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AirFit F20 Mask System:

The AirFit F20 mask has two product variants:

• AirFit F20 mask is intended for single-patent reuse in the home environment.
• AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

AirFit F20 NM Mask System:

The AirFit F20 Non Magnetic mask has two product variants:

• The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
• The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.

The AirFit F20 mask system has two product variants:

• AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.

The AirFit F20 NM mask system has two product variants:

• AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.

The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.

The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.

The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.

Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.

Here's an attempt to extract the relevant information and address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.

Here's a summary derived from the comparison table (Pages 9-12 of the provided document):

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OSPREY Midline Closed IV Catheter System (OspreyEDC) is an intravascular catheter intended to be inserted into the patient’s vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The OSPREY Midline Closed IV Catheter System (OspreyEDC) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.

The OSPREY Midline Closed IV Catheter System (OspreyEDC) has a usable (deployed) catheter length of 3.25 inches. The device is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (

The provided FDA 510(k) clearance letter and summary discuss a medical device, the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20), and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing detailed acceptance criteria and a study proving those criteria are met for an AI/software-as-a-medical-device (SaMD).

Here's an analysis based on the provided text, highlighting what information is available and what is not available regarding the specific questions about acceptance criteria and a study proving device performance in the context of AI/SaMD:

Summary of Acceptance Criteria and Device Performance (Based on provided document):

The document does not present explicit "acceptance criteria" in the format one might expect for a software or AI product's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence by comparing the new device's technological characteristics and performance outcomes against a predicate device and relevant industry standards. The implicit "acceptance criteria" are that the new device performs at least as well as the predicate and meets established safety and performance standards.

Since this is a filing for a physical medical device (an IV catheter system) and not an AI/SaMD, many of the requested items related to AI model validation, such as test sets, ground truth establishment, expert adjudication, and training set details, are not applicable and therefore not present in the document.

Here's a breakdown of the specific points from your request:

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

   • Available in document: Yes, a comparison table (Table VII - I) is provided on pages 7-11, outlining attributes of the subject device (OSPREY Midline Closed IV Catheter System) against the predicate device. This indirectly serves as acceptance criteria in the context of substantial equivalence for a physical medical device. The "Performance" section on page 12 also lists standards adhered to via bench testing.
   • Not explicitly stated as AI/SaMD performance metrics (e.g., sensitivity, specificity): This is a hardware device, so these metrics are not relevant or provided.

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/Not available in document: This information is typically for AI/SaMD. For a physical device, testing involves bench tests and biocompatibility, not data sets in the AI sense. No specific "sample sizes" for clinical data or data provenance are mentioned, as clinical studies in the AI context were not conducted or required for this type of device and submission. The document mentions "bench tests," but doesn't specify sample sizes for those tests.

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/Not available in document: "Ground truth" in this context refers to clinical data labeling for AI. For a physical device like a catheter, "ground truth" is established through engineering and biocompatibility standards, and performance against those standards is evaluated by engineers and lab personnel, not necessarily "experts" in the clinical decision-making sense with specific experience levels for data labeling.

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

   • Not applicable/Not available in document: This is relevant for clinical data labeling for AI performance evaluation.

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/Not available in document: This is entirely for AI-assisted diagnostic devices. This is a standalone physical medical device.

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

   • Not applicable/Not available in document: This pertains to AI algorithm performance.

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

   • Not applicable/Not available in document: As mentioned, for this physical device, "ground truth" is based on adherence to recognized industry standards (ISO, ASTM, USP) and established engineering principles and test methods (e.g., flow rate measurement, physical dimensions, material properties, biocompatibility assays).

8. The sample size for the training set

   • Not applicable/Not available in document: This applies to AI models.

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

   • Not applicable/Not available in document: This applies to AI models.

In conclusion, the provided document is a standard 510(k) submission for a physical medical device. It successfully demonstrates substantial equivalence to a predicate device by comparing design, materials, indications for use, and performance based on engineering bench tests and adherence to recognized international standards for medical devices. The specific questions you asked are geared towards the evaluation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), which is not the subject of this 510(k) clearance letter.

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Powered Muscle Stimulator (Model name:MagGraver F200) is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
  · Strengthening, Toning and Firming of buttocks.

Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle.
The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators.
The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system.
There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator.
The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted.

I'm sorry, but this document does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter and summary for a Powered Muscle Stimulator (MagGraver F200). While it addresses device safety and effectiveness in comparison to a predicate device, it does not describe:

1. Acceptance criteria for an AI/algorithm-based device and reported performance against those criteria. This device is a physical electromedical device, not an AI/algorithm-based diagnostic or therapeutic tool.
2. Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the validation of AI/ML models, which is not the subject of this document.
3. Ground truth establishment or training set details. Again, these relate to AI/ML model development and validation.

The primary performance data presented relates to non-clinical bench testing of the magnetic field intensity and pulse characteristics, and compliance with general medical device standards (e.g., IEC 60601-1 for safety). There is no mention of a performance study proving the device meets acceptance criteria related to AI/ML.

Therefore, I cannot extract the requested information from the provided text.

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Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in three (3) sizes. The sizes are differentiated by housing size, fiber count per bundle, and effective membrane surface area.

Optiflux dialyzers are high-flux, sterile devices designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a dialysis machine equipped with ultrafiltration control. During treatment, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer contains a semi-permeable membrane that allows for diffusion and/or convection to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate or filtrate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The provided text does not contain information about an AI/algorithm-based device. The device described, Optiflux® Series of Dialyzers, is a medical device for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration. Therefore, this document cannot fulfill the request to provide details about acceptance criteria and study proving device meets acceptance criteria for an AI/algorithm-based device.

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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:

• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face.

The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

This document is an FDA 510(k) clearance letter for a medical device called AirFit F20, a non-invasive accessory for positive airway pressure (PAP) devices. It does not contain information about an AI/ML device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as the provided text pertains to a traditional medical device submission and does not involve AI or ML.

The document discusses the substantial equivalence of the AirFit F20 to a previously cleared predicate device (AirFit F20 (K153563)) based on:

• Intended Use: Same
• Operating Principle: Same
• Design and Materials: Similar
• Performance: Similar pressure-flow characteristics and flow impedance
• Operating Environments: Same (home and hospital/institution)
• Manufacturing Processes: Similar

The main differences from the predicate device relate to reprocessing claims for multi-patient reuse and material changes to certain components. Non-clinical data validation testing was conducted to demonstrate that these changes do not raise new questions of safety or effectiveness. This validation included:

• Bioburden efficacy tests
• Performance tests (visual inspection, total mask flow, AAV activation/deactivation, assembly integrity, mask-to-headgear connections) before and after reprocessing
• Residual toxicity tests
• Biocompatibility tests for material changes (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute systemic toxicity, Material-mediated Pyrogenicity, Implantation, Leachables testing)

In summary, the provided text describes a 510(k) clearance for a non-AI medical device and therefore does not contain the information needed to answer your specific questions about AI acceptance criteria and study details.

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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

The provided document is a 510(k) summary for the ResMed AirFit F20, a non-invasive accessory for CPAP/bilevel systems. It focuses on demonstrating substantial equivalence to a predicate device (Quattro Air K123979) rather than presenting a study to prove acceptance criteria for a new, unique device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not explicitly detailed as one might find in a study specifically designed to establish novel performance claims.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific acceptance criteria values alongside numerical performance results for the AirFit F20. Instead, it states that the device was designed and tested in accordance with ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories, and that testing confirmed the new device met "predetermined acceptance criteria" and its performance is "substantially equivalent" to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. The testing appears to be primarily bench/non-clinical and biocompatibility. For bench testing of physical characteristics like flow, rebreathing, and resistance, samples would typically consist of a certain number of manufactured units of the AirFit F20. The specific number is not provided.
• Data Provenance: The testing was non-clinical (bench testing) and focused on material and functional performance. It does not involve human patient data in the context of clinical outcomes. The manufacturer, ResMed Ltd., is based in Australia, and the submission was made to the US FDA.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (e.g., CO2 rebreathing, flow resistance) is established by measurement against predefined engineering specifications and international standards (like ISO 17510-2). These are objective physical measurements, not subjective expert interpretations that require "ground truth" establishment by multiple experts with specific qualifications like radiologists.

4. Adjudication Method for the Test Set

• Not applicable. Since the tests are objective physical measurements against standards and predicate performance, there is no need for expert adjudication.

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

• No. The document explicitly states: "Clinical data was not relied upon to demonstrate substantial equivalence to the predicate device. Bench testing demonstrates that the new AirFit F20 device performs in an equivalent manner and is as safe and as effective as the predicate device." MRMC studies apply to imaging or diagnostic devices where human readers interpret results, which is not the case for this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

• Yes, indirectly. The non-clinical data presented (CO2 rebreathing, AAV performance, total mask flow, flow resistance, through impedance, mechanical integrity, biocompatibility) represents testing of the device's inherent physical and functional performance, essentially "standalone" in a bench setting without human interaction influencing the core functional measurements. However, it's not an "algorithm" in the typical sense for AI, but rather the performance of the physical mask.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is based on:
  • International Standards: Specifically, ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories.
  • Engineering Specifications: Predetermined acceptance criteria derived from the standard and design requirements.
  • Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate device (Quattro Air (K123979)).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (mask), not an AI/algorithm-based diagnostic system that requires a "training set" in the machine learning sense.

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

• Not applicable. As above, there is no AI training set for this device.

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The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

The medical device described in the 510(k) summary is a bone cement called F20, intended for use in vertebroplasty and kyphoplasty procedures to fix pathological fractures of the vertebral body.

Here's an analysis of the acceptance criteria and study information provided in the document:

This document describes a non-clinical study for device F20 as depicted in the 510(k) summary provided.

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

The F20 bone cement’s performance was evaluated against the standards outlined in ISO 5833 "Implants for surgery - acrylic resin cements". The acceptance criteria are implicitly defined by compliance with this standard and similarity to predicate devices.

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for compressive strength testing). It only states that tests were "conducted."

The data provenance is from non-clinical laboratory testing conducted by Teknimed SAS, the manufacturer, in France. The specific nature of the data is experimental results from material science and mechanical engineering tests.

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

This information is not applicable as there was no clinical study. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards (ISO 5833) and the performance characteristics of the predicate devices. The experts involved would be the engineers and scientists conducting these tests, but their number and qualifications are not specified.

4. Adjudication method for the test set

This information is not applicable as there was no clinical study involving subjective interpretation. The assessment was based on objective measurements against ISO 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone cement, not an AI-assisted diagnostic tool.

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

No, this is not an AI algorithm. The performance evaluation was of the physical and chemical properties of the bone cement in a standalone non-clinical setting.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was based on:

• Established scientific and engineering standards: Specifically ISO 5833 "Implants for surgery - acrylic resin cements."
• Performance characteristics of legally marketed predicate devices: Vertecem (K090435), Opacity+ (K080873), and Spine-Fix® (K045593). The F20 was shown to have similar properties to these predicates.

8. The sample size for the training set

This information is not applicable as this is not a machine learning or AI device. There is no concept of a "training set" for the evaluation of a bone cement's physical and chemical properties.

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

This information is not applicable as this is not a machine learning or AI device.

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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. ImmunoCAP Specific IgE is to be used with the instruments ImmunoCAP 100, ImmunoCAP 250 and ImmunoCAP 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

The safety and effectiveness of the cleared device ImmunoCAP Specific IgE system for the determination of specific IgE antibodies have been established in previous 510(k) submissions. This submission covers the update of ImmunoCAP Allergen f20, Almond. No changes are made to the Intended Use or in the Indications for Use statements.

The updated version of ImmunoCAP Allergen f20, Almond was verified in a comparison study between the currently cleared and the updated ImmunoCAP Allergen f20, Almond. In the comparison study clinical and positive samples, as well as samples from healthy, non-atopic donors were used. Inhibition studies verified the immunological specificity of almond specific IgE antibody binding.

The provided text describes the update of the ImmunoCAP Allergen f20, Almond device, which is an in vitro quantitative assay for measuring allergen specific IgE. The study focuses on demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, the study's goal was to demonstrate substantial equivalence to an existing predicate device (UniCAP 100 / ImmunoCAP Specific IgE, K962274 and K051218). The reported performance is summarized as follows:

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

• Sample Size: The document does not specify an exact number for the sample size. It states that "clinical and positive samples, as well as samples from healthy, non-atopic donors were used."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "clinical and positive samples" and "healthy, non-atopic donors," suggesting human samples were used in a clinical context.

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

This information is not provided in the document. The study is a comparison between two in-vitro diagnostic devices, not a study involving expert human interpretation of images or clinical assessments to establish ground truth in the traditional sense for diagnostic imaging AI. The "ground truth" for this type of device would typically be derived from the established measurement of IgE antibodies in the samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the study compares the analytical performance of two in-vitro diagnostic assays, there isn't a need for an adjudication method in the way it's used for interpreting ambiguous human assessments or imaging results. The comparison would involve statistical methods to assess agreement and correlation between the two assays.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. The device described here is an automated in-vitro quantitative assay,
not an AI-assisted diagnostic tool for human readers.

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

Yes, the ImmunoCAP Allergen f20, Almond device operates as a standalone algorithm/device. It is an "in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma" utilizing instruments like ImmunoCAP 100, 250, and 1000, which "process all steps of the assay and print results automatically after the assay is completed." This indicates an automated system without direct human-in-the-loop performance during the assay itself.

7. The Type of Ground Truth Used

The ground truth is implied to be the established IgE levels in the patient and control samples. Since the study is a comparison between a new version of the assay and a previously cleared version, the existing, cleared assay's results would serve as a reference or a highly correlated comparator. For "inhibition studies," the concept of "ground truth" refers to the known immunological principle of specific binding and its inhibition.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the context of this device update. ImmunoCAP systems are based on established immunoassay principles, not typically on machine learning models that require distinct "training sets" in the way AI algorithms do. The "development" of the reagent would involve biochemical optimization, not machine learning training.

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

This information is not provided and is likely not applicable for the same reasons mentioned in point 8.

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Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.

The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.

This document describes a 510(k) submission for Interlectric Bili Blue F20T12/BBY and F40T12/BBY fluorescent lamps, used for neonatal phototherapy. It is a submission for a new device that directly compares itself to a predicate device (Philips Special Blue) to establish substantial equivalence.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for a medical device. Instead, the evaluation focuses on comparison testing of the new lamps against the predicate lamps. The "sample" here refers to the actual manufactured lamps of the new device and the predicate device that underwent testing. The document does not provide the exact number of lamps tested.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" because this is a technical comparison of physical devices, not a clinical study involving human subjects or patient data. The testing would have been conducted on the manufactured lamps themselves.

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

This information is not applicable to this type of device submission. Since it's a technical comparison of light bulbs against a predicate device and ANSI standards, there isn't a "ground truth" established by medical experts for a "test set" of patient data. The ground truth would be the established ANSI standards and the technical specifications of the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. There's no clinical "test set" requiring adjudication by experts. The comparison testing would involve objective measurements of physical properties (spectral output, UV radiation, dimensional/electrical characteristics) against defined standards and predicate device performance.

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

This is not applicable. This device is a fluorescent lamp, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

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

This is not applicable. This device is a physical light source, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is based on:

• Established Clinical Practice: The acceptance that "Phototherapy for treating Hyperbilirubinemia in newborn infants is a well-established clinical practice" and "Exposure to light from blue fluorescent lamps for such treatment was adopted in the United States back in the 1970's" serves as a foundational "ground truth" for the intended use.
• Predicate Device Specifications: The performance characteristics (spectral output, UV safety, etc.) of the Philips Special Blue predicate device serve as a benchmark.
• ANSI Specifications: Adherence to ANSI C78.2-1978 and ANSI C78.1-1991 for dimensional and electrical characteristics serves as a regulatory and industry "ground truth."

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

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Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis.

The Optiflux F20NR , F18NR , and F16NR are e-beam sterilized, low-flux versions of the Optifiux 200NR. The technological characteristics of the Optiflux F20NR®, F18NR°, and F16NR° are equivalent to those of the Optiflux 200NR and Hemoflow F7NR8 and raise no new types of safety or effectiveness questions.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for hemodialyzers, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results in the format requested.

Specifically, the document does NOT contain:

• A table of acceptance criteria and reported device performance.
• Information on the sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Information on Multi Reader Multi Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• The type or establishment method of ground truth.

The document states that "testing of the Optiflux F20NR , F18NR , and F16NR indicates that they are safe and effective for their intended use," but it does not elaborate on the specific tests, their acceptance criteria, or the detailed results.

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