• Treatment of benign tumors like papillomatosis, granulomas, polyps, lipomas and hemangiomas in the trachea and bronchi
• Recanalization of malignant stenoses
• Treatment of Cicatricial stenoses of the respiratory tract

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating. Recommended endoscopes for this instrument are Olympus's series BF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instrument's instruction manual. The PSD-20 unit offers Monopolar output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode. (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

The provided text describes the Olympus PSD-20 Electrosurgical System and its associated accessories, a device for bronchial endoscopic treatment. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would typically be described for AI/ML-driven devices (e.g., sensitivity, specificity, AUC).

This document is a 510(k) summary for a medical device that generates electrical power for electrosurgical accessories, rather than a diagnostic or AI-powered device that interprets data or makes diagnoses. Therefore, the questions about sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided in this 510(k) submission.

The "acceptance criteria" mentioned in the document relate to compliance with voluntary standards for electrosurgical units. The "study" proving acceptance is essentially the design and testing demonstrating compliance with these electrical and safety standards.

Here's an attempt to answer the request based only on the provided text, acknowledging the limitations for an AI/ML context:

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 a submission for an electrosurgical unit, not a diagnostic or AI device with a "test set" in the conventional sense for performance evaluation. Compliance is shown through design adherence to standards and safety features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for performance metrics (sensitivity, specificity) is not relevant for this type of device submission.

4. Adjudication method 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 not an AI/ML-driven diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for performance metrics. The "ground truth" for this device's acceptance is its compliance with established electrical, safety, and electromagnetic compatibility (EMC) standards.

8. The sample size for the training set
Not applicable. This device is not an AI/ML-driven device that undergoes "training."

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

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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus, including:

• Abnormal uterine bleeding
• Evaluation of abnormal hysterosalpingogram
• Evaluation of abnormal ultrasound image
• Infertility and pregnancy wastage
• Pelvic pain

This subject device is videoscope used for diagnosis within the uterus. New type of CCD is lead to be more easier observation and diagnosis. In HYF-V, a light guide connector and a video connector are separated each other. The light guide connector is to connect with a light source and the video connector is with a video system center.

This 510(k) summary (K022445) is for a Hysteroscope, a rigid or flexible endoscope used for diagnostic and therapeutic procedures within the uterus. The document provided does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in your request.

The information in the provided document is mostly administrative and focuses on establishing substantial equivalence to previously cleared devices, rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown based on the information provided, and where information is missing:

Reported Device Performance and Acceptance Criteria

(1) A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This type of information is usually associated with AI/CADe (Computer-Aided Detection) devices or novel technologies where quantifiable performance is a key aspect of demonstrating safety and effectiveness.

For the VISERA Hysterovideoscope, the FDA cleared it based on substantial equivalence to existing predicate devices (BF-240 and HYF-P Flexible hysterofiberscope). This means the manufacturer argued that the new device has "no significant change for its safety and efficacy" compared to the predicate device, and therefore detailed performance acceptance criteria in the format you described were not required or presented.

The summary states: "Compare to the predicate device, this subject device "HYF-V" does not incorporate any significant change for its safety and efficacy to the predicate device. Observation within uterus has been spread, therefore clinical date is not necessary for its evaluation of safety and efficacy."

This explicitly states that clinical data (which would include performance studies against acceptance criteria) was deemed not necessary because the device's technological characteristics and intended use are considered similar to already cleared devices.

Study Design Information (Not Applicable/Missing for this submission)

The following points refer to details typically found in the clinical testing of devices, especially AI/CADe. Since this 510(k) was based on substantial equivalence without clinical data, these details are not present in the provided document.

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

• Not Applicable / Not Provided. No test set was used for a performance study.

(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 / Not Provided.

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

• Not Applicable / Not Provided.

(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 is not an AI/CADe device.

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

• Not Applicable / Not Provided. This is not an AI/CADe device.

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

• Not Applicable / Not Provided.

(8) The sample size for the training set

• Not Applicable / Not Provided. This is not a machine learning device.

(9) How the ground truth for the training set was established

• Not Applicable / Not Provided.

Summary of K022445 Content Regarding Performance/Testing:

The provided 510(k) summary for the VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V focuses on:

• Device Description: A videoscope for diagnosis within the uterus, featuring a new CCD for easier observation. It has separate light guide and video connectors.
• Intended Use: Endoscopic diagnosis within the uterus for conditions like abnormal uterine bleeding, evaluation of abnormal hysterosalpingogram/ultrasound, infertility, and pelvic pain.
• Technological Characteristics: States it "does not have special technological characteristics compared to the existence videoscope such as GI tract bronchial application."
• Safety Standards: Complies with IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
• Materials: No new patient-contacting materials; all are cleared by previous 510(k)s and confirmed with ISO 10993-1.
• Substantial Equivalence: Claims substantial equivalence to Olympus BF-240 and Olympus HYF-P Flexible hysterofiberscope. The core argument for clearance is that it does not present significant changes in safety or efficacy compared to these predicate devices, making clinical data "not necessary."

This type of 510(k) demonstrates safety and effectiveness largely through comparison to predicate devices, rather than through extensive new clinical performance studies with specific acceptance criteria.

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The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

Do not use these instruments for any purpose other than their intended uses.

This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,

XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18.

There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.

The provided document is a 510(k) summary for the Olympus XTJF-160AF Duodenovideoscope. It discusses the device's substantial equivalence to previously marketed devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on:

1. Intended Use: The intended use of the XTJF-160AF is identical to previously cleared devices (TJF-140R and JF-V10).
2. Mechanical Structure: The variable stiffness mechanism is identical to another predicate device (EVIS EXERA Colonovideoendoscopes), which has already been deemed safe.
3. Materials: No new patient-contacting materials are used, and all materials have been cleared by previous 510(k)s and confirmed with ISO 10993-1.
4. Safety Standards: The device complies with IEC60601-1, IEC60601-1-2, and IEC60601-2-18.

Therefore, I cannot populate the requested table or answer the specific questions about studying device performance as this information is not present in the provided text.

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This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating) including:

• Hemostasis of superficial bleeding
• Treatment of bladder tumors
• Treatment of stenosis inside urinary tract.

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating). Recommended endoscopes for this instrument are Olympus's series CYF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instruction manual. The PSD-20 unit offers Monopolar, output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode, (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

This document is a 510(k) summary for the Olympus PSD-20 Electrosurgical System. It outlines the safety and effectiveness of the device by comparing it to predicate devices. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance metrics.

Specifically, the provided text does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or number of experts for ground truth.
• Adjudication method, MRMC comparative effectiveness study results, or standalone algorithm performance.
• The type of ground truth used, sample size for a training set, or how training set ground truth was established.

Instead, the document focuses on:

• Device Identification: Sponsor, contact, common name, device name, classification.
• Predicate Devices: Lists two Olympus electrosurgical units (K970797 and K970184) as substantially equivalent.
• Device Description:
  • Summary: Describes its use with Olympus accessories, endoscopes (CYF series), and electrosurgical instruments (snare, hot biopsy forceps) for flexible cystoscopic treatment (cutting and coagulating). Mentions Monopolar output, 5 Cut modes, 1 Coagulation mode, and safety features.
  • Design: States compliance with voluntary standards IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2 (EMC).
  • Materials: Notes no patient-contacting materials in the PSD-20 itself, and ancillary equipment with patient-contacting materials have no new materials.
  • Technology: Describes it as providing electrical power to accessories via high-frequency electrical current for endoscopic urological treatment, with no special technology.
• Indication for Use: Flexible cystoscopic treatment (cutting and coagulating) including hemostasis of superficial bleeding, treatment of bladder tumors, and treatment of stenosis inside the urinary tract.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices and clearance to market.

In summary, this document is a regulatory submission for device clearance based on substantial equivalence, not a performance study proving specific acceptance criteria related to an AI or diagnostic algorithm.

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