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The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.

The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.

The provided document is a 510(k) Premarket Notification for a medical device called the "Mini PCNL-System" by TROKAMED GmbH. It details a comparison to a predicate device and non-clinical performance testing. The document does not contain information about acceptance criteria and device performance in the context of a clinical study, human-in-the-loop performance, or AI assistance.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of the physical characteristics, reprocessing, life expectancy, biocompatibility, and mechanical properties of the device components.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
• Sample size used for a test set (in a clinical context).
• Data provenance (country of origin, retrospective/prospective) for a clinical test set.
• Number of experts used or their qualifications for establishing ground truth in a clinical setting.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for a clinical study.
• Sample size for a training set (as this is not an AI/ML device).
• How ground truth for a training set was established (as this is not an AI/ML device).

The document is about demonstrating the safety and effectiveness of a surgical instrument (an endoscope accessory set) through engineering and biological testing, not a diagnostic or AI-powered device.

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The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.

This document is a 510(k) summary, which is a premarket notification submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It is not a detailed study report designed to present specific acceptance criteria and performance data for a novel device, nor an AI device. Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, and AI-specific metrics is not available in the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed performance metrics against those criteria in a tabular format as would be found in a study report. Instead, it relies on demonstrating compliance with recognized consensus standards and substantial equivalence to predicate devices.

For "Performance Data," the document states:
"The device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility."

This indicates that the "acceptance criteria" are compliance with these listed standards. The "reported device performance" is that the device "complies" with these standards.

2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device (morcellator), not an AI algorithm. The performance data refers to compliance with safety and compatibility standards, not a clinical test set with a specific sample size of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device, not an AI algorithm requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device, not an AI algorithm requiring adjudication for a 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. This is a medical device (morcellator), not an AI-assisted device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device, "ground truth" would be compliance with engineering and safety standards, and confirmation that its functional performance is similar to predicate devices, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set
Not applicable. This is a medical device (morcellator), not an AI algorithm that uses a training set.

9. How the ground truth for the training set was established
Not applicable. This is a medical device (morcellator), not an AI algorithm.

Summary based on the document:

The Trokamed Morcellator is a motorized unit for tissue morcellation during laparoscopic procedures. Its "acceptance criteria" appear to be compliance with established international standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and the Medical Device Directive 93/42/EEC, along with manufacturing under ISO 13485. The "study" for these criteria is the testing performed to demonstrate compliance with these standards, the details of which are not provided in this summary but are implied to have been conducted by the manufacturer. The primary method of demonstrating its safety and effectiveness for FDA 510(k) clearance is by showing substantial equivalence to existing predicate devices (K993801, K061180, K041610, K960640), noting that "minor differences in design and dimensions have no effect on the performance, function or intended use of the device and do not raise any new issues of safety and effectiveness." There is no mention of AI or machine learning components in this device or its assessment.

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The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures .

The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.

The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel.

The instruments are reusable; they are intended to be cleaned, sterilized and reused.

The Trokamed GmbH Endoscopes and accessories consist of:

• A Various manually operated surgical instruments
• A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems

• Several Endoscopes (Arthroscope, Cystoscope)

The provided document is a 510(k) summary for Endoscopes and accessories by Trokamed GmbH. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document. This document is a regulatory submission, not a research study report.

However, I can extract the following relevant information:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity). Instead, the "acceptance criteria" for regulatory approval are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices.

The "reported device performance" is not expressed in quantitative metrics in this document. The performance is implied to be equivalent to the predicate devices based on design and intended use.

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. The document does not describe a clinical study with a test set of data. The assessment is based on a comparison to predicate devices and adherence to standards.

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. No test set with ground truth established by experts is mentioned.

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

• Not applicable / Not provided. 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 / Not provided. This device is an endoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable / Not provided. As stated above, this is not an AI algorithm.

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

• Not applicable / Not provided. The concept of "ground truth" for a performance study is not addressed for this type of device submission. The primary ground for approval is substantial equivalence to existing devices.

8. The sample size for the training set

• Not applicable / Not provided. This document does not describe a machine learning algorithm or a training set.

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

• Not applicable / Not provided.

Summary of available information related to performance/safety demonstration:

The document indicates that the device meets safety and effectiveness requirements by:

• Substantial Equivalence: Listing several predicate devices by other manufacturers (Richard Wolf, Hans Hermann, Ackermann) with similar intended uses and design. This is the primary "proof" of meeting regulatory acceptance criteria.
• Biocompatibility: Stating that "The biocompatibility has been approved based on ISO 10993 parts one, five and ten by the accredited Laboratory Bioservice." This implies a study was done by an accredited lab to these ISO standards, with the internal acceptance criteria of those standards being met. However, the specific results or parameters are not detailed.
• Sterilization by User: Providing recommendations for sterilization (steam-sterilizer at 134°C / 270°F, 3 bar, for 10 minutes), implying that the device is designed to withstand and be effectively sterilized by such methods. This would have been validated internally by the manufacturer, but the validation study details are not provided in this summary.

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The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.

The instruments are reusable; they are intended to be cleaned sterilized and reused.

electrosurgical instruments and accessories

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) Summary for Trokamed GmbH's electrosurgical instruments and accessories, which focuses on device description, classification, intended use, substantial equivalence to predicate devices, biocompatibility, and sterilization by the user. It also includes an FDA letter acknowledging the substantial equivalence determination and indicating the device can be marketed.

Therefore, I cannot fulfill your request for the detailed table and information regarding acceptance criteria and studies as it is not present in the provided text.

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