Search Results
Found 10 results
510(k) Data Aggregation
(294 days)
The Protektor32 channel system, composed of both hardware and software, is intended to be used for intracperative neurological monitoring. The instrument uses Electroencephalogical by (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery.
The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, lornrovin, or compression) or vascular insufficiency.
The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows:
- The EEG, EP, and EMG waveforms are intended to help the user assess a patient's . neurological status during surgery.
- Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier . transform (FFT) displays (compressed spectral array or CSA, density spectral array or DSA) are intended to help the user analyze the EEG and EP waveforms.
This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.
The Protektor32 channel system, composed of both hardware and software.
This document is a 510(k) clearance letter from the FDA for a medical device called "Protektor32." It describes the intended use and regulatory classification of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the given input. The letter focuses on regulatory approval and substantial equivalence to predicate devices, not on a detailed analysis of a clinical study or device performance metrics.
Ask a specific question about this device
(175 days)
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- . The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity . of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
This document, a 510(k) clearance letter for the Natus Medical Incorporated Olympic Brainz Monitor, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The letter is the FDA's clearance, indicating substantial equivalence to a predicate device. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number/qualifications of experts, or adjudication method for a test set.
- Information on MRMC comparative effectiveness studies or human reader improvement data.
- Results from standalone algorithm performance studies.
- The type of ground truth used in a study.
- Sample size or ground truth establishment methods for a training set.
The letter primarily confirms that the device, an electroencephalograph acquisition system, is substantially equivalent to existing devices for its stated indications for use, which include recording, displaying, and facilitating manual marking of aEEG recordings in neonatal patients, and assisting in the prediction of and severity of Hypoxic-Ischemic Encephalopathy in full-term neonates.
To obtain the information requested, one would typically need to review the actual 510(k) submission document (K093949) to the FDA, which would contain the performance summary and details of any studies conducted to support the substantial equivalence claim.
Ask a specific question about this device
(416 days)
The Neuroworks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
- The Neuroworks EEG software allows acquisition, display, archive, review and analysis . of physiological signals.
- The Seizure Detection component of Neuroworks is intended to mark previously . acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
- The Spike Detection component of Neuroworks is intended to mark previously acquired l sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp nontage according to the standard 10/20 system.
- The aEEG functionality included in Neuroworks is intended to monitor the state of the 포 brain. The automated event marking function of Neuroworks is not applicable to aFEG.
- Neuroworks also includes the display of a quantitative EEG plot, Compressed Spectrum 1 Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicalle to CSA.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
The Neuroworks is EEG software that displays physiological signals.
This document is a 510(k) premarket notification decision letter from the FDA for the Natus Neuroworks, Model 104196. It details the device's indications for use but does not contain information about the acceptance criteria, specific study details, or performance results that would typically be reported for an AI/ML medical device.
The device, Natus Neuroworks, is referred to as "EEG software" with components for "Seizure Detection" and "Spike Detection." However, the letter predates the widespread acceptance and specific regulatory pathways for AI/ML performance evaluation in medical devices. At the time of this letter (2010), the focus was primarily on substantial equivalence to predicate devices under the general controls provisions of the Act.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No Acceptance Criteria or Device Performance: The document does not list any quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) for the Seizure Detection or Spike Detection components.
- No Study Details: There is no description of a study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- No AI/ML Specific Evaluations: The document does not mention multi-reader multi-case (MRMC) studies, standalone algorithm performance, or training set details, which are standard for evaluating AI/ML models. While the device has "automated event marking functions," the regulatory review in 2010 did not necessitate the level of detail now expected for AI/ML performance studies.
In summary, the provided document confirms the substantial equivalence of the Natus Neuroworks device to a predicate device based on its indications for use, but it does not include the detailed performance study information required to answer your specific questions about acceptance criteria and how a study proved the device meets them.
Ask a specific question about this device
(389 days)
The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.
The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application for use with the Navigator Pro hardware platform for the recording of evoked responses (i.e., electrical potentials) upon the presentation of sensory stimuli.
The ENoG Protocol works on the basis of a repeating stimulus-response cycle. It is a convenience feature developed for the user to quickly set up testing for Electroneuronography evaluation of the facial nerves. The protocol utilizes the existing technology of the evoked response somatosensory function of the software. The evoked response from the patient is recorded through the use stimulus electrodes positioned near the mastoid, a cathode behind the earlobe, and an anode in front of the earlobe with the forehead as the ground.
The provided document describes a 510(k) summary for the Navigator Pro, AEP Software Modification - ENoG, which is an evoked response somatosensory stimulator. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance metrics like accuracy, sensitivity, or specificity.
Instead, the submission focuses on substantial equivalence to predicate devices by comparing technological characteristics and ensuring safety and effectiveness through adherence to design control specifications and risk analysis. The "study" mentioned below refers to the safety and effectiveness summary provided in the document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific acceptance criteria (e.g., minimum sensitivity, specificity, or quantifiable performance metrics) for the ENoG Protocol, nor does it report numerical device performance against such criteria. The "acceptance" discussed is primarily in the context of substantial equivalence to predicate devices and adherence to quality systems and risk management.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical performance study using a test set of patient data with a specified sample size.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There's no mention of a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no test set for which an adjudication method would be required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The device is not presented as an AI-assisted diagnostic tool in this context, but rather as a software modification to an existing evoked response system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The document explicitly states: "The ENoG protocol feature does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." This indicates that the device is intended for use with a human-in-the-loop, and no standalone performance study without human intervention is mentioned.
7. Type of Ground Truth Used
Not applicable. Since no performance study comparing device output to a known truth is described, there's no mention of the type of ground truth used.
8. Sample Size for the Training Set
No. The document does not describe a machine learning algorithm that requires a training set. The ENoG Protocol is described as a "convenience feature" and a "Windows® based software application" that utilizes "existing technology of the evoked response somatosensory function of the software."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm.
Summary of the "Study" (Safety and Effectiveness Summary):
The "study" or assessment demonstrating safety and effectiveness relied on:
- Internal Product Development Procedures: The device was developed in accordance with Bio-logic's internal product development procedures, which are stated to meet ISO-9001, ISO 13485:2003, and FDA QSR Design Control specifications.
- Hazard/Risk Analysis: A detailed Fault Tree Analysis (FTA) was performed for the Evoked Potential family of products.
- Risk Assessment: A detailed Risk Assessment for the AEP Software was written in accordance with ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices.
- Human-in-the-Loop: A key aspect of safety is that "All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." The program also allows users to review raw data and perform other analyses.
- Substantial Equivalence: The primary argument for market clearance is that the ENoG Protocol is substantially equivalent to legally marketed predicate devices, with differences in technological characteristics not raising new issues of safety or effectiveness.
In conclusion, the given document describes a regulatory submission centered on substantial equivalence and a risk management approach to safety, rather than a clinical performance study with specific quantitative acceptance criteria and reported device performance.
Ask a specific question about this device
(30 days)
The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestation age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
The ALGO 5 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 5 generates soft clicks at 35 dB nHL or at 40 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones).
Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity.
The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).
The provided text is a 510(k) summary for the Natus Medical ALGO 5 Newborn Hearing Screener, which is a modification of a predicate device (ALGO 3). The submission specifically states that no clinical performance data is included and that the substantial equivalence is based on non-clinical performance data (design verification and validation) showing the ALGO 5 performs equivalently to the ALGO 3.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance for a clinical study cannot be extracted from this document. The document explicitly states "No clinical performance data are included."
However, I can provide the limited information available regarding the comparison with the predicate device and the type of performance data used for substantial equivalence.
Here's what can be inferred from the provided text about the device's performance given the context of a 510(k) submission for a device modification:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical performance data is included, there's no specific table of clinical acceptance criteria or reported clinical device performance in this document. The equivalence is based on non-clinical data.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable, as no clinical test set data is provided.
- Data Provenance: Not applicable, as no clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set and thus no ground truth established by experts is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set is discussed.
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 document states "No clinical performance data are included." Also, this device is an automated hearing screener that does not involve human readers interpreting results in the way an MRMC study typically assesses. It uses an "automated auditory brainstem response technology (AABR)".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an automated screener, meaning its operation is essentially "standalone" in its assessment. However, the document doesn't present a standalone study as typically requested for AI/ML devices. Instead, it relies on demonstrating equivalence to the predicate device through non-clinical means. The "ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR)." This implies standalone algorithmic performance is inherent to its function, but a specific standalone performance study report is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance data or ground truth for a clinical study is discussed. The device's algorithm uses a "template of ABRs derived from normal hearing infants," which serves as an internal reference for its automated determination.
8. The sample size for the training set:
Not applicable. The document does not describe a new training set. The ALGO 5 is a modification of the ALGO 3 and relies on "advanced signal processing technology to separate the ABR from background noise and from other brain activity" and a "statistical algorithm." The "template of ABRs derived from normal hearing infants" likely refers to data used in the development of the original algorithm (ALGO 3) or the modification, but specific training set details are not provided in this 510(k) summary.
9. How the ground truth for the training set was established:
Not applicable. As no training set details are provided, the method for establishing its ground truth is also not mentioned. The document only references a "template of ABRs derived from normal hearing infants."
Ask a specific question about this device
(88 days)
The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to vrovide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming tat hlast or incubator.
Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant's eyes from excessive light exposure.
LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.
The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.
This is a 510(k) premarket notification for a medical device called the "neoBLUE cozy LED Phototherapy System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical efficacy studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the traditional sense of an AI/software efficacy study. Instead, it demonstrates that the new device is as safe and effective as already legally marketed predicate devices.
However, I can extract information related to the device's performance based on the comparison provided:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a 510(k) and not a clinical trial, "acceptance criteria" are not explicitly stated as performance metrics to be met by a study. Instead, the substantial equivalence is based on comparing the new device's features and specifications to those of predicate devices. The "reported device performance" are the specifications of the new device.
| Feature | Implied "Acceptance Criteria" (from Predicate) | Reported Device Performance (Natus neoBLUE cozy LED Phototherapy System) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | For the treatment of neonatal hyperbilirubinemia |
| Treatment Method | Underbaby phototherapy (Medela BiliBed) / Overhead phototherapy (Natus Blue Light) | Underbaby phototherapy |
| Targeted Population | Neonates | Neonates |
| Sites of Use | Clinical setting, home-use (Medela BiliBed) / Clinical setting (Natus Blue Light) | Clinical setting, home-use |
| Type of Light | Blue light fluorescent (Medela BiliBed) / Blue light (LED) (Natus Blue Light) | Blue light (LED) |
| Intensity | Approx. 40-60 µW/cm²/nm or more (Medela BiliBed) / 30-35 µW/cm²/nm (Natus Blue Light) | 30-35 µW/cm²/nm |
| Dimensions (Height) | 13.0 cm (5.1 in) (Medela BiliBed) | <6.4 cm (2.5 in) patient surface, ≤12.7 cm (5.0 in) rest of device |
| Dimensions (W x L) | 32.6 cm (12.8 in) width x 63 cm (24.8 in) length (Medela BiliBed) | 30.5 cm (12.0 in) width x 64.8 cm (25.5 in) length |
| Weight | 5 kg (11 lbs) (Medela BiliBed) | <4.3 kg (9.5 lbs) |
| Treatment Area | Not Published (Medela BiliBed) / 1250 cm² (200 in²) (Natus Blue Light) | Minimum 613 cm² (95 in²) |
| Electrical Safety | EN 60606-1, UL 2601-1, CSA C22.2 601.1, EN 60601-2-50 (Natus Blue Light) | EN 60606-1, UL 2601-1, CSA C22.2 601.1, EN 60601-2-50 |
| Thermal Safety | Fan to cool circuitry, minimize device heating (Natus Blue Light) | Fan to cool circuitry, minimize device heating. Thermal protection circuit - turns off LEDs if device gets too warm. |
| Radiation Safety | LED light source emits no significant ultraviolet light (Natus Blue Light) | LED light source emits no significant ultraviolet light |
| Ingress of Liquids | IPX1 (Medela BiliBed) | IPX4 |
Regarding "study that proves the device meets the acceptance criteria" and other related points:
The document explicitly states: "This submission includes the results of testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the nonclinical testing."
This indicates that a study was performed internally to verify the device's specifications (e.g., light intensity, safety features, dimensions, weight, electrical standards compliance) matched the design and were comparable to the predicate devices. However, the details for most of your specific questions are not provided in this 510(k) summary.
Here's a breakdown based on the provided text, and what is not mentioned:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The testing was on "prototype devices," suggesting a small number of devices rather than a large clinical "test set" of patients.
- Data Provenance: Not specified, but generally, testing for 510(k) submissions of this nature would be conducted in a laboratory or engineering setting by the manufacturer (Natus Medical, Inc., USA). This would be retrospective in the sense that the device was fully designed before testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a hardware phototherapy unit, not an AI/software device requiring expert interpretation of results to establish "ground truth." The ground truth for device performance is based on direct physical measurements and engineering standards (e.g., light intensity, temperature, electrical safety).
4. Adjudication method for the test set:
- Not Applicable. As above, no "test set" in the context of expert review or consensus is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a hardware medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used:
- For the physical and functional aspects of the device, the "ground truth" would be established through:
- Engineering specifications and measurements: E.g., light intensity measured by a radiometer, temperature measured by a thermometer, dimensions measured by calipers.
- Compliance with recognized standards: Electrical safety (EN 60606-1, UL 2601-1, etc.), ingress protection (IPX4).
- Biological/Physiological understanding: The efficacy relies on the known spectral absorption of light by bilirubin.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set as it's not an AI/ML device.
Ask a specific question about this device
(26 days)
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The ALGO 3i Newborn Hearing Screener is a modification of the ALGO 3 Newborn Hearing Screener. The ALGO 3i and the ALGO 3 Newborn Hearing Screeners have the same intended use and use the same operating principle. The new device performs and is specified within all performance parameters of the predicate device.
The provided 510(k) summary for the ALGO® 3i Newborn Hearing Screener (K030823) explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
Therefore, based on the provided document, the device did not undergo a study to demonstrate its performance against specific acceptance criteria. The submission indicates that the device is a modification of the ALGO 3 Newborn Hearing Screener (K013137) and that it "performs and is specified within all performance parameters of the predicate device." This implies that its acceptance was based on its substantial equivalence to the predicate, rather than new performance data.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Ask a specific question about this device
(76 days)
The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure. Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory. The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure. There are no single-use components or accessories for the Natus Blue Light Phototherapy device.
The Natus® Blue Light Phototherapy Unit is a medical device intended for the treatment of neonatal hyperbilirubinemia. The 510(k) summary provides details on the device's acceptance criteria and the non-clinical study conducted to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the device's performance specifications in comparison to a predicate device, the Olympic Bili-Lite™ Model 33. The acceptance criteria are implicitly derived from these performance specifications and safety standards.
| Feature | Acceptance Criteria (Natus Blue Light Phototherapy Unit) | Reported Device Performance (Natus Blue Light Phototherapy Unit) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | Meets intended use |
| Target Population | Neonates | Neonates |
| Sites of Use | Nursery, doctor's office, anywhere phototherapy is delivered | Nursery, doctor's office, anywhere phototherapy is delivered |
| Light Source Type | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Light Source Number | Approx. 750 LEDs | Approx. 750 LEDs |
| Light Source Life | 10,000 hr (low setting); 3,000 hr (high setting) | Meets specification |
| Light Source Color | Blue | Blue |
| Wavelength | 400-550 nm, Peak @ 450-475 nm | Meets specification |
| Intensity (at 30 cm distance) | Low: 15 ± 2 μW/cm²/nm; High: 35 ± 3.5 μW/cm²/nm | Low: 15 μW/cm²/nm; High: 35 μW/cm²/nm (within tolerance) |
| Light Intensity Adjustment | High/Low switch adjusts between two levels of intensity | High/Low switch present |
| Operating Voltage | 85-264VAC | 85-264VAC |
| Overload Protection (fuses) | 2A @ 120V | 2A @ 120V |
| Current Leakage | < 100 uA | < 100 uA |
| Fan | 24 VDC Fan | 24 VDC Fan |
| Acoustic Noise | < 35 dB | < 35 dB |
| Operating Temperature | 50 - 86° F (10 - 30° C) | Meets specification |
| Storage Temperature | 23 - 122° F (-5 to +50° C) | Meets specification |
| Operating Humidity | 10 to 90% non-condensing | Meets specification |
| Storage Humidity | 0 to 90% non-condensing | Meets specification |
| Electrical Safety | EN 60601-1 and 1-1-2, UL 2601-1, CSA/CAN C22.2 601.1, EN 60601-2-50 | Complies with specified standards |
| Mechanical Safety | Plastic diffuser minimizes accidental viewing, protects baby and lights from incidental debris | Plastic diffuser present and functions as described |
| Thermal Safety | Fan to cool circuitry, minimize device heating; LEDs give off little heat by design | Fan present, LEDs confirmed to give off little heat |
| Radiation Safety | LED light source produces minimal ultraviolet light | Confirmed minimal UV light production |
| Controls and Indicators | On/Off power switch, High/low intensity switch, Positioning light | Controls and indicators present as described |
| Compatibility | Can be used outside a bassinet or incubator, under a radiant warmer; Tilt adjustments standard | Meets compatibility requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the submission includes "the results of testing prototype devices to specifications." However, it does not specify the exact sample size (i.e., how many prototype devices were tested) or the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). This information is not detailed in the provided text.
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 testing described is non-clinical and focuses on device specifications and safety standards, rather than clinical efficacy studies involving expert evaluation of patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. The testing described is non-clinical and focuses on device specifications and compliance with standards. There is no mention of a human-based adjudication process for a test set in the context of clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states that it includes "the results of testing prototype devices to specifications, spectral characterization of the blue LED light source, and an analysis of the potential optical radiation hazard." This is a non-clinical evaluation focused on substantial equivalence to a predicate device, not a comparative clinical effectiveness study involving human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device described is a phototherapy unit, a physical medical device, not an AI-powered algorithm. The testing described is purely engineering and performance-based to ensure the device meets its specifications and safety standards.
7. The Type of Ground Truth Used:
The "ground truth" used for this device's evaluation is primarily based on engineering specifications, physical measurements, and compliance with established safety and performance standards. This includes:
- Spectral characterization of the blue LED light source.
- Measurements of light intensity, wavelength, operating voltage, current leakage, acoustic noise, temperature, and humidity.
- Verification of compliance with electrical, mechanical, thermal, and radiation safety standards (e.g., EN 60601-1, UL 2601-1).
- Assessment of physical design features and controls against the described specifications.
There is no mention of a clinical "ground truth" such as pathology, expert consensus on patient outcomes, or other clinical efficacy data because this was a non-clinical submission.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The Natus Blue Light Phototherapy Unit is a hardware device, not an algorithm that requires a training set. The "prototype devices" mentioned in the non-clinical testing are the subject of evaluation, not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, this device is not an AI/algorithm that requires a training set. The "ground truth" for the device's performance relies on engineering principles, recognized standards, and direct physical measurements.
Ask a specific question about this device
(27 days)
The ALGO® 3 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
Like the predicate device, the ALGO 3 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 3 generates soft clicks at 35 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones); a 35 dB nHL stimulus will detect a 30 dB nHL hearing loss. Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The screener uses advanced signal processing technology to separate the ABR from background noise and from other brain activity. The ALGO 3 automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology), and prints a "PASS" or "REFER" result. A "PASS" result is printed if the ALGO 3 can detect, with sufficient statistical confidence, that an ABR is present and consistent with its template. A "REFER" result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template. A built-in printer prints the result on a self-adhesive label, which can be affixed directly to the infant's medical chart.
The ALGO 3 is also capable of screening using clicks at 40 dB nHL. Some newborn hearing programs (international programs, for example), and some programs prefer to set the screening threshold at 40 dB nHL rather than at 35. The incorporation of a 40 dB screening application in the ALGO 3 device makes the device more useful to more users.
The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required, as the screener automatically determines if the response is consistent with a template and automatically generates a "PASS" or "REFER" result, as previously discussed. In addition, training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software.
Screening results can be tracked using the integrated ALGO DataBook® NHS Data Tracking System software. The DataBook utility retrieves and displays patient and screening data stored in ALGO 3 software. Data can be viewed on the ALGO 3's display; can be saved as an ASCII file on diskette for data management and reporting purposes; and can be exported to other databases for data management and reporting purposes.
There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters.
The ALGO 3 is composed of the following components, as is the Predicate Device:
- Screening module, with laptop computer
- Printer module, with label printer
- Cable assemblies (ATA, PCA, Preamp)
- Cart for transport and component storage
- Screening and accessory supplies
Accessories available for use with the ALGO 3 include single-use, disposable FlexiCouplers Disposable Earphones, and single-use, disposable Jelly Tab Sensors.
The provided text does not contain detailed information regarding specific acceptance criteria or a dedicated study proving the device meets said criteria with quantitative performance metrics. This document primarily focuses on the device's description, intended use, and substantial equivalence to a predicate device for 510(k) clearance.
However, based on the information provided, we can infer some aspects and highlight what is missing.
Here's an attempt to structure the answer based on your request, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from functionality) | Reported Device Performance (Implied) |
|---|---|
| Accuracy: Ability to correctly identify "PASS" (hearing present) or "REFER" (hearing loss suspected) based on ABR response. | The ALGO 3 "automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants... and prints a 'PASS' or 'REFER' result." "A 'PASS' result is printed if the ALGO 3 determines, with sufficient statistical confidence, that an ABR is present and consistent with its template. A 'REFER' result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template." |
| Sensitivity for 30 dB nHL hearing loss: Detects hearing loss at this threshold. | "A 35 dB nHL stimulus will detect a 30 dB nHL hearing loss." |
| User proficiency: Ease of use by trained non-medical personnel. | "The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required... training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software." |
| Screening time: Efficiency of the screening process. | "A typical screening process can be completed in 15 minutes or less." |
| Reproducibility/Consistency: Consistent results under the same conditions. | "There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters." |
The document does not provide quantitative performance metrics such as sensitivity, specificity, positive predictive value, or negative predictive value from a specific study to directly validate these criteria. The emphasis is on similarity to the predicate device, the ALGO-2 Newborn Hearing Screener, which likely had its own performance data for establishing substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided text. The document describes the device's functionality and comparison to a predicate but does not detail a specific clinical trial or study undertaken for the ALGO 3's 510(k) submission that would involve a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not explicitly stated in the provided text. The device uses an "automated auditory brainstem response technology" and "compares the baby's ABR to a template of ABRs derived from normal hearing infants." It does not mention human experts establishing ground truth for individual test cases in the context of a validation study for the ALGO 3's performance itself. The "template of ABRs" would have been established previously, potentially using expert interpretation from a historical dataset.
4. Adjudication Method for the Test Set
This information is not explicitly stated in the provided text, as there is no described specific test set or clinical study for the ALGO 3 featuring human adjudication. The device itself performs an automated "PASS" or "REFER" determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not described or indicated in the provided text. The ALGO 3 is designed to be automated, used by "trained volunteers and other trained non-medical personnel," with "interpretation of screening results is not required." Therefore, a study comparing human readers with and without AI assistance is not relevant to the described operational model of the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone algorithm in its core function. It "automatically determines if the response is consistent with a template and automatically generates a 'PASS' or 'REFER' result." The document implies that the device's performance, given its automation, is its standalone performance. However, no specific study detailing this standalone performance (e.g., sensitivity, specificity vs. a gold standard clinical diagnosis) is provided in this summary. The 510(k) submission relies on substantial equivalence to a predicate device, not necessarily a new standalone clinical trial for the ALGO 3 itself.
7. Type of Ground Truth Used
The ground truth for the device's operation is implicitly "ABRs derived from normal hearing infants." The device's algorithm compares the captured ABR to this established template. The ultimate ground truth relevant to "hearing loss" would be a clinical diagnosis of hearing loss, but the document describes the device comparing to a "template" of normal ABRs, which acts as the reference for its automated decision-making.
8. Sample Size for the Training Set
This information is not explicitly stated in the provided text. The "template of ABRs derived from normal hearing infants" would have been the equivalent of a training or reference set, but its size is not mentioned.
9. How the Ground Truth for the Training Set Was Established
The text states the ALGO 3 "compares the baby's ABR to a template of ABRs derived from normal hearing infants." This implies that the template was established by taking ABR readings from a cohort of infants confirmed to have normal hearing. How this "normal hearing" was confirmed (e.g., through follow-up audiological assessments, other screening methods, or clinical consensus) and the methodology for creating the "template" (e.g., statistical averaging, machine learning model) is not detailed in this document.
Ask a specific question about this device
(78 days)
The Natus Breath Analyzer is intended for non-invasive, quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously.
The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affected by the rate of hemolyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired.
The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.
The Natus Breath Analyzer system is a point-of-care test that consists of the instrument and a single-use patient sampler. The patient sampler incorporates a flexible nasal catheter with a filter cartridge that attaches to the device. An integral adhesive strip on the catheter aids in proper placement in the nostril.
The computer-controlled instrument contains two gas analysis sensors: an infra-red carbon dioxide sensor and an electrochemical carbon monoxide sensor. The signal produced by the carbon dioxide sensor is analyzed to determine the end tidal carbon dioxide concentration and the respiratory rate. The signal produced by the carbon monoxide sensor is analyzed to determine the average carbon monoxide concentration. The end tidal carbon monoxide concentration is calculated by an algorithm using carbon monoxide and carbon dioxide concentrations.
During the automated test procedure the device displays appropriate prompts. The user operates the instrument by selecting menu options from the display screen. During sampling, a small volume of the patient's breath is continuously drawn into the instrument for a short time. Results are displayed and printed at the end of the test.
The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement technology as the predicate devices.
Here's an analysis of the provided text regarding the Natus Breath Analyzer's acceptance criteria and study, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Natus Breath Analyzer. Instead, the primary acceptance criterion appears to be substantial equivalence to predicate devices. The performance is reported in terms of this equivalence across various patient populations and measured parameters.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for: - End tidal carbon monoxide measurement - End tidal carbon dioxide measurement - Respiratory rate measurement | Demonstrated substantial equivalence in adult and pediatric populations for all three measurements. |
| Demonstrated substantial equivalence in neonatal population for carbon dioxide and respiratory rate measurements. | |
| Accurate measurement for a wide range of breath parameters (simulated) | Device accurately measured end tidal CO, end tidal CO2, and respiratory rate for various simulated breath parameters (rate, tidal volume, gas concentrations, I:E ratio), including neonatal values. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated. The document mentions "adult, pediatric, and neonatal subjects" and "three clinical sites" but does not provide specific numbers for the total subjects or per population.
- Data Provenance: The data is prospective, generated from a "clinical study" performed on actual patients. The country of origin is not explicitly stated, but given the 510(k) application to the FDA, it is highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the establishment of a "ground truth" by experts in the traditional sense (e.g., expert consensus on images). Instead, the clinical study compared the Natus Breath Analyzer's measurements to those of predicate devices (Vitalograph and Pryon). Therefore, the "ground truth" for the clinical study was derived from the measurements provided by these already-marketed, presumably validated, devices.
4. Adjudication Method for the Test Set
Not applicable. The study design described is a comparative one against predicate devices, not one involving independent expert adjudication to establish a "ground truth" separate from the comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where multiple human readers interpret cases with and without AI assistance. The Natus Breath Analyzer is a measurement device for respiratory gases, and the study focused on device-to-device comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was effectively done. The clinical study directly compared the Natus Breath Analyzer's measurements (algorithm output) to those of predicate devices. The non-clinical tests also assessed the device's accuracy in a standalone capacity using a breathing simulator.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on measurements from predicate devices (Vitalograph and Pryon). For the non-clinical tests, the ground truth was derived from known, controlled parameters set on a breathing simulator.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device, not a machine learning algorithm that undergoes a training phase with a dedicated dataset. The device's algorithms for calculating end-tidal CO, CO2, and respiratory rate are based on established scientific principles and sensor data, not a "training set" in the context of recent AI/ML development.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of this device. The underlying physics and chemical principles of the sensors and calculations form the basis of the device's operation.
Ask a specific question about this device
Page 1 of 1