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To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.

The document is a 510(k) clearance letter from the FDA for a device named EvaQMax Smoke Evacuation System, product code FYD. This is a physical device used to remove and filter smoke and aerosols from a surgical site, not an AI/ML-driven device.

Therefore, I cannot provide details on:

• Acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies related to AI/ML device validation.

The document discusses regulatory information for a non-AI/ML medical device, including its classification, regulations, and reporting requirements.

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Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only.

Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.

The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

This document describes the premarket notification for Bio Protech, Inc.'s Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, and Disposable Hypodermic Needle Electrodes. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating similar performance characteristics to predicate devices and adherence to relevant standards. The "Substantial Equivalence Chart" (Pages 5-7) directly compares the new device with predicate devices across various characteristics.

For "Performance", the report states:

• Acceptance Criteria (Implied): Equivalent penetration and friction force to predicate devices, and electrical properties conforming to DIN 13097. Assurance of functionality during the shelf life through aging tests. Optimal bevel and burr for sharpening, and electrical continuity and isolation of all poles.
• Reported Device Performance:
  • Disposable Concentric Needle electrodes: "Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product."
  • Disposable Hypodermic Needle electrodes (under the "Performance" row for Concentric, but appears to relate to Hypodermic based on context within the table): "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
  • Disposable Monopolar Needle electrodes / EP Needle electrodes: "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"

The overall conclusion states: "The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device."

Summary of Studies and Information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • The document does not specify the sample sizes used for the bench testing (penetration, friction force, electrical properties, aging, EO residual, biocompatibility).
   • Data Provenance: The accelerated aging testing was conducted by KTR (Korea Testing and Research Institute). Biocompatibility evaluations were performed for manufactured and sterilized Bio Protech electrodes. The provenance of the specific test samples (e.g., country of manufacture) is not detailed beyond the company's location in Republic of Korea. All testing appears to be prospective testing of the Bio Protech device.

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

   • This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring expert interpretation of medical images or patient data to establish ground truth.

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

   • This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring adjudication of medical interpretations.

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 or comparative effectiveness study involving human readers or AI assistance was conducted or described in this document. This device is a disposable needle electrode, not an imaging or diagnostic AI device.

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

   • No standalone algorithm performance study was conducted. This device is a physical medical device (needle electrodes), not an algorithm or AI.

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

   • For the performance testing, the "ground truth" or reference was based on established industry standards (e.g., DIN 13097 for mechanical and electrical properties, ASTM F 1980 for aging, ISO 10993 for biocompatibility, ISO 10993-7 for EO residuals) and direct comparison to the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only.

Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only.

Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

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I am sorry, but this document contains general correspondence regarding an FDA 510(k) premarket notification for "Disposable Adhesive Surface Electrodes" and "Disposable/Reusable Cup Electrodes."

The document does not describe "acceptance criteria" for a study, nor does it present any "study that proves the device meets acceptance criteria" in the way one would analyze a medical device's performance in clinical or diagnostic tasks.

Instead, the document primarily focuses on:

• Regulatory classification: Class II (Special Controls) for Cutaneous Electrodes.
• Substantial equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
• General regulatory requirements: Information about annual registration, labeling, manufacturing practices, etc.
• Indications for Use: What the electrodes are intended for (e.g., recording and monitoring biopotential signals like EEG, sEMG, EP).

Therefore, I cannot provide the requested information, which typically pertains to performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI/CADe devices. This document is related to a much simpler, non-AI medical device.

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PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

PROPENCIL Smoke Evacuation pencil consists of two types of disposable Smoke Evacuation monopolar pencils with finger controlled button switch or rocker switch for cutting and coagulation, and also suction cap, tube, hose are all included. All products are sterile, single-use, and disposable. The method of sterilization is Ethylene Oxide. The finger controlled switch is push button or rocker switch and the blade is an uncoated stainless steel electrode or ceramic coated non-stick blade.

PROPENCIL Smoke Evacuation pencil is designed to work with standard electrosurgical generators utilizing a 3-pin monopolar connection port and smoke evacuation units utilizing 8-to-22 hose connector. The tube is located near the electrode tip.

PROPENCIL Smoke Evacuation pencil is available with either a push button or a rocker switch, and some models include an optional holster. Most importantly the suction cap can be replaced with longer ones to extend the length of smoke pencil. The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.

This document is a 510(k) summary for the PROPENCIL™ Smoke Evacuation Pencil, an electrosurgical cutting and coagulation device with smoke evacuation capabilities. It compares the device to two predicate devices: LiNA Medical SafeAir (K120454) and Conmed, Inc. ClearVac (K982309).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical thresholds in a dedicated table format for all performance aspects. Instead, it states that the device "outperformed the predicate device" or "passed" certain tests. The "Substantial Equivalence Chart" (page 5) serves as a comparative performance assessment against predicate devices.

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

• Smoke Evacuation Performance Test: The document states "Bio Protech performed smoke evacuation bench comparison testing" but does not specify the sample size (e.g., number of devices tested, number of tests performed).
• Electrical Performance Test: For the worst-case EBE65N blade, it was "tested by INTERTEK." For other blades, "Bio Protech in-house" tested them. The sample size is not explicitly stated (e.g., how many units of each blade type were tested).
• Thermal Zone Damage Test: The document states "Bio Protech performed the thermal zone damage... by comparing visually assessed" against a predicate. The sample size of devices or assessments is not provided.
• Sterility and Shelf Life Testing: While accelerated aging tests and sterility validation were conducted, the sample size for these tests is not specified.

Data Provenance:

• The tests were conducted by Bio Protech, Inc. (the manufacturer), and for certain electrical safety tests and the worst-case electrical performance test, by INTERTEK (a third-party testing organization).
• The data is retrospective in the sense that it's generated from lab tests of the manufactured device.
• The manufacturer's location is the Republic of Korea (Donghwa Medical Instrument Complex).

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

This information is not provided in the document. The tests described are primarily bench tests and comparisons against predicate devices, not expert human evaluations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable for the reported bench and performance tests, as these did not involve human interpretation or subjective assessment that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The studies mentioned are bench tests and comparisons, not studies involving human readers or clinical scenarios.

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

No, this device is a physical electrosurgical pencil, not an algorithm. This question is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for the performance comparisons seems to be based on:

• Performance of predicate devices: The device performance was compared against established predicate devices (LiNA Medical SafeAir and Conmed ClearVac) in terms of smoke evacuation efficiency, electrical performance, and thermal zone damage.
• Compliance with international standards: For sterility (ISO 10993-7, EN ISO 11607-1) and electrical safety (IEC 60601-1, IEC 60601-2-2), the "ground truth" is adherence to these recognized industry standards.
• Visual assessment: For thermal zone damage, it was "visually assessed."

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

This question is not applicable for the same reason as point 8.

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PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

This document is a 510(k) clearance letter from the FDA for Bio Protech Inc.'s PROTENS Reusable Stimulating Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot provide a response to your request as the document does not contain the necessary information.

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Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.

Electrical stimulation current applications of these electrodes are:

• Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a)
• b) Electrical muscle stimulation (EMS)
• C) Functional electrical stimulation (FES)
• d) Microcurrent electrical nerve stimulation (MENS)
• Interferential stimulation (IF) e)
• f) Neuromuscular electrical stimulation (NMES)

Reusable Stimulating Electrodes

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Reusable Stimulating Electrodes." This document primarily focuses on regulatory approval and equivalence to predicate devices, rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, the information required to populate the table and answer the study-related questions (sample size, experts, ground truth, etc.) is not available in the provided text. The document is a regulatory approval, not a scientific study report.

Here's why and what can be inferred:

• Acceptance Criteria and Performance: The document does not list specific acceptance criteria (e.g., impedance values, lifespan, stimulating current delivery accuracy) or present performance data from a study. The FDA's review is based on substantial equivalence, implying the device performs similarly to existing, legally marketed predicate devices, but the explicit performance metrics are not detailed here.

• Study Details (Sample Size, Experts, Ground Truth, Adjudication, MRMC, Standalone, Training Set): None of this information is present. This document is a summary of the FDA's decision, not the full submission that would contain these study details. For a 510(k), manufacturers typically submit data to show their device is as safe and effective as a predicate device, which might involve bench testing, animal studies, or sometimes human clinical data depending on the device and its risk. However, the specifics of such internal studies are not part of this public letter.

In summary, based only on the provided text, I cannot complete the requested information. The document is a regulatory approval notice and does not contain the detailed study results and acceptance criteria you're looking for.

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The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

MAX-IF1000 Interferential Stimulator

The provided text is a US FDA 510(k) clearance letter for the MAX-IF1000 Interferential Stimulator. It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily:

• Identifies the device and applicant.
• States that the device has been found substantially equivalent to a legally marketed predicate device.
• Outlines general regulatory requirements for marketed devices (e.g., registration, labeling, good manufacturing practice).
• Provides contact information for various FDA divisions.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory clearance document, not a scientific study report or clinical trial summary.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or the relevant sections from a 510(k) submission that details performance testing.

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1. Relax muscles
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis
6. Maintaining or increasing range of motion

The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.

The provided text states that no clinical data was included in the submission for the MAXEMS 1000/2000 devices. Therefore, there is no study described that proves the device meets acceptance criteria based on clinical performance.

Instead, the determination of substantial equivalence was based on non-clinical tests, which concluded that "The MAXEMS series is as safe and effective as the predicate devices cited above."

Given the absence of clinical data, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
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, as this is not an AI device and no clinical effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used: Not applicable for clinical ground truth.
8. The sample size for the training set: Not applicable, as there was no clinical training set.
9. How the ground truth for the training set was established: Not applicable.

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The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.

The PROPENCIL ESU pencil (and as also to be offered for sale under various private label trade names) is intended for standard electrosurgical operation such as cutting and coagulation. It is designed to work with standard electrosurgical generators. PROPENCIL consists of various types of disposable ESU pencils with hand controlled switch for cutting and coagulation. All of products are sterile device. The method of sterilization is Gamma sterilization. The hand controlled switch is pushbuttons or rocker button and the blade is an uncoated stainless steel electrode or non-stick coated stainless steel electrode.

Here's a breakdown of the acceptance criteria and study information for the Bio Protech, Inc. PROPENCIL ESU Pencil, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information about a test set with a specific sample size, data provenance (e.g., country of origin, retrospective/prospective), or a formal clinical study to prove performance against acceptance criteria in a traditional sense. The submission focuses on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and adherence to recognized electrical safety standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the document. The device's safety and effectiveness were evaluated based on engineering testing to established standards, not through expert-reviewed ground truth on a specific dataset.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. There was no "test set" in the context of a clinical performance study that would require an adjudication method.

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

A MRMC comparative effectiveness study was not performed or reported. The submission does not involve human readers interpreting data, as it is an electrosurgical pencil. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

A "standalone" study in the typical AI sense was not performed or reported. The evaluation of the device's technical characteristics and adherence to safety standards can be considered a form of standalone testing, as it assesses the device's inherent performance. However, there is no mention of an "algorithm" or AI in this context.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily engineering standards and direct comparison of technical specifications against a legally marketed predicate device. This includes:

• Adherence to electrical safety standards (IEC 60601-2-2:2006, AAMI HF-18:2001).
• Direct comparison of physical characteristics, materials, and modes of operation to the predicate device.

There is no mention of pathology, outcomes data, or expert consensus on clinical cases being used as ground truth for this submission.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical electrosurgical pencil, not an AI/software device that would involve a training set.

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

This information is not applicable and not provided. As there is no training set mentioned, there is no ground truth establishment for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the Bio Protech, Inc. PROPENCIL ESU Pencil meets acceptance criteria is primarily an engineering-based substantial equivalence comparison to a legally marketed predicate device (Conmed. Inc. Hand Controlled Electrosurgical pencils, K896626).

The key elements of this "study" are:

• Comparison of Technical Characteristics: A detailed table was presented comparing the PROPENCIL's specifications (intended use, styles, mode of operation, tip configuration, bipolar/monopolar, materials, removable electrode, cable) directly against those of the predicate device. The acceptance criterion here was that the PROPENCIL's characteristics are similar enough to the predicate to not raise new safety or effectiveness concerns.
• Safety Testing to Recognized Standards: The PROPENCIL underwent testing to established international and national standards for medical electrical equipment:
  • IEC 60601-2-2:2006: A standard specifically for the safety of high-frequency surgical equipment. The device "Passed" this standard.
  • AAMI HF-18:2001 Cable Strain Relief Test: This standard addresses the durability and safety of the cable connection. The device also "Passed" this test.
    The acceptance criteria for these tests were successful compliance ("Pass") with the requirements outlined in each standard.

The conclusion drawn from this evaluation (as stated in the document) is that the PROPENCIL is similar to the predicate device in intended use, materials, and design, and introduces no new questions concerning safety and efficacy. This demonstrates that the device meets the regulatory acceptance criteria for substantial equivalence under a 510(k) pathway.

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The PROPLATE is a disposable, single-use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.

PROPLATE Electrosurgical Grounding Plate

The provided document is a 510(k) cleared by the FDA for the 'PROPLATE Electrosurgical Grounding Plate'. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It certifies that the device can be legally marketed and outlines regulatory compliance requirements.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically seen with performance data for AI/ML-enabled devices.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Information on a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This is because the device, an electrosurgical grounding plate, is a hardware medical device and not an AI/ML-enabled device. The concepts of "acceptance criteria" and "studies" as described in your prompt (e.g., ground truth, experts, training/test sets, MRMC studies) are typically relevant for the evaluation of AI/ML software as a medical device, diagnostic imaging tools, or other devices where performance is measured against a diagnostic or predictive outcome.

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