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The modified Laparoshield Conditioned Insufflation Set ("Laparoshield") is intended to be used as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. It is indicated for use with CO2.

The modified Laparoshield consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a constant voltage/voltage limited power supply. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.

The Pall Medical Laparoshield Conditioned Insufflation Set is described as an accessory to an insufflator designed to heat, humidify, and filter a CO2 gas stream for laparoscopic surgery. The document provides information regarding its technological characteristics and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates." No specific sample size (i.e., number of units tested) for the test set is provided. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be bench testing conducted by Pall Medical as part of their premarket notification.

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

Not applicable. The performance testing described is bench testing of physical parameters (temperature and humidity output), not a clinical study involving expert assessment of images or patient outcomes. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was bench testing of physical characteristics, not a subjective assessment requiring adjudication.

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

No. The document describes bench testing of a medical device, not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was conducted in the form of bench testing. The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates. In all instances, the modified Laparoshield met its performance specifications." This directly assesses the device's performance without human interaction in its function.

7. Type of Ground Truth Used

The ground truth used was the predefined performance specifications for temperature and humidity output established by Pall Medical for the device. This is based on physical measurements against engineering design requirements, not clinical ground truth like pathology or expert consensus.

8. Sample Size for the Training Set

Not applicable. This device is a hardware accessory with heating and humidifying functions; it is not software or an AI algorithm that requires a "training set" in the computational sense.

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

Not applicable, as there is no training set for this device.

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The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with CO2

The Laparoshield Conditioned Insufflation Set consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a temperature control unit integrated into the power supply component of the device. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report with explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implied by the performance characteristics of the predicate device, and the "device performance" is stated in qualitative terms.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of devices or experimental runs. The text mentions "Testing was performed to evaluate the flow rate, temperature and humidity at two different per minute average CO2 flow rates." This indicates at least two flow rate conditions were tested, but not the number of units tested or repetitions.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal to Pall Medical, the manufacturer. The study is retrospective in the sense that it's a verification and validation study conducted by the manufacturer before submission for market clearance, rather than a prospective clinical trial on human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. This type of device (a gas conditioning set) does not typically involve expert review for "ground truth" in the same way an imaging AI algorithm might. The performance criteria (flow, temperature, humidity) are objectively measurable physical properties.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" for the performance metrics (flow rate, temperature, humidity) is established by direct physical measurement using calibrated equipment, not by subjective expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device aims to assist or improve their performance. The Laparoshield Conditioned Insufflation Set is a device accessory that performs physical conditioning of gas, not a diagnostic tool for human interpretation.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device. This device is a mechanical/electrical accessory that operates independently to condition gas. Its performance is inherent to its design and function, not dependent on an algorithm interpreting data. The performance testing described (flow rate, temperature, humidity) is its standalone performance without human intervention in the conditioning process itself.

7. Type of Ground Truth Used:

• Ground Truth Type: The ground truth for this device's performance is based on objective physical measurements of flow rate, temperature, and humidity, presumably against established engineering specifications or industry standards for optimal insufflation gas conditioning.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a hardware device with defined physical characteristics.

9. How Ground Truth for Training Set was Established:

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.

Both the Ultipor and Zefon consist of a patient kit and a machine kit. The components of the both Ultipor's and Zefon's patient kits are: (1) the BSF; (2) face mask; and (3) mask elbow. The components of both Ultipor's and Zefon's machine kit are: (1) the reservoir bag; (2) expiratory tubing; and (3) inspiratory tubing. Ultipor and Zefon both have a gas monitoring line; this line is a component of Ultipor's machine kit and Zefon's patient kit. Both devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).

In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits.

The provided text does not contain detailed information about specific acceptance criteria and a study proving device performance in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a medical device (Pall Ultipor Anesthesia Breathing Circuit System with Bacterial System filter) seeking clearance based on substantial equivalence to a predicate device.

However, based on the information provided, I can extract and infer some aspects.

Key Information from the Document:

The primary performance claim and, therefore, implied acceptance criterion, mentioned in the "Indications" and "Technological Characteristics" sections, is:

• "The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%."

The document states "The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use." This implies a study was conducted to demonstrate this, but no specifics about the study design, sample size, or results are provided in this summary.

Attempting to answer your questions based only on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

   • Sample size: Not specified.
   • Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "The 510(k) includes data," implying internal testing rather than external or clinical data.

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

   • Not applicable/Not specified. This device is a physical breathing circuit with a filter, not an AI/ML algorithm requiring expert interpretation for ground truth. Performance would be assessed through laboratory testing, e.g., microbial challenge testing for filter efficiency.

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

   • Not applicable/Not specified. This is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device.

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/ML device, so an MRMC study is not relevant. The substantial equivalence argument is based on similar physical components and performance claims to a predicate device, not on assistance to human readers.

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

   • Not applicable. This is not an AI/ML algorithm. The performance of the filter (99.999% efficiency) would be a standalone measurement.

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

   • For the 99.999% filtration efficiency claim, the ground truth would typically be established through laboratory testing, likely using standardized methods for microbial challenge or particle filtration efficiency, with the results empirically measured against established criteria.
   • For the durability of the gas monitoring line, it would be engineering or functional testing to ensure it withstands 24-hour/multiple use conditions.

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. This is not an AI/ML device.

In summary: The provided document is a 510(k) summary for a physical medical device. It makes a performance claim regarding bacterial/viral filtration efficiency and mentions data supporting the durability of a gas monitoring line. However, it does not detail the specifics of any studies (like sample sizes, methods for ground truth, or expert involvement) as would be typical for an AI/ML device submission. The substantial equivalence argument relies on comparing the device's characteristics and performance to an already cleared predicate device, rather than providing extensive de novo study details in this summary.

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The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).

Pall Laparoscopic Smoke Filtration System

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study that proves a device meets such criteria. The letter acknowledges a device, states its regulatory class, and grants permission to market it, but it does not detail any performance studies.

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Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrolit existing dental waterlines.

Pall Medical's Dental Unit Waterline Filtration system with Air Water Syringe Housing and Filtration Membrane. The system consists of reusable filter housings and disposable filter elements.

Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving device performance.

The document is an FDA 510(k) clearance letter for the "Pall Dental Filtration System with Air Water Syringe Housing and Filter Membrane." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

However, the letter does not include any technical details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer the specific questions about the study design, as this information is absent from the provided text.

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Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retro: it existing dental waterlines.

Pall Medical's Dental Unit Waterline Filtration System with Inline Handpiece Housing and Filtration Membrane

This document is a 510(k) clearance letter from the FDA for a medical device called "Pall Dental Filtration System with Inline Handpiece Housing and Filter Membrane." This type of document is a regulatory approval, not a scientific study report.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, and training sets is not available in the provided text.

The document primarily states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain the detailed study data that would typically be found in a scientific publication or a premarket approval (PMA) application.

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