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The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.

The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.

The provided text describes the regulatory clearance for the "ProntoPump Sterile Tube Set" (K200893) and its substantial equivalence to a predicate device (K062909). However, it does not explicitly state "acceptance criteria" for performance in a table format with specific quantitative goals and reported device performance against those goals for the K200893 device. Instead, it compares the technological characteristics and performance of the subject device to the predicate in a qualitative manner and mentions general ISO and ASTM standards to which the device was tested.

The closest information relating to performance criteria and reported performance is about Volume Accuracy and Minimum Flow Rate, which are compared to the predicate device.

Here's an attempt to create the requested table based on the limited quantitative performance data provided, and then address the other points.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit "acceptance criteria" with pass/fail thresholds are not clearly stated for the K200893 device. Instead, the document compares its performance characteristics to the predicate device. The information below is extracted from the "Comparison of Technological Characteristics with The Predicate Device" table and the "Differences Compared to Predicate Device / Substantial Equivalence Discussion" section.

Note: The document states "Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness." This indicates that the "reported device performance" for volume accuracy, while different, was deemed acceptable for substantial equivalence.

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

The document refers to "Bench Testing" against various ISO and ASTM standards. However, it does not provide any specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing results, as these are laboratory/bench tests, not clinical studies involving patient data.

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

N/A - This submission is for a medical device (sterile tube set) and relies on bench testing against established engineering and safety standards (ISO, ASTM, USP). There are no human experts involved in establishing a "ground truth" in the context of clinical interpretation or diagnostic accuracy for this type of device. The ground truth is defined by the objective metrics and criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

N/A - As this is bench testing against objective engineering and safety standards, no adjudication method (like 2+1, 3+1 consensus) is applicable or mentioned. The results are typically measured against the specified tolerances within the standards.

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

N/A - This document describes a syringe pump accessory (sterile tube set), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant.

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

N/A - This device is a physical medical device (tube set) used in conjunction with a pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the requirements and specifications within recognized international standards for medical devices, particularly those related to infusion equipment, sterilization, packaging, and biocompatibility. These include:

• ISO 8536-4:2019 (Infusion equipment)
• ASTM D4169-16 (Shipping Containers)
• ISO 80369-7:2016 (Small-bore connectors)
• ISO 10993-1:2018 (Biocompatibility)
• USP 788 (Particulate Matter)
• ISO 11607-1:2019 & ISO 11607-2:2019 (Packaging)
• ISO 11137-1:2006 & ISO 11137-2:2013 (Radiation Sterilization)
• The established performance characteristics of the legally marketed predicate device (K062909) also serve as a comparative ground truth for evaluating substantial equivalence.

8. The Sample Size for the Training Set

N/A - This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" for this submission.

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

N/A - As there is no training set for a physical device, this question is not applicable.

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OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, and minor burns.

Professional Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management.

Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

The provided text is a 510(k) Substantial Equivalence Determination letter from the FDA for a wound gel called Prontosan Wound Gel. This document states that the device is "substantially equivalent" to a legally marketed predicate device (Prontosan Wound Gel, K101882) and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The 510(k) process for this device, in particular, focuses on the manufacturer's claim that no changes have been made to the device design, packaging, manufacturing process, indications for use or the intended use. The submission is purely for labeling content changes.

Therefore, I cannot provide the requested information from this document. The document explicitly states:

• No new studies were conducted or required to demonstrate performance. The substantial equivalence is based on the device being identical to a previously cleared predicate device.
• No acceptance criteria are mentioned because the device's performance is assumed to be equivalent to the predicate, which would have already met its own performance criteria when it was initially cleared.

In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

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Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

Wound Irrigation Solution is a clear. clear. colorless liquid containing Prontosan undecylenamidopropyl betaine, polyaminopropyl biguanide, sodium hydroxide and purified water. The solution is aseptically filled using a blow fill seal process into low density polyethylene 40 mL ampoules; 350 mL squeeze bottles and 1000 mL bottles with screw caps. Prontosan Wound Irrigation Solution is used for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt and debris. The Prontosan Wound Irrigation Solution Adaptor is a component that may be screwed on to the current Prontosan Wound Irrigation Solution containers (350 ml and 1000 ml bottles) and provides alternate spout geometry for which to access the solution inside the bottle. It is provided in sterile form, labeled for single patient use only.

The provided document is a 510(k) premarket notification for a medical device called "Prontosan Wound Irrigation Solution." This document pertains to regulatory approval rather than a scientific study on the device's performance against detailed acceptance criteria in a clinical or standalone setting.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "The subject device and the predicate device are exactly the same. No changes have been made to the device, manufacturing process, the packaging process or the intended use. The modification subject to this 510(k) is for labeling content only." (Page 4)
• "No new non-clinical testing has been performed for this submission. The changes to the labeling are test results from testing previously performed on this product and submitted to the FDA in a prior submission." (Page 4)

This indicates that the current submission is not based on new performance data or a new study, but rather a labeling change for a substantially equivalent device. Consequently, none of the requested study details (sample size, ground truth, expert qualifications, MRMC, standalone performance, etc.) are present in this document.

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Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.

Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.

The document describes the Prontosan® Wound Gel X, a wound dressing, and its substantial equivalence to predicate devices. It mentions that performance testing was conducted to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific details on the sample sizes used for the biocompatibility, USP , or Strike Through Barrier tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

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

This information is not provided. The testing described appears to be laboratory-based performance and biocompatibility testing, not studies requiring expert interpretation of results to establish ground truth in the context of medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve adjudication as it's not a study where human readers or algorithms interpret data against a ground truth.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through biocompatibility and performance testing, not on comparing human reader performance with and without AI assistance.

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

This is not applicable as Prontosan® Wound Gel X is a wound dressing, not an algorithm or AI device. The studies mentioned are traditional medical device performance tests.

7. Type of Ground Truth Used

The ground truth for the performance tests (Biocompatibility, USP , Strike Through Barrier Test) would be established by the defined standards and protocols of these specific tests. For example, for biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1. For USP , it likely refers to antimicrobial effectiveness testing against predefined microorganisms and reduction criteria.

8. Sample Size for the Training Set

This is not applicable and not provided. Prontosan® Wound Gel X is a medical device (wound dressing), not a machine learning model, so there is no "training set."

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

This is not applicable for the same reason as above; there is no training set for this type of medical device.

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The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, and ambulatory surgery centers).

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories include the noninvasive technology spot check of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device. This submission introduces two new sensor sizes (medium and small) and an optional Maximum Sensitivity Mode that extends the detection range for SpHb.

Here's analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

The provided text details multiple performance validations for SpO2, SpHb, and Pulse Rate accuracy.

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

   • SpO2 Accuracy: "human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation." No specific number of volunteers given. The study involved inducing hypoxia.
   • SpHb Accuracy: "with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
   • Pulse Rate Accuracy: "on healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
   • Data Provenance: The studies were conducted with "human blood" and "volunteers/patients," suggesting prospective clinical studies. The country of origin is not explicitly stated, but it's likely the US given the FDA submission.

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

   • SpO2: Ground truth was established by "a laboratory CO-Oximeter and ECG monitor." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
   • SpHb: Ground truth was established by "a laboratory CO-Oximeter." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
   • Pulse Rate: Ground truth was established by an unspecified method; often this is also derived from ECG or another reference monitor. No human experts are mentioned.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by reference devices (laboratory CO-Oximeter, ECG monitor), not through human expert adjudication.

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 MRMC comparative effectiveness study was conducted. This device is an oximeter, which provides direct measurements (SpO2, SpHb, Pulse Rate) and does not involve human "readers" interpreting images or data that an AI might assist with.

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

   • Yes, the performance data presented is for the device (algorithm and sensor) operating in a standalone capacity. The accuracy metrics (rms of SpO2, Pulse Rate, SpHb) are direct measurements of the device's performance against reference standards. It's a "spot check" device, meaning it provides a reading without continuous human interaction for interpretation beyond reading the display.

6. The type of ground truth used:

   • Instrumentation-based ground truth:
     • For SpO2, a "laboratory CO-Oximeter and ECG monitor" served as the reference.
     • For SpHb, a "laboratory CO-Oximeter" served as the reference.
     • For Pulse Rate, accuracy was validated, but the specific reference ground truth instrument is not explicitly named, though usually, an ECG monitor would be used.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" or its sample size. Oximeters typically use empirical models and calibrations developed from extensive physiological data, rather than a distinct "training set" in the machine learning sense for each submission. This submission focuses on validation of the device's accuracy.

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

   • As no specific "training set" is described, the method for establishing its ground truth is not provided. The device's underlying technology is stated to be the "same" as the predicate device, implying that the foundational calibration and algorithms were likely established in prior, more extensive studies. The current submission focuses on validating the performance of new sensor sizes and an extended sensitivity mode against established reference methods.

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Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

The subject device of this submission is Prontosan® Wound Irrigation Solution indicated for over-the-counter use. Prontosan Wound Irrigation Solution is currently cleared in a prescription use only version. Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps. The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prontosan® Wound Irrigation Solution:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes an Antimicrobial Effectiveness Testing study.

• Test Set Organisms: The study used a standard panel of Gram-positive and Gram-negative bacteria, and fungi.
  • Bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus aureus, Vancomycin-resistant enterococcus, Serratia marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis, Enterobacter cloacae.
  • Fungi: Candida albicans, Aspergillus brasilienis (niger).
• Data Provenance: Not explicitly stated, but it's an in-vitro laboratory test conducted according to USP standards. This is generally considered a controlled laboratory environment rather than patient data from a specific country, and it's a prospective test designed to evaluate the product's preservative efficacy.

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

Not applicable. The study is a laboratory-based antimicrobial effectiveness test, not one requiring expert human interpretation of medical images or clinical outcomes. The "ground truth" is defined by the objective measurement of microbial growth inhibition according to USP protocol.

4. Adjudication Method for the Test Set:

Not applicable. This was a laboratory test with objective measurements based on USP methodology, not requiring adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a wound irrigation solution, not for an AI-powered diagnostic or interpretive device.

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

No. This concept is not applicable to a wound irrigation solution. The "performance" here refers to the chemical and preservative efficacy of the solution itself, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was objective laboratory measurements based on a validated standard (USP ) for antimicrobial effectiveness. This involves inoculating the product with specific microorganisms and observing their growth or inhibition over time, rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set:

Not applicable. This device is a wound irrigation solution, not an AI or machine learning model that requires a training set. The "training set" concept is irrelevant here.

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

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

Summary of the Study:

The study described is an Antimicrobial Effectiveness Testing conducted according to USP category 2. This non-clinical test evaluated the ability of the Prontosan® Wound Irrigation Solution (intended for over-the-counter use) to inhibit the growth of common bacterial and fungal microorganisms within the product itself. The listed organisms represent typical pathogens found in wound beds. The study concluded that the device was effective in inhibiting microbial growth, thereby demonstrating its stability and preservative efficacy. This testing was performed to support the substantial equivalence claim, particularly regarding the solution's identity (formulation and processing) with its prescription-use predicate and its similarity in active ingredients to Prontosan® Wound Gel.

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The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The Pronto V4 extraction catheter (Pronto) is a dual lumen rapid exchange catheter that has a working length of approximately 138 cm and is packaged with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires ≤0.014 inches in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included 30 mL syringes through the extension line and stopcock. The catheter has a stiff proximal region and a flexible distal region. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The catheter contains a radiopaque marker band located approximately 2 mm from the distal tip. The distal 18 cm of the catheter has a hydrophilic coating to enhance deliverability to the target vasculature. The device has positioning marks located at 95 cm and 105 cm from the distal tip, respectively. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of catheter to the included extension line, stopcock, and 30 mL syringes. A filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombus.

The provided text does not describe a study involving "acceptance criteria" and "reported device performance" in the typical sense of a clinical or comparative effectiveness study. Instead, it describes a medical device, the Pronto V4 extraction catheter, that has undergone verification testing against specified acceptance criteria to demonstrate substantial equivalence to a predicate device for FDA clearance.

Therefore, many of the requested fields cannot be directly answered from the provided text because they pertain to clinical study methodologies that are not present.

However, I can extract information related to the device verification and the "acceptance criteria" as described in the document.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

The document states: "Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions."

While specific numerical acceptance criteria (e.g., "tensile strength > X N") and the exact reported values for each test are not provided, the document lists the categories of tests performed. The "reported device performance" is implicitly stated as "met the specified acceptance criteria" for all tests.

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: Not specified for any of the verification tests.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical data.

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. The "ground truth" for these engineering/biomaterial tests would be the established scientific and engineering principles and standards against which the device performance is measured, not expert clinical consensus as might be the case for diagnostic imaging.

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

• Not Applicable. This concept applies to human expert review in diagnostic assessments, not to bench testing of a device's physical properties or biocompatibility. The tests would be performed and evaluated according to predefined protocols.

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 document describes the clearance of a mechanical medical device (extraction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

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

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

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

• The "ground truth" in this context refers to established engineering standards, material science principles, and biological safety guidelines (e.g., ISO standards for biocompatibility) that define acceptable performance for each test. For example, for "Tensile," the ground truth would be a minimum tensile strength required for safe operation, likely derived from clinical use cases and engineering specifications.

8. The sample size for the training set

• Not Applicable. This document describes verification testing for a physical medical device, not a machine learning model. There is no "training set."

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

• Not Applicable. See response to #8.

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OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns. Professional Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

The provided text describes a 510(k) submission for the Prontosan® Wound Gel. The submission focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through in-vitro testing for preservative effectiveness and by referencing prior biocompatibility and functional testing. It is not a study about an AI-powered device, medical imaging, or any diagnostic/prognostic tool that would typically involve acceptance criteria for algorithms, human readers, or ground truth establishment as outlined in your request.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria for a device's performance, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this submission. This document pertains to a medical device (wound gel) and its regulatory clearance process, which relies on demonstrating safety and effectiveness, often through comparison to existing products, rather than validating an algorithm's performance against clinical endpoints or expert interpretations.

Here's a breakdown of why each point is not fully addressable from the given text:

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

   • Not Applicable. The document describes "in-vitro testing conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel." However, specific acceptance criteria (e.g., percentage reduction in microbial growth, specific performance metrics) and detailed results are not provided in this 510(k) summary. The summary concludes that "The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device," implying that any set criteria were met.

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

   • Not Applicable. This information is not provided. The testing mentioned is "in-vitro testing" for preservative effectiveness, not a clinical trial or a test of an algorithm on a dataset.

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

   • Not Applicable. There is no "ground truth" in the context of expert interpretation, as this is not a diagnostic device or an AI algorithm relying on human labels. The testing is laboratory-based (in-vitro).

4. Adjudication method for the test set:

   • Not Applicable. No human interpretation or adjudication 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:

   • Not Applicable. This is not an AI device, and no MRMC study is mentioned.

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

   • Not Applicable. This is not an algorithm.

7. The type of ground truth used:

   • Not Applicable. The "truth" in this context would be laboratory measurements of preservative effectiveness and material properties, compared against established standards or predicate device performance. Not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/diagnostic device validation.

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. There is no training set or associated ground truth.

Summary based on the provided text:

The device, Prontosan® Wound Gel, gained 510(k) clearance (K101882) based on demonstrating substantial equivalence to predicate devices (Prontosan® Wound Gel, K090141, and Anasept® Antimicrobial Skin and Wound Gel, K073547). The primary evidence cited for this submission is:

• In-vitro testing conducted to prove the effectiveness of the preservative (0.1% w/w PHMB) in Prontosan® Wound Gel.
• The fact that Prontosan® Wound Gel (K101882) is the same product as in the original Prontosan Wound Gel submission (K090141), with the only difference being expanded indications for use.
• The biocompatibility and functional performance testing conducted on Prontosan Wound Gel in K090141 is considered applicable to K101882.

The conclusion is that this non-clinical testing demonstrates the proposed device is as safe and effective as the predicate device, thereby meeting the requirements for 510(k) clearance for its stated Indications for Use.

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The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO₂), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.

Here's an analysis of the acceptance criteria and study details for the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories, based on the provided text:

Acceptance Criteria and Device Performance

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The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories in this filing are the same as the Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories in K082052. The reason for this filing is to clarify the intended use and the labeling of the device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Specifications" in the document. The reported device performance is presented as "Accuracy" values.

Additional Specifications/Features (not directly accuracy-related):

• Display Ranges: Saturation (SpO2): 0-100%; Pulse Rate: 25-240 bpm; Total Hemoglobin (SpHb): 0-25 g/dl; Total Oxygen Concentration (SpOC): 0-35 ml/dl; Perfusion Index: 0.02-20%
• Resolution: SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl
• Operating Temperature: 41°F to +104°F (5°C to +40°C)
• Storage Temperature: -40°F to +158°F (-40°C to +70°C)
• Relative Humidity: 5% to 95% noncondensing
• Operating Altitude: 500 mbar to 1,060 mbar pressure; -1,000 ft to 18,000 ft

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

The document does not explicitly state the exact sample size for each test. However, it indicates:

• SpO2 Accuracy (No Motion): "healthy adult volunteers" (Footnote 1)
• SpO2 Accuracy (No Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 2)
• SpO2 Accuracy (Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 3)
• SpHb Accuracy: "(arterial/venous) blood from healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (Footnote 6)

The data provenance is prospective human blood studies for SpO2 and SpHb measurements, conducted on healthy adult volunteers and surgical patients. Additional testing for low perfusion and pulse rate accuracy was done via benchtop testing using simulators. The country of origin is not specified but implied to be the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

No external experts were used to establish the ground truth for the SpO2, Pulse Rate, or SpHb measurements. The ground truth was established by laboratory instruments, as detailed below.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the tests primarily involved comparison against laboratory reference instruments, not expert interpretation.

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

No MRMC comparative effectiveness study was mentioned. The device is an oximeter, not an AI for image interpretation or diagnosis requiring human-in-the-loop comparison.

6. Standalone Performance

Yes, the accuracy specifications provided are for the standalone (algorithm only) performance of the device. The listed accuracies (e.g., ± 2%, ± 3%, ± 1 g/dl) refer to the device's ability to measure physiological parameters against a reference standard.

7. Type of Ground Truth Used

The ground truth for the various measurements was established using objective, established clinical and laboratory methods:

• SpO2 Accuracy (No motion, induced hypoxia, SpHb): A laboratory CO-Oximeter was used as the reference standard.
• SpO2 Accuracy (Motion): A laboratory CO-Oximeter and ECG monitor were used as reference standards.
• Pulse Rate Accuracy: A Biotek Index 2 simulator was used as the reference standard.
• Low Perfusion SpO2 Accuracy: A Biotek Index 2 simulator and Masimo's simulator were used as reference standards.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of device (oximeter) is generally validated through accuracy studies against a reference standard, rather than a machine learning training/test set paradigm. The "development" of the device would involve calibration and algorithm refinement, but the number of samples or data points used for these internal processes is not disclosed in this regulatory submission.

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

Since no distinct training set is described for a machine learning model, the method for establishing ground truth for a "training set" is not applicable in the context of this submission. The device's underlying technology (Masimo Rainbow SET) would have been developed and calibrated using similar physiological studies and laboratory reference instruments during its initial development.

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