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The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.

Ambu Neuroline Ground electrode should only be used by or on the order of a physician.

Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination.

Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device.

Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.

The provided text describes a 510(k) summary for the Ambu Neuroline Ground electrode. It is a submission for a medical device seeking clearance based on substantial equivalence to existing legally marketed predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not in the context of clinical performance metrics like sensitivity or specificity. Instead, they refer to the demonstration of substantial equivalence to predicate devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "laboratory tests" and "aging test" but does not quantify the number of electrodes or test cycles used.
• Data Provenance: Not explicitly stated, but the tests are described as "laboratory tests" implying they were conducted in a controlled environment by the manufacturer (Ambu A/S). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense.

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

• Number of Experts: Not applicable. For this type of device and 510(k) submission, "ground truth" is not established by clinical experts in the way it would be for diagnostic algorithms. The ground truth here is derived from the established performance and safety profiles of the predicate devices, against which the new device's engineering and material properties are compared.
• Qualifications of Experts: N/A.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There was no clinical study involving human interpretation or adjudication. The non-clinical tests likely involved objective measurements and comparisons to pre-defined engineering specifications or performance metrics of the predicate devices.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is an electrode device, not an AI or imaging diagnostic tool.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device (an electrode), not an algorithm or software. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this submission is the established performance and safety characteristics of the legally marketed predicate devices. The new device aims to demonstrate substantial equivalence to these existing devices through comparison of technological characteristics and non-clinical test results. In essence, the predicate devices are the "ground truth" for what is considered safe and effective for this product type.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

• Ground Truth for Training Set: Not applicable.

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The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).

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This document is a 510(k) premarket notification from the FDA for a medical device called the "Ambu® SPUR® II Adult Single Patient Use Resuscitator." This type of document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. This substantial equivalence is assessed based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria and ground truth as would be reported for an AI/ML diagnostic device.

Therefore, I cannot provide the requested table and information based on the provided text.

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The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).

The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Ambu, Inc. regarding their Ambu® SPUR® II resuscitators. This document primarily focuses on regulatory approval and indications for use.

It does not contain any information about:

• Acceptance criteria for a device's performance regarding a specific study.
• Results from any studies proving criteria are met.
• Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.

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This is a 510(k) premarket notification for a medical device (Ambu Disposable ECG Electrode) and as such, it does not typically contain detailed studies with acceptance criteria and performance metrics in the same way a clinical trial report would for a novel device. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present and explain why other information is not available.

Here's a breakdown based on the provided document:

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

This document (510(k) summary) does not include a direct table of acceptance criteria and reported device performance for a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which usually involves comparing design, materials, indications for use, and performance characteristics. The performance is typically demonstrated through bench testing and often, but not always, limited clinical testing, which are then compared to the predicate device's known performance. The specific performance data and criteria would be in the full submission, not usually in the publicly available summary.

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

Not available in the provided document. A 510(k) summary typically doesn't detail the sample size or provenance of specific test data unless it's a critical part of demonstrating substantial equivalence for a novel aspect. It's likely that a variety of bench tests were performed on a sample of electrodes, but specifics are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/available. For an ECG electrode, ground truth for performance is established through objective electrical and biocompatibility testing (e.g., impedance, adhesion, irritation) against established standards or predicate device performance, not typically by expert review of "truth" in the same way an imaging AI algorithm would be.

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

Not applicable/available. Adjudication methods are typically used in studies where human interpretation of medical data is being evaluated, such as in imaging or clinical diagnoses. For an ECG electrode, objective test results are generally compared to pre-defined thresholds or predicate device results.

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. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that interpret complex data, such as imaging. An ECG electrode is a passive measurement device; it doesn't "interpret" data in a way that would involve human readers or AI assistance in this context.

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

Not applicable. There is no algorithm in the "Ambu Disposable ECG Electrode" to perform standalone analysis. It is a physical device used to acquire physiological signals.

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

The "ground truth" for an ECG electrode would generally refer to specific performance metrics established through validated testing methods, such as:

• Electrical Performance: Impedance, DC offset, combined offset instability, defibrillation overload recovery (as per ANSI/AAMI EC12:2000 standard).
• Adhesion: Adhesion strength over time.
• Biocompatibility: Absence of cytotoxicity, irritation, sensitization (as per ISO 10993 standards).

These "ground truths" are verified through standardized bench tests and potentially limited human use studies for skin irritation, but not through expert consensus on diagnostic interpretation or pathology, as the device doesn't make a diagnosis. The document does not specify which of these were used or the details of the testing.

8. The sample size for the training set

Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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Ambu Disposable Pressure Manometer will be used to provide visual indication of the patient's airway pressure and may be attached to the manometer port on venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.

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The provided document is a 510(k) premarket notification letter from the FDA to Ambu, Incorporated, for their "Ambu Disposable Pressure Manometer". This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other administrative aspects, but it does not detail:

• Acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, expert numbers/qualifications, or adjudication methods for test sets.
• Information on MRMC studies, standalone algorithm performance, or ground truth types.
• Training set details or ground truth establishment for a training set.

This type of information would typically be found in the 510(k) submission itself (which is not provided), or in a separate study report or technical documentation that supports the submission. The letter only serves as an approval of the device's substantial equivalence.

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The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent. The electrode is for single patient use only.

Each electrode consists of a foam material with an adhesive to be mounted on the patient. The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point. On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe. The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch. The electrode is non sterile and intended for single use.

This 510(k) summary does not contain the detailed study information needed to fully address all parts of your request. It mainly describes the device and claims substantial equivalence to a predicate device. However, I can extract the available information and highlight what is missing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to a general standard.

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

The document does not specify a "test set" in the context of clinical performance evaluation with a numerical sample size. The substantial equivalence argument primarily relies on material changes and adherence to a standard, rather than a clinical trial with a defined test set.

• Sample Size: Not specified for a performance test set.
• Data Provenance: Not applicable in the context of a "test set" for clinical evaluation. The comparison is primarily in vitro based on materials and design, and in silico regarding MR safety and X-ray translucency.

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

Not applicable. This submission concerns a medical device accessory (ECG electrode) and relies on technical specifications and substantial equivalence, not a ground truth established by medical experts for a diagnostic performance study.

4. Adjudication Method for the Test Set

Not applicable, as a test set for clinical performance requiring adjudication is not described.

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

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging algorithms where human readers' performance with and without AI assistance is evaluated.

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

No, a standalone performance study in the context of an algorithm is not discussed. This device is an electrode, not a standalone diagnostic algorithm. Its performance is tied to its physical properties and ability to reliably transmit an electrical signal according to industry standards.

7. Type of Ground Truth Used

The "ground truth" for this device, implicitly, is:

• Physical and material properties: Ensuring non-ferromagnetic characteristics for MR safety and X-ray translucency.
• Adherence to AAMI EC12 2000 standard: This standard sets performance benchmarks for ECG electrodes (e.g., impedance, offset voltage, noise) which are considered "ground truth" for electrical signal transmission quality.
• Substantial equivalence to the predicate device: The predicate device (SUPAtab) has an established history of safe and effective use, so matching its performance in critical aspects serves as a form of "ground truth."

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this device is not a machine learning algorithm.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

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Based on the provided document, the "Single Patient EEG/EP Cup Electrode" received 510(k) clearance (K032278) from the FDA on March 5, 2004. This document is a clearance letter and an "Indications for Use" statement, not a detailed study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the device demonstrated that it is as safe and effective as a device already on the market. However, the details of the testing performed to demonstrate this substantial equivalence are not present in this document.

To answer your request, an extensive search for the 510(k) premarket notification (K032278) and its supporting documentation would be required. This usually involves reviewing the full submission made by Ambu, Inc. to the FDA, which is typically not publicly available in this level of detail without a Freedom of Information Act (FOIA) request.

Therefore, I cannot provide a table of acceptance criteria and reported device performance and other study details based solely on the provided FDA clearance letter and Indications for Use.

The document only confirms:

• Trade/Device Name: Single Patient EEG/EP Cup Electrode
• Regulation Number/Name: 21 CFR 882.1320, Cutaneous electrode
• Regulatory Class: II
• Product Code: GXY
• Indications For Use: The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring, and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
• Predicate Device: Not explicitly named in this document but would have been part of the 510(k) submission.

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Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.

The Paediatic Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.

The electrode can be used with mono- and biphasic defibriliators.

The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).

Disposable electrode, for single use, only,

The electrode is intended for use on defibrillators who's output is maximum 100 Joule.

Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.

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This document is a 510(k) clearance letter from the FDA for a medical device: "Ambu Pediatric Multi-Function Defibrillation Electrodes." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.

The "Indications for Use" section (page 2) describes what the electrodes are designed for (defibrillation, pacing, monitoring ECG, synchronized cardioversion) and specific patient/device parameters (pediatric patients < 10kg, external defibrillators or pacemakers, mono/biphasic defibrillators, max 100 Joule output). However, these are use specifications, not performance acceptance criteria or study results.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, device performance, or details of a study.

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The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).

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Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided document is a 510(k) clearance letter from the FDA for the Ambu Neonate Silicone Resuscitator. It does not contain the acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the way a performance study for an AI/ML device would.

Instead, this document grants clearance based on the determination that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA reviewed information submitted by Ambu (in their 510(k) submission, not provided here) and concluded that the new device is as safe and effective as existing devices on the market for its intended use.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies for this particular document, as those details are not part of a 510(k) clearance letter. These types of studies and criteria are typically associated with performance testing for new and complex medical devices, especially AI/ML-driven ones, and are included in the underlying 510(k) submission, not the clearance letter itself.

The key information from this document is:

• Device Name: Ambu Neonate Silicone Resuscitator
• Regulatory Class: II (two)
• Product Code: 73 BTM
• Indications For Use: The Ambu Neonate Silicone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).
• Approval Date: May 17, 2000
• Basis for Approval: Substantial equivalence to legally marketed predicate devices.

If this were a description of an AI-driven device and its performance study, the information would be structured as follows:

(Hypothetical Example if the document did contain the requested information for an AI device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): [Number] cases (e.g., 500 images)
• Data Provenance: [Country of origin (e.g., USA, multi-national across Europe and Asia), Retrospective/Prospective, (e.g., Retrospective, de-identified chest X-rays from hospitals in the US and Germany)]

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

• Number of Experts: [Number, e.g., 3 or 5]
• Qualifications: [e.g., Board-certified Radiologists with >10 years of experience in pulmonary imaging, and 2 expert thoracic surgeons.]

4. Adjudication method for the test set:

• [e.g., 2+1 (two initial readers, third adjudicator for disagreement), 3+1 (three initial readers, 4th adjudicator for disagreement), Simple majority, Consensus meeting, No adjudication (single reader for ground truth)]

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:

• [Yes/No]
• Effect Size: [e.g., Human readers' sensitivity for lesion detection improved by an average of X% (e.g., 15%) when using AI assistance (from Baseline Y% to Z%), accompanied by a reduction in reading time by A% (e.g., 20%).]

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

• [Yes/No]

7. The type of ground truth used:

• [e.g., Expert consensus (as described in #3), Pathology reports (biopsy-confirmed), Clinical outcome data (validated by long-term follow-up), Surgical findings, Combination of the above.]

8. The sample size for the training set:

• Sample Size (Training Set): [Number] cases (e.g., 50,000 images)

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

• [e.g., Each case was annotated by a single board-certified radiologist, followed by a double-check by a senior radiologist. Automated extraction from electronic health records, where diagnoses were confirmed by at least two independent clinical notes. Utilized a combination of expert labeling and pathology reports for a subset of the data.]

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