Search Results

The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.

A non-sterile, single use, colorimetric carbon dioxide indicator with integral luer-lock connector, for placement in a gas sampling ported component, located between a tracheal tube and the breathing circuit, to detect exhaled CO2.
Pressure in the breathing circuit causes a low flow of breathing gas to pass into and through the indicator and vent to the atmosphere. The colorimetric media in the center window of the device indicates the presence of carbon dioxide in exhaled breath on a breath-by-breath basis.
The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present. A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color.
The indicator has a color scale against which the actual color may be compared to provide an approximate carbon dioxide concentration. Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator.

The provided text describes a 510(k) premarket notification for a medical device called "C-CO2™ Colorimetric Carbon Dioxide Indicator." However, it does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed validation section of a 510(k) submission.

This document is primarily a summary of safety and effectiveness, an official FDA clearance letter, and the indications for use. It mentions performance characteristics in the device description (e.g., color changes indicating CO2 concentration), but it does not present quantifiable acceptance criteria or the results of a study designed to test against such criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader studies based on the provided text.

Here's what I can extract from the provided text based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds (e.g., "sensitivity must be >X%"). The device description generally describes expected color changes.
• Reported Device Performance:
  • Qualitative Description: "The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present."
  • Functionality: "A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color."
  • Interference: "Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator."

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

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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

• Not mentioned. The device's operation is based on a chemical reaction indicating CO2, not on expert interpretation of complex data.

4. Adjudication method for the test set:

• Not mentioned.

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 done. This device is a simple colorimetric indicator, not an AI-powered diagnostic system involving human readers.

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

• Not applicable/Not mentioned. The device itself is the "standalone" indicator, but no performance study in the context of an "algorithm" is described.

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

• Implicitly, the ground truth would be precise measurements of CO2 concentration (e.g., using a reference capnograph) and observation of the C-CO2 device's color change. This is not explicitly detailed as "ground truth" in the provided text.

8. The sample size for the training set:

• Not applicable/Not mentioned. This is a chemical indicator, not a machine learning algorithm requiring a training set.

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

• Not applicable/Not mentioned.

In summary: The provided document is insufficient to answer most of your detailed questions regarding acceptance criteria and performance studies. It is a regulatory clearance document that primarily focuses on the device description, indications for use, and substantial equivalence to a predicate device, rather than providing the detailed technical validation data.

Ask a specific question about this device

The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.

Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.

The provided text describes a 510(k) premarket notification for the Marquest SCT 3000 Heated Humidifier. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics of a device, especially not one using AI or machine learning. Therefore, I cannot fully complete the requested table and sections.

Here's an analysis based on the provided document, highlighting why certain questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics for the new SCT 3000 Heated Humidifier in the way a study for a diagnostic AI device would. Instead, it relies on comparison to predicate devices, indicating equivalency in function and safety features.

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

• Not applicable. This document is a 510(k) submission for a heated humidifier, not an AI/ML device that uses test sets or data. The "test set" in this context refers to the device itself being tested for compliance with standards and functional equivalence.

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

• Not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels or outcomes. For this medical device, safety and performance are assessed through engineering and regulatory testing against established standards and predicate device specifications.

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

• Not applicable. Adjudication methods are typically used in studies where multiple human readers assess data, and a consensus mechanism is needed to establish ground truth or resolve discrepancies, common in diagnostic imaging studies for AI.

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

• No. This is not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance would have been conducted.

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

• Not applicable. This is a hardware medical device, not an algorithm. Performance is assessed through engineering testing and compliance with regulatory standards.

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

• Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be derived from:
  • Engineering specifications and measurements: e.g., actual temperature readings, alarm activation thresholds.
  • Compliance with recognized standards: UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979.
  • Comparison to predicate device performance: Demonstrating the new device performs equivalently or better on critical safety and functional aspects.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the Study/Evidence:

The "study" presented here is a 510(k) premarket notification. The primary goal is to demonstrate "substantial equivalence" to legally marketed predicate devices (Marquest SCT 3000 - K903138 and Fisher & Paykel 730 Respiratory Humidifier - K913368).

The evidence provided focuses on:

• Device Description and Intended Use: Clearly outlining the function and purpose of the SCT 3000.
• Comparison Table (Attributes): A detailed comparison of the new SCT 3000 with its predicate devices across various attributes including:
  • Indications for use (anesthesia, respiratory therapy)
  • Targeted population (adult, pediatric, neonate)
  • Circuit types (heated wire, no-wire, specific manufacturer circuits)
  • Application types (single patient, reusable)
  • Chamber types (low flow, high flow)
  • Compatibility (ventilators, anesthesia systems)
  • Design features (microprocessor control)
  • Safety Features: High and low temperature alarms (with specific thresholds), maximum heater plate temperature, alarm mute duration, and safety alarm display.
  • Performance Testing: Stating compliance with specific national and international electrical and medical device safety standards (UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979).

The document explicitly states that "Any differences that do exist would not have an effect on the safety or effectiveness of the device," which is key to a 510(k) submission for substantial equivalence. The "study" is more of a regulatory compliance review of engineering specifications and testing against established standards and predicate device performance, rather than a clinical trial or AI evaluation study.

Ask a specific question about this device

The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.

The humidifier chambers offered for use with the SCT 3000.

• • Adult low flow humidifier chamber
• • Adult extended run humidifier chamber
• • Pediatric low compressible volume humidifier chamber
• • Adult hi flow humidifier chamber

This looks like a 510K submission for humidifier chambers, not an AI/ML medical device. As such, the requested information about acceptance criteria, clinical study designs, ground truth establishment, and AI performance metrics is not applicable to this document.

The document states:

• "Performance Testing: None applicable" - This explicitly indicates no specific performance tests were deemed necessary beyond comparison to predicate devices, which implies no formal clinical studies or detailed performance metrics were conducted or required.
• The entire submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than novel performance claims.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.

Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. Instead, the document describes "Heated wire breathing circuits and limbs" and compares them to predicate devices, focusing on attributes like intended use, design, and materials.

The document discusses "Performance Testing" by stating that the device "Meets ASTM breathing systems standard," but it doesn't provide details about:

1. Specific acceptance criteria: What are the numerical or qualitative thresholds that define "meeting the ASTM standard" for this device?
2. A study proving compliance: There's no description of a study (e.g., methodology, results, sample sizes) that demonstrates the device actually meets the ASTM standard.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or study types like MRMC or standalone. The document's purpose is to outline the device's characteristics and its similarity to existing devices for regulatory submission, not to detail the results of a performance study against specific acceptance criteria.

Ask a specific question about this device

Indicated use - When a sample of a patient's expired gas is to be analyzed.

Targeted population - Any patient requiring monitoring of expired gases.

Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy

The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter

The provided text describes a medical device (Gas Sampling Interface Kits) and compares it to a predicate device, but it does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific information you've asked for. The document focuses on establishing substantial equivalence to a predicate device based on intended use, design, materials, and generic performance testing (e.g., "Luer fittings: Yes" implies they perform as expected, but no specific metrics are given).

Here's an output demonstrating what I can extract and highlighting the missing information:

Description of Device: Gas Sampling Interface Kits (Disposable Gas Sampling Lines)

Intended Use: When a sample of a patient's expired gas is to be analyzed. Targeted population: Any patient requiring monitoring of expired gases. Environment of use: Hospital, anesthesia, ICU, PACU, respiratory therapy.

Predicate Device: Gibeck, Inc. - disposable gas sampling lines - K841722

Below is a table showing the available comparison points, but crucially, acceptance criteria and specific performance metrics are absent.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states "Performance Testing: Luer fittings: Yes" without providing any specific criteria (e.g., leak rate, pressure resistance) or quantitative results. The acceptance criteria for any performance characteristic are not provided. The reported device performance is implicitly considered acceptable due to its equivalence to the predicate device.

Missing Information (Not available in the provided text):

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not mentioned; this document describes a traditional device comparison, not an AI efficacy study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable in the context of this device and the provided document. The "ground truth" here is the functional performance and material composition, which are tested against engineering specifications (not detailed here) and compared to the predicate.
8. The sample size for the training set: Not applicable; this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable; this is a physical medical device, not an AI algorithm.

Ask a specific question about this device

Ask a specific question about this device