Search Results

Ask a specific question about this device

Ask a specific question about this device

Short-term (

Pregelled electrodes are of Aq/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

The provided text describes a 510(k) submission for ECG electrodes, which are hardware devices, not AI/ML software. Therefore, many of the requested categories in the prompt are not applicable. The core of the submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study with the detailed elements requested for AI/ML.

Here's an attempt to address the prompt based on the available information, noting where information is not applicable:

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

The submission demonstrates substantial equivalence to predicate devices rather than meeting specific quantifiable performance metrics. The implicit "acceptance criteria" for a 510(k) are that the device is as safe and effective as a legally marketed predicate. The "reported device performance" is that it is identical in composition, function, and design, and has comparable biocompatibility.

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. This is not a study assessing AI/ML software performance. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and biocompatibility testing, not clinical "test sets" in the AI/ML context.

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. Ground truth establishment for a test set is not relevant for this type of device submission.

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

Not applicable. Adjudication for a test set is not relevant for this type of device submission.

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 passive ECG electrode, not an AI/ML system designed to assist human readers.

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

Not applicable. This is a hardware device (ECG electrode), not an algorithm.

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

Not applicable. Ground truth is not a concept applied in this context for ECG electrodes. What is relevant is the established safety and efficacy of the predicate device, against which these electrodes are being compared for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Ask a specific question about this device

ECG monitoring electrodes for short-term use (

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 55 mm in diameter or rectanqular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

In this 510(k) summary, the device under review is the Niko ECG Monitoring Electrodes. The submission states that these electrodes are "identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes Models 4600 and 4610 previously distributed by Nikomed USA, Inc. (K950479)."

Therefore, the submission does not present specific acceptance criteria or performance studies for the Niko ECG Monitoring Electrodes. Instead, it relies on substantial equivalence to the predicate device. This means that the device is deemed to meet the performance requirements by being equivalent to a device already cleared by the FDA.

Given this, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are detailed for the Niko ECG Monitoring Electrodes.
2. Sample sizes used for the test set and the data provenance: No test sets or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not applicable as no new studies were conducted.
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 a medical device (ECG electrodes), not an AI algorithm for diagnostic imaging.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The provided document describes a 510(k) submission for Niko ECG Monitoring Electrodes. The entire premise of this submission is predicated on substantial equivalence to a previously cleared predicate device: Disposable ECG Monitoring Electrode Models 4600 and 4610 (K950479) from Nikomed USA, Inc.

Therefore, the acceptance criteria are implicitly met because the device is stated to be "identical in composition, function and design" and to have "the same intended use" as the predicate device. No new studies were conducted to prove the current device meets specific acceptance criteria, as the regulatory pathway chosen (510(k)) allows for reliance on equivalence to a legally marketed device.

Ask a specific question about this device

ECG monitoring electrodes for short-term use (

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

The provided text is a 510(k) summary for the Niko ECG Monitoring Electrodes and a letter from the FDA regarding its clearance. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

The document only states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness. The 510(k) process typically relies on demonstrating substantial equivalence rather than requiring a full clinical trial with defined acceptance criteria and detailed performance studies in the way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

ECG monitoring electrodes for short-term use.

Pregelled electrodes are of Aq/AqCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

The provided text is a 510(k) summary for the Niko ECG Monitoring Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics for the new device.

Therefore, the document does not contain the information required to populate the table of acceptance criteria and device performance or to describe a study proving the device meets those criteria, as typically understood for a new product performance study.

Specifically, the text states: "The Niko ECG Monitoring Electrodes are identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes... Accordingly Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models... are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes."

This is a statement of self-assessment based on identity to predicate devices, not a study performing specific tests against predetermined acceptance criteria.

To address the prompt as accurately as possible given the provided text, I will state that the product is claiming substantial equivalence to predicate devices, rather than establishing new performance criteria.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the Niko ECG Monitoring Electrodes in a study. It asserts that the device is "identical in composition, function and design" to predicate devices and therefore "perform at least as well."

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

• Cannot be provided. No test set or study is described for the Niko ECG Monitoring Electrodes. The claim is based on substantial equivalence to existing predicate 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)

• Cannot be provided. No test set or ground truth establishment process is described.

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

• Cannot be 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

• Cannot be provided. This is not an AI device, and no MRMC study or comparative effectiveness study is mentioned.

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

• Cannot be provided. This is not an AI algorithm; it is an electrode. No standalone performance study is mentioned.

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

• Cannot be provided. No ground truth is established for the Niko ECG Monitoring Electrodes as no distinct performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This is not a machine learning device, and no training set is mentioned.

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

• Cannot be provided. This is not a machine learning device, and no training set or its ground truth establishment is mentioned.

Summary based on the provided text:

The submission K990113 for the Niko ECG Monitoring Electrodes does not involve a study to prove the device meets specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The core argument is that the Niko ECG Monitoring Electrodes are "identical in composition, function and design" and have "the same intended use" as several legally marketed predicate devices from Nikomed USA, Inc. Therefore, the conclusion is that the Niko electrodes "perform at least as well as other disposable ECG monitoring electrodes."

No specific quantitative acceptance criteria, performance data, test sets, expert reviews, ground truth establishment, or training sets are described in the provided sections of the 510(k) summary. This type of 510(k) submission typically leverages existing data and regulatory approvals of the predicate devices.

Ask a specific question about this device

ECG monitoring electrodes for short term use (

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

The provided document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for ECG monitoring electrodes, detailing administrative information, device names, predicate devices, device description, and intended use, along with the FDA's letter of substantial equivalence. It does not provide performance data, study design, or methodology for assessing the device's performance against specific criteria.

Ask a specific question about this device

The Maersk Medical Contour infusion set is indicated for subcutaneous delivery of appropriately labeled fluids or solutions from an external infusion pump.

The Contour Infusion Set is an infusion administration set, connecting to a medicine reservoir syringe (such as the MiniMed® reservoir, model 103, that is placed in an external infusion pump such as the MiniMed insulin pump) and inserted in the subcutaneous tissue of a user. The Maersk Medical Contour Infusion Set may be used with any microbore infusion pump reservoir which utilizes a standard Luer connector.

The administration set attaches to the reservoir/syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane.

The 25 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub.

It appears that the provided document is a 510(k) Premarket Notification for the Maersk Medical Contour Infusion Set.

Based on the content, this document is a submission to the FDA seeking clearance for a medical device by demonstrating its substantial equivalence to a predicate device. It is not a study reporting on the device's performance against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such a study is not presented in this document.

The document primarily focuses on:

• Description of the new device: Maersk Medical Contour Infusion Set.
• Identification of a predicate device: Maersk Medical Comfort Infusion Set.
• Comparison of technological features: Stating substantial similarity to the predicate device.
• Intended Use/Indications for Use: Subcutaneous infusion of medicine from an external infusion pump.
• FDA's response: Letter confirming substantial equivalence and clearance to market.

In summary, there is no information in the provided text to fulfill your request regarding acceptance criteria and a study proving the device meets them. The 510(k) process is about demonstrating substantial equivalence, not typically about presenting a detailed performance study with acceptance criteria in the format you've requested.

Ask a specific question about this device

The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"

The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.

The provided text describes a 510(k) premarket notification for a medical device, specifically a 4L drainage bag. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (K843480), rather than establishing new performance criteria through a detailed clinical study.

Therefore, the input requests for acceptance criteria, study details, and related metrics often found in a de novo or PMA submission are not directly applicable in the same way for this 510(k). The "performance data" mentioned focuses on demonstrating equivalence to the predicate, not on setting and meeting new, specific performance thresholds against a defined clinical outcome.

Here's an analysis based on the provided text, addressing the requested points where information is available or noting when it's not applicable in the context of a 510(k) for substantial equivalence:

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Maersk Medical 4L drainage bag's acceptance criteria and the "study" to prove it meets them are primarily framed around demonstrating substantial equivalence to a previously cleared predicate device (K843480). This means the acceptance criteria are implicitly that the 4L drainage bag performs at least as safely and effectively as the predicate device for its intended use, despite minor modifications (increased volume and added comfort features). The "study" largely consists of functional and quality testing to support this claim of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are not explicitly quantitative performance metrics in the way one might see for a novel device. Instead, they relate to maintaining the functional and quality characteristics of the predicate.

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

The document does not specify a "test set" in the context of a clinical trial or large-scale data analysis. The "performance data" mentioned refers to functional and quality testing, which typically involves a sample of manufactured devices. The specific sample size for these engineering tests is not provided.

• Data Provenance: The testing would have been conducted by Maersk Medical A/S in Denmark (manufacturing facility location). The data is retrospective in the sense that it evaluates the modified device's performance against the established performance of the predicate device, and prospective in that the specific tests were conducted on the newly manufactured 4L bags.

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

Not applicable or not specified in this 510(k) submission. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for demonstrating substantial equivalence of a drainage bag. The "ground truth" here is the established safety and effectiveness of the predicate device, as determined by the FDA during its original clearance. The "experts" involved would be the engineers and quality assurance personnel at Maersk Medical conducting the functional and quality tests.

4. Adjudication Method for the Test Set

Not applicable or not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This is not the type of study presented for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate diagnostic systems, often AI-assisted, and are not relevant for a drainage bag that collects fluid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a passive medical device (a drainage bag), not an algorithm or an AI-enabled system. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (K843480). The modifications to the 4L drainage bag are demonstrated to align with this established profile through functional and quality testing. There is no clinical "ground truth" (e.g., pathology, clinical outcomes) generated for this specific submission, as it relies on the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this device.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device