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The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.

The ATLAS Stim Headbox (ASHB) is a clinical headbox that allows 3rd party Macro electrode contact electrode arrays (ECoG, depth electrodes, grid array, strip array, etc.) to interface with the Neuralynx ATLAS Neurophysiology System, previously cleared in 510(k) K110967, which includes the Pegasus Software.

The ATLAS Stim Headbox is an accessory to the ATLAS Neurophysiology System (formerly known as SpikeTrax in K110967). The ATLAS Stim Headbox hardware consists of an encased amplifier and embedded firmware for generation and delivery of stimulation energy. The ATLAS Stim Headbox can deliver electrical stimulation current under the control of the associated ATLAS Stim Headbox Software which interfaces via a fiber optic ethernet communications connection.

The provided FDA 510(k) clearance letter and summary for the ATLAS Stim Headbox do not contain information about acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing (electrical safety, mechanical integrity, evoked response, electroencephalograph, and software regression).

Therefore, I cannot fulfill most of your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document primarily covers the safety and basic functional performance of the hardware and software as a medical device accessory, not its diagnostic or therapeutic accuracy for specific clinical outcomes that would require clinical studies with ground truth.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

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

The document does not present "acceptance criteria" in the sense of a clinical benchmark (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it describes compliance with recognized standards and successful completion of verification and validation tests for safety and technical performance.

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

This information is not provided as the validation performed is non-clinical (device testing against engineering specifications and international standards), not a clinical study on patient 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)

This information is not applicable/provided. The ground truth for device performance in this context is defined by international standards (e.g., IEC 60601) and engineering specifications. No clinical expert adjudication was mentioned for device functionality.

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

This information is not applicable/provided. No clinical adjudication method was mentioned for device functionality.

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

An MRMC study was not done. The device is an accessory for stimulation and recording of neural activity, not an AI-powered diagnostic tool for interpretation by human readers.

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

This is not applicable in the context of an "algorithm only" performance for a diagnostic task. The ATLAS Stim Headbox is a hardware accessory with embedded firmware and associated software, designed to be used in conjunction with other systems and by clinical professionals. It cannot operate as a stand-alone stimulator, as explicitly stated: "it cannot serve as a stand-alone stimulator."

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

The "ground truth" for the device's substantial equivalence and safety is primarily based on:

• International standards and engineering specifications: Compliance with IEC 60601 series, IEC 62304, IEC 62366.
• Functional verification: Demonstrating that the device's electrical characteristics (e.g., charge per phase, instantaneous current sum) meet safety limits and design specifications.
• Predicate device characteristics: The claim of substantial equivalence is made against the technical specifications and known performance of the predicate devices.

8. The sample size for the training set

This is not applicable/provided. The document describes a hardware device and its control software. There is no mention of "training set" in the context of machine learning for a diagnostic algorithm. Software regression testing refers to the iterative testing of the software itself against predefined functionalities and bug fixes, not the training of a model on a dataset.

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

This is not applicable/provided as there is no "training set" in the context of machine learning for a diagnostic algorithm.

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The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.

The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total.

The provided text is related to a 510(k) premarket notification for a medical device (Reusable Interface Cable 1.5 m), which is an electrosurgical accessory. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed acceptance criteria and study results for clinical efficacy or sophisticated AI performance.

Therefore, the document does not contain information relevant to:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
• Sample size used for a test set in the context of an accuracy study or provenance of data.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: A flexible, low-loss coaxial cable connecting a Creo Medical Instrument to a CROMA Electrosurgical Generator for delivering RF and/or Microwave energy. It specifies a lifetime of 20 uses.
• Intended Use/Indications for Use: Connection of compatible Creo Medical Instrument to the CROMA Electrosurgical Generator to deliver RF/Microwave energy for cutting, coagulation, and ablation of gastrointestinal tissue. This indication is stated to be the same as the predicate device, with reworded readability.
• Technological Comparison: The subject device is a reusable version of the predicate device. The conductor cable was modified for durability while maintaining identical electrical properties. Principles of operation, electrical properties, energy source, materials, dimensions, and cleaning methods are identical to the predicate.
• Non-Clinical Tests:
  • Electrical safety testing: Conducted in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
  • Performance bench testing: Conducted to establish device durability over its established lifetime for:
    • Cleaning between uses (reprocessing)
    • Rotation load
    • Cyclic load
    • Connector connection and disconnection forces.

Conclusion:

This submission is for an accessory device (cable) that facilitates the use of an electrosurgical unit. The "acceptance criteria" and "study" described are primarily related to electrical safety and physical durability/reusability of the cable, ensuring it functions as intended for its specified lifespan and remains substantially equivalent to the predicate device. It does not involve complex performance metrics or clinical studies in the context of diagnostic accuracy or AI-driven decision support.

Since the provided text does not contain the requested information about diagnostic performance, AI, or specific clinical study details as implied by the questions, I cannot populate the table or answer those specific points. The information available is about engineering and regulatory compliance testing for a reusable medical cable.

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This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.

Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).

This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).

The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.

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

• Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
• Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.

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

This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.

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

Not applicable. This device is a respiratory gas delivery interface, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.

Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.

The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.

The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.

The provided document describes a 510(k) premarket notification for the "LIFEPAK® Invasive Pressure Adapter Cable." It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general performance testing.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide the available details:

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

This information is not provided in the document. The document states "Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications." However, the specific acceptance criteria and the numerical results of these tests are not detailed.

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

This information is not provided in the document. The document only mentions "Biocompatibility Evaluation" and "Design Verification Testing" were completed.

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 document does not describe a study involving expert-established ground truth.

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

Not applicable. The document does not describe a study with adjudication.

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. The device is an adapter cable, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. The device is a physical cable, not an algorithm.

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

Not applicable. The document does not describe a study that uses ground truth in this context. The "performance data" refers to engineering and biocompatibility testing.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning algorithm that requires a training set.

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

Not applicable. The device is a physical cable, not a machine learning algorithm.

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The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

• Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
  • Similar intended use.
  • Similar indications for use.
  • Similar fundamental scientific technology.
  • No new harms or unacceptable risks.
• Study That Proves the Device Meets Acceptance Criteria:
  • Type of Study: Non-clinical studies were performed, including:
    • Bench testing.
    • Electromagnetic Compatibility (EMC) testing.
    • Software verification and validation testing.
    • Design verification and validation testing.
  • Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
  • Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
  • Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
    • Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
    • Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
    • Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

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F&P Optiflow Junior 2: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Neonates, birth up to 1 month of age, Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2+: The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants. 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2 HM Cannula: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontaneously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2+ HM Cannula: The Fisher & Paykel Healthcare Optiflow™ Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range are single-use patient interfaces that are intended to deliver heated and humidified Nasal High Flow therapy to spontaneously breathing neonates, infants and children. It is intended to be prescription-only and provided in a non-sterile state.

The F&P Optiflow Junior 2 Product Codes are OJR410 (XS), OJR414 (M), OJR416 (L) OJR416HM (L), OJR418 (XL), and OJR418HM (XL).

The F&P Optiflow Junior 2+ Product Codes are OJR520 (XXL) and OJR520HM (XXL).

Optional Kits:
Ventilator Transition Kits: The F&P Optiflow Junior 2 and 2+ Ventilator Transition Kits allow the use of the F&P Optiflow Junior 2 and F&P Optiflow Junior 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a ventilator to deliver heated and humidified nasal high flow (NHF) therapy. This kit contains the F&P Optiflow Junior 2 and 2+ cannula (subject device) and a 12F/15M Adaptor.

Blender Transition Kits: The F&P Optiflow Junior 2 and 2+ Blender Transition Kits allow the use of F&P Optifilow Junior 2 and 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a blender heated and humidified nasal high flow (NHF) therapy to spontaneously breathing patients who require breathing support. This kit contains F&P Optiflow Junior 2 and 2+ cannula (subject device), a 12F/15M Adaptor and a Pressure Relief Manifold (cleared in K173770).

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results for novel devices. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or specific effect sizes for human improvement with AI assistance are not applicable here as this is a medical device (nasal cannula) and not an AI/ML powered device.

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

The document doesn't explicitly define "acceptance criteria" against numerical targets in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through a comparison of the subject device's (F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range) characteristics and performance against a predicate device (F&P Optiflow Junior Nasal Cannula, K162553). The "acceptance" is that the device has similar technological characteristics, intended use, and performs safely and effectively as demonstrated through non-clinical testing.

Here's a table summarizing the comparison, with "Reported Device Performance" reflecting how the subject device aligns with or deviates from the predicate, implying acceptability.

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

This document describes non-clinical performance testing rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for patient data or data provenance (country of origin, retrospective/prospective) are not provided as it's not relevant to this type of submission. The "test set" would refer to the physical devices and materials tested in the various engineering and biocompatibility evaluations. These tests are conducted by the manufacturer, Fisher & Paykel Healthcare Ltd. (New Zealand).

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)

This is not applicable to a 510(k) submission for a non-AI medical device like a nasal cannula. "Ground truth" in this context would come from recognized standards, engineering specifications, and established biocompatibility principles, not from expert review of patient data.

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

This is not applicable. Adjudication methods are typically used in clinical studies for interpretation of complex diagnostic results to establish a consensus ground truth, which is not relevant for the engineering and biocompatibility tests conducted for this 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

This is not applicable. The device is a nasal cannula, not an AI-powered diagnostic or assistive tool. No human "readers" or AI assistance are involved in its primary function, and therefore, an MRMC study or effect size related to AI improvement is irrelevant.

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

This is not applicable as the device is not an algorithm or AI system.

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

For the non-clinical tests conducted, the "ground truth" is established by:

• International and National Standards: e.g., ISO and ASTM standards for dimensions, materials, biocompatibility, packaging, and shelf life.
• Engineering Specifications: Internal design specifications and performance requirements for the cannula's physical properties, leak rates, flow rates, and connection integrity.
• Risk Management Processes: Identified hazards and associated mitigations based on expected device performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a non-AI medical device submission.

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

This is not applicable as there is no "training set."

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The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.

It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery.

The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application.

The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that.

The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.

The provided text is a 510(k) Premarket Notification for the "eKuore One Wireless Electronic Interface for Stethoscope" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy, sensitivity, specificity, or other clinical efficacy metrics. Instead, the document discusses technical characteristics and regulatory compliance to demonstrate equivalence to a previously cleared device.

Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document.

Here's what can be gathered, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical performance. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and regulatory compliance.

• Reported Device Performance: The document lists technical characteristics of the eKuore One Wireless electronic interface for stethoscope and compares them to a predicate device. This is not "performance" in the sense of diagnostic accuracy or clinical outcomes.

  Elements of Comparison (as per provided text)	eKuore One Wireless electronic interface for stethoscope (Candidate Device)	Eko electronic stethoscope system (Reference Device)	Comparison
  Regulatory data
  Regulatory Class	Class II	Class II	Identical
  Device Classification name	Electronic Stethoscope	Electronic Stethoscope	Identical
  Regulation Number	21 CFR 870.1875	21 CFR 870.1875	Identical
  Classification Product code	DQD	DQD	Identical
  FDA Clearance	Pending	K151319	-
  USE
  Intended use	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Similar (Predicate also amplifies sound)
  Characteristics
  Principles of operation	Microphone & electronics for digitalization/codification, wireless (Bluetooth) to mobile.	Dispositive introduced in acoustic stethoscope, sound amplification, audio transmission to smartphone via Bluetooth.	Similar (Both acquire and transmit sound to a mobile app)
  Clinical conditions	Human body sounds related	Human body sounds related	Identical
  Use	Electronic stethoscope	Electronic stethoscope	Identical
  Compatibility	-Littmann 3M Cardiology III/IV -Littmann 3M classic II/III	-Littmann 3M Cardiology II/III -Welch Allyn Harvey Elite -ADC601 lines of analog stethoscopes	Similar (Both compatible with Littmann 3M Cardiology III)
  Prescription/OTC	Prescription use	Prescription use	Identical
  Intended for Direct Connection to Patient	No	No	Identical
  Use environment	Clinical	Clinical	Identical
  Type of users	Health-care personnel	Health-care personnel	Identical
  Target population	All types of patients	All types of patients	Identical
  Cleaning & Maintenance	Detach, alcohol wipe cleaning of eKuore One. Stethoscope cleaned between each patient.	Stethoscope and CORE cleaned between each patient. External parts with 70% isopropyl alcohol wipes.	Identical
  Technical equivalence
  Sound track transfer function	Yes	Yes	Identical
  Signal transmission for visualization	Bluetooth transmission to compatible smartphones/tablets	Bluetooth transmission to compatible smartphones/tablets	Identical
  Energy Source	Rechargeable Lithium Ion Battery	Rechargeable Lithium Ion Battery	Identical
  System required	Android and iOS	Android and iOS	Identical
  Hardware and software platforms	Mobile devices or tablets	Mobile devices or tablets	Identical
  Connections	Micro USB connector only to charge internal battery	Micro USB connector only to charge internal battery	Identical
  Frequency range	20 Hz to 2 KHz	20 Hz to 2 kHz	Identical
  Signal Input Method	Sound collected via a Transducer. MEMS	Sound waves collected via a Transducer. Electro microphone	Identical
  Audio Output Method	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Identical
  Signal Storage	Allows signal storage depending on technical features of connected device.	Allows signal storage depending on technical features of connected device.	Identical
  Performance requirements	Temp range: -20℃ to +45℃ Humidity range: 0% to 90%	The operating range is 10℃ to 40℃, and 0% to 90% relative humidity	Similar
  Biological Equivalence
  Materials	Cover: ABS and EPDM; Pushbutton: PMMA; Gasket: EPDM	Body: ABS (Acrylonitrile Butadiene Styrene).	Similar
  Contact with human tissues or body fluids	Does not contact patient's body. Attached stethoscope does.	Does not contact patient's body. Attached stethoscope does.	Identical
  Sterility	Sterility considerations are not applicable	Sterility considerations are not applicable	Identical

2. Sample size used for the test set and the data provenance: Not provided. The submission relies on non-clinical test data and comparison to a predicate device, not a clinical test set for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 document does not describe an AI device or a comparative effectiveness study. The device is a "Wireless Electronic Interface for stethoscope" which electronically filters and transfers sounds.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an electronic interface for a stethoscope, meant to be used by healthcare professionals. It's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study requiring ground truth is described.

8. The sample size for the training set: Not applicable, as no machine learning algorithm requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

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The intended use of the Box View Smart Alarm Interface (SAI). Model SA-01 is to provide an interface with physiological patient monitoring systems to forward information associated to an alarm event to a designated display device(s). For medical, near real time alarms, the BoxView Smart Alarm Interface, Model SA-01 is intended to serve as a parallel, redundant, mechanism to inform healthcare professionals of particular medical alarm events. The BoxView Smart Alarm Interface, Model SA-01 does not alter the primary medical devices and associated alarm annunciations.

The BoxView Smart Alarm Interface. Model SA-01 is intended for use as a secondary alarm notification system. It does not replace the primary alarm function on the monitor.

The BoxView Smart Alarm Interface. Model SA-01 is not intended to be used for diagnostic purposes. The Box View Smart Alarm Interface, Model SA-01 is intended for use by professional clinical personnel and relies on proper use and operation of both the communication in place at the healthcare facility and the display devices used. The BoxView Smart Alarm Interface, Model SA-01 is a software product and cannot come into physical contact with patients.

The BoxView Smart Alarm Interface (SAI), Model SA-01, is a Software Medical Device (SaMD) product intended to be located on-site in the hospital, or pre-configured off site in the 'cloud' utilizing a standard Linux operating system. The primary purpose of the BoxView Smart Alarm Interface (SAI), Model SA-01 is to act as a message integrator to forward patient monitor status and alarm event information originating from a patient monitoring network. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The BoxView Smart Alarm Interface (SAI), Model SA-01 allows caregivers to be informed of their patient's alarm conditions when they are not in the patient vicinity.

The BoxView Smart Alarm Interface (SAI), Model SA-01 is an open system that is compatible with most smart phones or computers. The BoxView Smart Alarm Interface (SAI), Model SA-01 connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The BoxView Smart Alarm Interface (SAI), Model SA-01 software acquires patient data from patient monitoring devices and allows the user to configure the system to determine which information, including alarm notifications, is delivered to which users communicators. The BoxView Smart Alarm Interface (SAI), Model SA-01 then formats the data for delivery to the display devices.

The BoxView Smart Alarm Interface (SAI), Model SA-01 system is designed to forward alarm event information as the alarms are recognized by the patient monitoring network. The system is also capable of being configured to periodically forward a patient's physiological data as well. All messaging activities are recorded by the BoxView Smart Alarm Interface (SAI), Model SA-01 providing real-time activity logging for audit trail records and reporting.

The BoxView Smart Alarm Interface (SAI), Model SA-01, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor or telemetry monitoring system.

The provided text describes the acceptance criteria and the study conducted for the BoxView Smart Alarm Interface (SAI), Model SA-01, a Software as a Medical Device (SaMD) that forwards information associated with alarm events from physiological patient monitoring systems to designated display devices.

Here's a breakdown of the requested information:

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

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

• Test Set Sample Size: The test involved simulating 250 alert/alarm messages per second from 25 concurrent alert/alarm sources. The document also mentions testing "around 400 alarm signals a second," indicating a range of simulated loads. It's a simulated environment, not real patient data.
• Data Provenance: The data used for testing was simulated. XprezzNet Simulator was used to simulate alarm messages from Spacelabs patient monitors. The testing was performed in a "simulated hospital network environment." This implies the data is synthetic and not from a specific country of origin, nor is it retrospective or prospective clinical data.

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

Not applicable. The ground truth for this device's performance testing was established by the expected behavior of the system based on its predetermined specifications (e.g., if an alarm signal matched a rule, a notification should be created and sent). It was a software functionality and performance test, not a diagnostic or clinical accuracy study requiring expert human interpretation or consensus.

4. Adjudication method for the test set

Not applicable. As noted above, this was a functional and performance test against predefined software rules and expected outputs, not a subjective assessment requiring human adjudication. The validation was done by comparing the number of sent simulated alarm signals to the number of alarm signals created in the database and checking the population of notification tables.

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 device is a "Smart Alarm Interface," a middleware that forwards alarm information. It is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with or without AI assistance is not relevant to this device's function or the tests described.

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

Yes, the performance testing described is a standalone (algorithm only) test. The "Smart Alarm Interface" (SAI) operates as a software product within a simulated environment, processing simulated alarm signals and generating notifications based on its configured rules. The test specifically validates the SAI's ability to process and respond to alarm signals, filter them, and create/send notifications, without direct human intervention in the real-time processing of signals.

7. The type of ground truth used

The ground truth used was based on the predetermined specifications and expected behavior of the Smart Alarm Interface application after processing simulated alarm signals. Specifically:

• Expected number of alarm signals created in the alarm database based on simulated input.
• Correct filtering of alarm signals based on predefined rules.
• Creation of corresponding notifications for matched alarm signals.
• Population of the "sendon" column in the notification table at the expected time.

8. The sample size for the training set

Not applicable. The document describes performance testing for a software interface, not a machine learning model that requires a training set. The BoxView Smart Alarm Interface (SAI) is a message integrator and secondary alarm notification system, indicating it follows predefined logic and rules, rather than learning from data.

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

Not applicable, as there was no training set for a machine learning model.

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The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.

The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag.

Based on the provided text, the device in question is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor.

Here's the breakdown of the acceptance criteria and study 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 explicitly state the sample size used for the test set in terms of the number of individual devices or patients. It mentions that "All testing was performed on final, finished product manufactured with the proposed modification." However, it does not specify how many units constituted this "final, finished product."

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies performed are primarily technical performance tests.

4. Adjudication Method

This information is not applicable and not provided in the document, as the studies are technical performance tests rather than clinical evaluations requiring expert adjudication.

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

No. An MRMC comparative effectiveness study was not done. The device is a temperature sensor, and the studies performed are related to its technical performance and safety, not diagnostic interpretation by human readers.

6. Standalone Performance Study

Yes, standalone performance studies were done. The document states:

• "Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change."
• "Additionally, a time response test in accordance with ISO 80601-2-56 also was performed."
• "Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device."
• "The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation."

These are all standalone tests evaluating the device's technical performance and safety characteristics.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on established engineering standards and specifications:

• Accuracy: Reference to IEC 60601-2-21, implying comparison against a calibrated temperature standard.
• Time Response: Reference to ISO 80601-2-56, implying comparison against a defined response time standard.
• Biocompatibility: Reference to ISO 10993 and FDA guidance, ensuring compliance with established biological safety benchmarks.
• Electrical Safety: Reference to IEC 60601-1 and IEC 60601-1-2, ensuring compliance with established electrical safety standards.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set and associated ground truth.

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The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.

Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.

The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.

The Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface work together for use with the Nonin Medical SenSmart Model X-100 Universal Oximetry System (Model X-100).

The Nonin Medical, Inc. Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface have undergone testing to establish substantial equivalence to predicate devices (Model 8004CA and Model 8204CA Regional Oximetry Sensors).

Here is a summary of the acceptance criteria and performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "prior clinical testing provided in K102715 is applicable for the proposed Model 8006CA sensor and Model 8006PI patient interface" because "The critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical test set data for Regional (rSO2) Accuracy testing is from the K102715 submission for the predicate Model 8004CA Sensor. The specific details of the sample size, data provenance (country of origin, retrospective/prospective), etc., for that original clinical study are not provided in this document (K190560).

The current submission (K190560) relies on "detailed device comparison, analysis and testing" and the equivalency of the critical sensor optics.

For the Functional and Safety Testing, the tests were performed on the proposed devices (Model 8006CA and Model 8006PI) and are likely prospective tests conducted specifically for this submission. The sample sizes for these engineering tests are not specified but are typically small (e.g., a few units) sufficient to demonstrate compliance with standards.

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 regional oximetry accuracy is derived from clinical testing, but the specifics of expert involvement in establishing ground truth (e.g., from an arterial blood gas reference for SpO2) are not detailed within this 510(k) summary. It refers back to a previous submission (K102715).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is an oximeter, which provides a direct measurement, not an interpretative tool that requires human readers.

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

Yes, the functional, safety, and performance tests assess the standalone performance of the device (Model 8006CA/8006PI) in conjunction with the Nonin Medical SenSmart Model X-100 Universal Oximetry System. The regional oximetry accuracy cited from the predicate device's clinical testing also represents standalone algorithm performance in measuring rSO2.

7. The Type of Ground Truth Used

For the regional oximetry accuracy (rSO2), the ground truth typically involves a reference method for measuring regional oxygen saturation, often arterial blood gas analysis or other established physiological measurements, in a controlled hypoxemic study. However, the specific type of ground truth used for the predicate device's clinical testing (K102715) is not explicitly stated in this document. Given the nature of oximetry, it would likely be a direct physiological measurement.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. Since the validation relies on the "critical sensor optics technology... remains unchanged" from predicate devices and the device is a measurement sensor rather than an AI/machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of machine learning is not directly applicable here.

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

As no training set is discussed or implied for an AI/ML model, this information is not applicable here. The device's performance is based on its physical and optical design, not on learned patterns from a dataset.

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