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The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM CV4 System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.

The ECOM CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressures.

The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube and an integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a Tube Cable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and power cordset.

The ECOM CV4 System applies a high frequency, low amplitude electrical current and measures the resulting voltage directly from the tracheal mucosa by way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor will display the tube and surface R-Wave and the Impedance Waveforms as well as the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV), Systolic and Diastolic Pressures.

The provided document describes the ECOM CV4 System, an Endotracheal Cardiac Output Monitor. However, the document (a 510(k) summary) focuses on regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study proving performance against specific acceptance criteria.

The clinical performance section states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." Unfortunately, the document does not specify what those acceptance criteria were, nor does it provide details about the clinical study itself.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

Reasoning: The document explicitly states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." However, it does not define what those acceptance criteria were (e.g., specific accuracy thresholds, precision values, sensitivity, specificity, etc.).

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

Cannot be determined from the provided text. The document only mentions "clinical data" was used but gives no details about the sample size, its origin, or whether it was retrospective or prospective.

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 determined from the provided text. The document does not describe how ground truth was established, which experts were involved, or their qualifications.

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

Cannot be determined from the provided text. There is no information regarding any adjudication process for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Cannot be determined. This device is an Endotracheal Cardiac Output Monitor, which outputs physiological measurements (Cardiac Output, Heart Rate, Stroke Volume, Pressures). It is not an AI-assisted diagnostic imaging system that involves human readers interpreting images. Therefore, a Multi-Reader Multi-Case (MRMC) study and "human readers improve with AI vs without AI assistance" are not relevant to this type of device.

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

Yes, implicitly. The device itself performs the measurement and displays the output (CO, SV, HR, etc.). While a human monitors and uses this information, the "performance" described (measuring cardiac output) is inherent to the device's function, implying a standalone assessment of its measurement capabilities. However, specific standalone performance metrics (e.g., accuracy against a gold standard) are not provided in detail beyond "met the acceptance criteria."

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

Cannot be determined from the provided text. The document mentions "clinical data" but does not specify the ground truth methodology used to validate the ECOM CV4's measurements. For cardiac output monitors, ground truth typically involves a more invasive, established method (e.g., pulmonary artery catheter thermodilution) against which the new device's readings are compared. This information is absent.

8. The sample size for the training set

Not applicable/Cannot be determined from the provided text. The ECOM CV4 is described as measuring physiological parameters via impedance cardiography. It's not a machine learning/AI device in the modern sense that typically has distinct "training" and "test" sets of data for algorithm development. Its "performance" refers to the accuracy and reliability of its physiological measurements, which would be validated against a reference method rather than trained on a dataset.

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

Not applicable/Cannot be determined from the provided text. See explanation for point 8.

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The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.

The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead.

IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate.

The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.

The provided document is a 510(k) summary for the IM2001 Pulse Oximeter. While it describes the device's intended use and substantial equivalence to a predicate device, it does not contain the detailed information required to fill out the requested table and answer all questions related to acceptance criteria and performance studies.

Specifically, the document primarily focuses on regulatory approval and substantial equivalence, not on the technical performance study details like sample sizes, ground truth establishment, or expert adjudication for performance criteria.

Therefore, many of the requested fields will be marked as "Not provided in the document."

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not provided in the document.
• Data provenance: Not provided in the document.

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 provided in the document.

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

• Not provided in the document.

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 pulse oximeter, not an AI-assisted diagnostic imaging device for human readers.

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

• The document implies general "performance testing" was done to establish substantial equivalence. However, the details of a standalone performance study with specific metrics are not provided. The pulse oximeter itself is a standalone device in operation, but the detailed study proving its accuracy is not described here.

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

• Not provided in the document. For a pulse oximeter, the ground truth for SpO2 would typically be derived from arterial blood gas analysis (co-oximetry), but this is not stated in the provided text.

8. The sample size for the training set

• Not applicable/Not provided. The document describes a medical device, not a machine learning algorithm that requires a "training set" in the typical sense.

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

• Not applicable/Not provided.

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Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

Here's an analysis of the provided text regarding the Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K991526), this device is a medical implant (brachytherapy seed) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth is not applicable. The regulatory pathway for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/SaMD would.

However, I can extract the relevant information from the provided document as it pertains to medical device approval, even without a direct AI component.

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI medical devices like brachytherapy seeds, "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices in terms of safety and effectiveness, and meeting relevant performance standards. The provided document doesn't list explicit, quantifiable acceptance criteria in the way a diagnostic AI algorithm might (e.g., "sensitivity > 90%"). Instead, the acceptance is based on demonstrating comparable characteristics and safety/biocompatibility.

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

• Not Applicable in the context of an "AI test set."
• For this type of device, the "testing" refers to bench testing for safety (e.g., radiation leakage, physical integrity) and biocompatibility, not performance on a dataset of patient cases. The document states "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." It does not specify sample sizes or data provenance for these engineering/material tests.

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

• Not Applicable. As this is a physical medical device (radioactive seed), there is no 'ground truth' in the context of expert diagnosis or interpretation of an AI output. The ground truth for such a device would be its physical properties, radiation output, and biological safety/biocompatibility, confirmed through laboratory and engineering tests, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" in the sense of medical images or patient data requiring expert adjudication for this device.

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

• No. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret cases. It is not applicable to a radioactive implantable seed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• For the purpose of substantial equivalence for this brachytherapy seed, the "ground truth" (or basis for comparison) is primarily:
  • Predicate Device Characteristics: The established safety, effectiveness, and technological characteristics of legally marketed I-125 brachytherapy seeds (e.g., Imagyn isoSTAR™ I-125 Interstitial Seed Model IS-12500, EndoSeed, Amersham Model 6711, Mentor IoGOLD).
  • Standard Test Outcomes: Results from "standard tests used for radionuclide devices" confirming physical integrity, radiation safety, and biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set."

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

• Not Applicable. No training set exists for this device.

Summary regarding the device:

The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The key elements for this determination were:

• Similar technological characteristics (encapsulation method, range of activity).
• No differences in biocompatibility or other safety and effectiveness aspects.
• Confirmation of safety and biocompatibility through "standard tests used for radionuclide devices."
• Identical intended use as predicate devices.

The regulatory process for this device did not involve clinical trials or performance assessments against diagnostic accuracy metrics, as it is a physical therapeutic implant rather than a diagnostic AI/software.

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The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.

Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.

This K980096 510(k) summary for the Imagyn Medical Technologies, Inc. Optical Aspirating Curette (OAC) does not contain the detailed acceptance criteria or the study data that "proves" the device meets these criteria in the way a modern AI/ML device submission would.

Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. The "study" here is essentially the argument for functional and technological equivalence, rather than a performance study with acceptance criteria and statistical analysis as is common for AI/ML.

Let's break down why this information is missing based on the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: In a traditional 510(k), particularly one from 1998, the "acceptance criteria" are implied by the performance of the predicate devices. The manufacturer's burden is to demonstrate that their new device performs as well as or in a similar manner to the legally marketed predicate devices for its intended use. There isn't a quantitative "performance" metric in the sense of accuracy, sensitivity, or specificity presented, because it's not a diagnostic AI/ML device.

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

• Sample Size: Not applicable in the context of a performance study for this type of device. There isn't a "test set" of patient data in the way you'd consider for an AI model. The "test" here is the comparison of technological characteristics and intended use to existing devices.
• Data Provenance: Not applicable. The "data" considered is the design, materials, and intended use of the OAC and its predicate devices.

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

• Number of Experts & Qualifications: Not applicable. There was no "ground truth" to establish for a test set of patient data. The regulatory body (FDA) reviews the technical specifications and comparisons provided by the manufacturer.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set of patient data requiring adjudication was performed.

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

• MRMC Study Status: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or documented in this summary.
• Effect Size: Not applicable, as no MRMC study was conducted.

Explanation: MRMC studies are typical for evaluating the impact of AI algorithms on human reader performance, especially in diagnostic imaging. This device is a manual surgical instrument, not an AI/ML diagnostic tool, so such a study would not be relevant.

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

• Standalone Study Status: No, a standalone performance study (algorithm only) was not done.
• Explanation: This device is a manual medical instrument that requires human operation. It is not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. No "ground truth" in terms of clinical outcomes, pathology, or expert consensus on a dataset was used for this submission. The "ground truth" for a 510(k) of this type is essentially the known safe and effective performance of the predicate devices.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI/ML algorithm involved, so no training set was used.

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

• Ground Truth for Training Set: Not applicable. No AI/ML algorithm or training set.

Summary of the 510(k) Approach for this Device:

This 510(k) submission relies entirely on substantial equivalence. The manufacturer argues that:

• The OAC curette component is similar to the Milex and Pipelle curettes.
• The OAC hysteroscope component is similar to Imagyn's MicroSpan Hysteroscope.
• Because the components are similar to already-cleared predicate devices, and the intended use is consistent with those predicates ("visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation"), the OAC should also be considered safe and effective.

The FDA's clearance letter confirms their determination of "substantial equivalence" based on this argument, meaning the device can proceed to market without new clinical performance studies demonstrating novel safety or effectiveness.

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The Impower device is used to assist in creating and maintaining an erection suitable for sexual intercourse. This device is intended for the treatment or management of erectile dysfunction/impotence.

The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.

The provided text is a 510(k) summary for the Imagyn Medical Technologies, Inc.'s Impower™ Vacuum Erection Device. This submission primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial or a more extensive performance evaluation for a novel device.

Therefore, many of the requested elements for describing acceptance criteria and study details are not present in this type of regulatory document. I will fill in the information based on what is available and explicitly state when information is not provided.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not provided. This submission relies on a comparison to a predicate device and its known performance, rather than new testing on a specific "test set" of patients.
• Data Provenance: Not applicable/Not provided.

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

• Number of Experts: Not applicable/Not provided.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, not applicable for this 510(k) submission.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the sense of a test set with established ground truth for performance metrics. The "ground truth" for this 510(k) submission is the performance and safety profile of the predicate device (Impower (Catalyst) System, 510(k) No. K920409), to which the new device is being compared for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/Not provided. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment: Not applicable.

Summary of the Study per the provided text:

The provided document describes a 510(k) notification of intent to market the Impower™ Vacuum Erection Device. The "study" presented here is a substantial equivalence comparison to a legally marketed predicate device, the Impower (Catalyst) System (K920409).

The core of the submission is the claim that the new Impower device is substantially equivalent because:

• It uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate device.
• It uses the same components and materials as the predicate device.

The FDA reviewed this claim and determined that the device is substantially equivalent for its stated indications for use (treatment or management of erectile dysfunction/impotence). This means that, based on the comparison provided, the FDA found no new questions of safety or effectiveness were raised by the new device compared to the predicate. No new clinical trials or performance studies with specific acceptance criteria and patient cohorts are described in the provided summary as being part of this 510(k) submission process.

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The ErecAid device is used to assist in creating and maintaining an erection suitable for sexual intercourse. These devices are intended for the treatment or management of erectile dysfunction/impotence.

ErecAid® System-OTC and StayErec® System Tension Rings-OTC
These devices are intended for the treatment or management of erectile dysfunction/impotence.

The Imagyn Medical Technologies, Inc. ErecAid System Classic vacuum erection system ("ErecAid") consists of a vacuum pump, tension rings, insert ring, clear plastic cylinder, and a tube of personal lubricant. The StayErec Tension Ring consists of a ring of the same material, and used in the same manner as the predicate device.

The provided text describes a 510(k) submission for the ErecAid™ Vacuum Erection and StayErec® Tension Ring Devices. This is largely a pre-market notification with a focus on demonstrating substantial equivalence to previously approved devices, rather than a clinical study evaluating novel performance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in this document. The document relies on equivalence to known predicate devices rather than new performance data against a specific set of acceptance criteria.

Here's a breakdown of the available information based on your request, with an emphasis on what is present and what is not:

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

This document does not present a table of acceptance criteria and specific performance metrics for the ErecAid and StayErec devices. The primary "acceptance criterion" being met is substantial equivalence to predicate devices. The document implies that the device performs equivalently to the predicate devices because it uses the "same vacuum method and technological characteristics" and "uses the same components and materials."

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

Not applicable. This document does not describe a clinical study with a test set. The determination of substantial equivalence is based on a comparison of technical characteristics and intended use with 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)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned as there's no clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical medical device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant or mentioned.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established performance and safety of the predicate devices. The new device is deemed acceptable because it is sufficiently similar to these already approved devices.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/machine learning device.

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

Not applicable.

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