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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 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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The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery.

The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.

The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes and videoscopes) applicable for electrosurgery, light sources and ancillary equipment.

This document describes the Olympus PSD-20 Electrosurgical System, a medical device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text.

Based on the provided information, I can offer the following:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The 510(k) summary for the Olympus PSD-20 Electrosurgical System focuses on demonstrating substantial equivalence to a predicate device (Olympus PSD-10 Electrosurgical Unit K911904) rather than presenting specific acceptance criteria and performance data for the new device. The document indicates that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976.

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

Not available in the provided text. The document does not describe a test set or data provenance for a performance study.

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

Not available in the provided text. The document does not mention the establishment of ground truth by experts for a test set.

4. Adjudication Method for the Test Set

Not available in the provided text. No adjudication method is described as there is no mention of a test set requiring such a process.

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

Not applicable. This device is an electrosurgical system, not an imaging or diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study with AI assistance is not relevant to this type of device.

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

Not applicable. This device is an electrosurgical system, not an algorithmic diagnostic tool. It requires a trained physician for its operation, so a "standalone" algorithmic performance study without human involvement is not relevant.

7. Type of Ground Truth Used

Not available in the provided text. There is no mention of a performance study that would establish ground truth for the device's function in terms of diagnosing or interpreting medical conditions. The device performs cutting and coagulation.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device, not an AI algorithm that would require a training set.

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

Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.

Summary of Device and its Equivalence Basis:

The Olympus PSD-20 Electrosurgical System is intended for general and endoscopic electrosurgery (cutting and coagulation) in the gastrointestinal (GI) tract. The 510(k) submission successfully demonstrated that this device is substantially equivalent to the predicate device, Olympus PSD-10 Electrosurgical Unit (K911904). This substantial equivalence determination means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The focus of the 510(k) process is typically on comparing the new device's technological characteristics, indications for use, and performance data to those of the predicate device, rather than conducting new, extensive clinical trials with specific acceptance criteria as would be expected for novel, high-risk devices.

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