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The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity. The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen.

The EUM100Pro is intended for use on women in term (>36 completed weeks of gestation) labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer.

The EUM100Pro is built around an EN- 60950 certified computer. Analog signals are obtained from CE certified amplifier box from Delsys Inc., Boston, MA. Delsys also supply the input modules, power supply, electrodes and disposable stickers.

The system is comprised of a multi-channel surface electromyogram operative to sense electromyographic (EMG) activity, a three-dimensional position sensor and a personal computer providing data analysis, recording media and a graphical user interface.

Here's a summary of the acceptance criteria and study details for the EUM100Pro device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes the clinical study's purpose as providing "evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity."

Therefore, the implicit acceptance criteria are based on demonstrating substantial equivalence to predicate devices (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) in detecting and displaying uterine activity, as assessed by physicians.

Study Details

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

   • Sample Size: 43 women.
   • Data Provenance: The text does not specify the country of origin. It indicates the study was "conducted a clinical study enrolling 43 women at term gestation in active labor." The context suggests this was a prospective clinical study as women were enrolled specifically for this evaluation.

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

   • Number of Experts: Three (3) physicians.
   • Qualifications: The text only states "three physicians." No specific qualifications (e.g., years of experience, specialty) are provided.

3. Adjudication method for the test set:

   • The physicians "evaluated independently" and were "masked to the technology used to acquire the tracings." They were asked to annotate contractions and indicate the total number. The text does not explicitly state an adjudication method like 2+1 or 3+1 for discrepancies. It implies that the individual assessments of these three physicians, when compared across the different tracing types (EUM, TOCO, IUPC), formed the basis for concluding substantial equivalence.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported. This study assessed the standalone performance of the EUM100Pro device (which incorporates an algorithm) in comparison to established methods (TOCO and IUPC) as interpreted by physicians. The focus was on the device's ability to generate signals comparable to existing methods, rather than on improving human reader performance with aid.

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

   • Yes, a standalone evaluation of the EUM100Pro's output was done. The EUM100Pro is described as generating "graphs similar to the commonly use toco-dynamometer," and these tracings were presented to physicians for interpretation. The study was designed to show the device's performance in detecting and displaying uterine activity itself, which is a standalone function of the algorithm and hardware. The physicians then interpreted these device-generated tracings.

6. The type of ground truth used:

   • The ground truth was established by expert consensus/interpretation of established predicate technologies (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) and the EUM100Pro's own output, all compared simultaneously. The study design implicitly uses the TOCO and IUPC as the "established" or "reference" methods against which the EUM100Pro's output is compared, with expert physician interpretation serving as the ultimate arbiter of what constitutes a contraction on any of the tracings.

7. The sample size for the training set:

   • The document does not provide any information about a separate training set or its sample size. The clinical study described appears to be a validation or test set. Without information on an AI/ML component that requires explicit training, details about a training set are not included.

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

   • As no information on a training set is provided, the method for establishing its ground truth is also not stated.

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The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.

The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.

The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.

Here's a breakdown of the acceptance criteria and study information for the ClearPath Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence to predicate devices for the ClearPath Tubing, which is an irrigation tube for gastrointestinal endoscopic procedures. As such, the "acceptance criteria" are more related to functional performance and safety demonstration rather than specific quantitative metrics often seen with diagnostic devices.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size of patients or cases. The performance testing appears to be primarily engineering or bench testing focused on the physical integrity and function of the tubing itself. This type of testing typically involves a number of manufactured units but not a patient-centric test set.

• Sample Size: Not specified in terms of patient/case count. The testing focused on manufactured tubing units.
• Data Provenance: Not applicable in the context of patient data. The tests are likely internal laboratory tests.

3. Number of Experts and Qualifications

This information is not applicable. The device is an irrigation tube, and its performance testing as described focuses on physical properties (leakage, degradation) rather than diagnostic performance requiring expert interpretation.

4. Adjudication Method

This information is not applicable. There's no mention of a human-in-the-loop diagnostic study or a need for expert adjudication.

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

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is more common for diagnostic devices where AI assistance could impact human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The ClearPath Tubing is a physical medical device (irrigation tube), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on the satisfactory results of engineering tests (leak detection, material integrity, visible degradation) rather than clinical outcomes, pathology, or expert consensus on a diagnosis. The primary "ground truth" for regulatory approval is demonstrating substantial equivalence to predicate devices through functional and design similarities.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML-based system that requires a training set.

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

Not applicable. As noted, there is no training set for this type of device.

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A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to

The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.

The provided text describes a 510(k) premarket notification for a medical device called "Infant Feeding Tube with Non-IV fittings". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria in the context of an AI/ML medical device.

Therefore, the input does not contain the information requested for an AI/ML medical device study, such as acceptance criteria in the form of metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The document is a regulatory submission for a physical medical device (an infant feeding tube) that has been modified to change the connector type. The "performance" section explicitly states "None under Section 514", indicating that specific performance data (like clinical trials or performance assessments with acceptance criteria) were not required for this type of submission. The comparison is primarily focused on design features, indications for use, and materials to establish substantial equivalence.

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The BabyAir™ is a pneumatic nebulizer, UDN, with a hood, which nebulizes specific drugs for inhalation by a patient. The patient population includes infants. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a nebulizer. This product is a single patient, multi- use, non-sterile prescriptive device. It is intended to be used in either a hospital or homecare environment.

The BabyAir™ is comprised of: Transparent Hood Covering shield draped over a plastic base. Nebulizer Assembly - The Nebulizer converts the liquid medication into a fine aerosol mist and directs the aerosol toward the infant efficiently and safely. Compressor Not included. Any standard nebulizer compressor which has an operating flow rate range of 8 to 11 Lpm at no back pressure or has a pressure of 3 bar under a no flow conditions, may be used.

Here's a breakdown of the acceptance criteria and study information for the BabyAir™ device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the BabyAir™ as substantially equivalent to a predicate device. The primary acceptance criterion and the reported performance relate to Comparative Particle Size testing.

Note: The document does not specify quantitative acceptance limits for MMAD (Mass Median Aerodynamic Diameter) and GSD (Geometric Standard Deviation) that the predicate device met. Instead, it states that the BabyAir™ demonstrated "substantially equivalent" performance to the predicate device in these parameters. This implies the BabyAir™'s MMAD and GSD were within an acceptable range relative to the predicate.

Study Details

Based on the provided text, the study conducted for the BabyAir™ device was a comparative equivalency study focused on particle size.

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

   • Sample Size: Not explicitly stated. The document mentions "Comparative Particle Size testing via a Cascade Impactor" but does not give the number of tests performed or the amount of medication used.
   • Data Provenance: Not explicitly stated. Likely refers to testing conducted in a laboratory setting by the manufacturer or a contracted lab. There's no mention of country of origin for this specific test data, nor whether it was retrospective or prospective in the context of clinical data.

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

   • Not applicable as the study involved objective technical measurements of particle size, not subjective expert assessment as relevant for medical imaging or diagnostic devices. "Ground truth" in this context refers to the measured physical characteristics of the aerosol.

3. Adjudication Method for the Test Set:

   • Not applicable. The data came from a technical measurement device (Cascade Impactor), not from human interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and the AI's impact on reader performance is evaluated. The BabyAir™ is a medical device for drug delivery (nebulizer), not a diagnostic tool requiring image interpretation.

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

   • Yes, in effect, a standalone performance was done. The "Comparative Particle Size testing" is a direct measurement of the device's physical output (aerosol particle characteristics) without human intervention in its operation or interpretation of its direct output for efficacy. The "algorithm" here is the device itself in its function of nebulizing medication.

6. Type of Ground Truth Used:

   • Objective physical measurements/technical specifications. The ground truth for particle size testing is the scientifically accepted method of measuring aerosol characteristics, specifically MMAD and GSD using a Cascade Impactor. These are empirical measurements.

7. Sample Size for the Training Set:

   • Not applicable. This device does not use an "algorithm" in the sense of machine learning that requires a training set. The device's design and manufacturing process are essentially its "training" to produce the desired particle size.

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

   • Not applicable. As noted above, there's no machine learning training set for this device. The "ground truth" for the device's design would be established through engineering principles, regulatory requirements, and the performance characteristics of predicate devices, which guide the manufacturing process to achieve the desired output.

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The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to

The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

This document describes a 510(k) premarket notification for a medical device, the "Infant Feeding Tube." The submission seeks to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically the characteristics and performance of the predicate device. The "reported device performance" demonstrates that the new device meets or is equivalent to these characteristics.

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For use in a kit for nerve blocks or wound site pain management. To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous. As an accessory to Sorenson medical infusion pumps or as a standalone device, but not for use with gravity feed. Single patient use only.

The infusion catheter is a small bore, 20 gauge, tube with holes at the tip to permit dispersion of the modication into the site. The overall cather is 30" in length with various lengths of holes (fenestrations) of - 1.5", 3.0", and 5.0" with a standard Touly Borst connector. The catheter has markings on the shaft to provide a reference guide for the clinician. May be available in a kit. Provided stcrilc.

The provided text is a 510(k) Summary of Safety and Effectiveness for a Fenestrated Infusion Catheter. It focuses on device description, intended use, and a declaration of substantial equivalence to predicate devices. Crucially, this document does not contain information about acceptance criteria or specific studies proving device performance against such criteria.

The 510(k) process primarily demonstrates substantial equivalence to a legally marketed predicate device rather than outright proof of meeting specific performance metrics through detailed studies. The absence of this information is typical for a 510(k) summary, which often relies on comparative claims rather than standalone performance studies with quantified acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided document.

To clarify, a 510(k) submission generally includes:

• Device Description: What the device is and how it works.
• Indications for Use: What the device is intended for.
• Technological Characteristics Comparison: How the new device is similar to and different from predicate devices.
• Performance Data (if applicable): Bench, animal, or clinical data may be submitted to support substantial equivalence, particularly if there are new technological characteristics or safety/effectiveness concerns. However, the summary provided here does not detail such studies or specific acceptance criteria.

The document's statement: "The data within the submission demonstrates that the proposed device is safe, effective, and substantially equivalent when compared to the predicate devices" indicates that such data was submitted to the FDA, but the specific details of that data, including acceptance criteria and study designs, are not included in this "Non-Confidential Summary."

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The gas sampling lines are intended to connect to a port in the breathing circuit to the expired gas monitor. Disposable, single use.

Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.

The provided text, K0235-79, describes a 510(k) premarket notification for "Gas Sampling Lines." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and study methodologies for an AI/CADe device's clinical performance assessment is not applicable to this submission.

Here's why and what the document does discuss:

• Device Type: This submission is for medical tubing (Gas Sampling Lines), which are considered accessories for carbon dioxide gas analyzers. These are standard medical devices, not AI or CADe systems.
• Regulatory Pathway: The 510(k) pathway for these types of devices relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This typically involves engineering and bench testing, materials biocompatibility, and sometimes limited performance testing against established standards, but not clinical trials with performance metrics like sensitivity, specificity, or reader studies.
• Key Information Provided:
  • Intended Use: "The gas sampling lines are intended to connect from a port in the breathing circuit to the expired gas monitor. Disposable, single use."
  • Device Description: Small bore tubing of various internal diameters and lengths, connecting to a port in the breathing circuit, possibly with standard luer connectors and/or an in-line filter.
  • Predicate Devices: Catheter Research, Inc. - K946044 (Disposable gas sampling lines).
  • Performance Standards (Applicable): ISO 594-2 - Conical fittings for luer tapers. This is an engineering standard for luer connections, not a clinical performance standard.
  • Differences from Predicate: The submission states, "The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices." This implies that the tests performed (likely engineering and materials compatibility) showed no significant differences that would raise new questions of safety or effectiveness.

In summary, for K0235-79, the following information is not available or not applicable because it's a 510(k) for a non-AI/CADe device focused on substantial equivalence:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of clinical performance metrics. Instead, the "performance standard" mentioned is ISO 594-2.
2. Sample sized used for the test set and the data provenance: Not relevant for a device like this; studies would be bench/engineering tests, not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable in the context of clinical outcomes.
8. The sample size for the training set: Not applicable (no AI/ML model involved).
9. How the ground truth for the training set was established: Not applicable.

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The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30 day placement. Not intended for transpyloric placement.

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

The provided document is a 510(k) premarket notification for a medical device called "Infant Feeding Tube." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, the information requested in the prompt, which is typically found in clinical study reports for devices proving new claims or safety/effectiveness, is largely not applicable or present in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

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

The document does not specify formal "acceptance criteria" in terms of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy percentages) that would be met by a study. Instead, the "device performance" is demonstrated through a comparison of key attributes to predicate devices, showing that the proposed device shares the same intended use, design features, materials, and sterile packaging.

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