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510(k) Data Aggregation
(36 days)
The BiliChek Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.
The Bilichek consists of the BiliChek hand-held unit, the BiliCal Individual calibration tips, a charger base, and rechargeable battery packs. The BiliChek hand-held unit contains a light source, a fiberoptic probe, a microspectrometer, and a microprocessor control circuit within an 8.5 x 2x 4 inch assembly. The hand-held unit is battery powered and is controlled by an internal microprocessor. Operator interface with the microprocessor is achieved through three buttons and a liquid crystal display (LCD). The buttons are used to select different set-up options. The measurement is initiated when the operator presses the Trigger button on the bottom of the unit. The LCD window on the device displays the calculated bilirubin value, date and time, battery status, and permits the unit set-up parameters to be programmed. The BiliCal disposable tips protect the fiber-optic probe, ensure a hygienic contact with the patient, provide a means for calibration of the BiliChek, and serve as a positioning aid. The disposable tip includes a removable target with calibration material which is used in the initial calibration of the device prior to use on each patient. Before a measurement is taken, the BiliChek runs a baseline reference calibration scan which measures the removable target on the tip. After calibration, the target is removed from the tip to expose an optically clear window through which measurements are made. Sensors in the BiliChek detect when the tip is correctly installed and the depression of the tip under pressure when it is applied to the patient. Two rechargeable nickel-cadmium battery packs are supplied with the system. The battery pack is inserted in the bottom of the BiliChek Hand-held Unit. The BiliChek Hand-Held Unit includes status indicators which indicate if the battery is low or dead. When fully charged, each battery pack provides sufficient power to conduct 100 measurements. The Bilichek battery charger includes two charging wells, one for the Bilichek and the other for the spare battery pack. The charger is provided power from a 110 volt power supply.
The SpectRx BiliChek Non-Invasive Bilirubin Analyzer underwent clinical testing to demonstrate its ability to non-invasively measure bilirubin levels in neonates.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BiliChek device are not explicitly quantified with specific thresholds (e.g., a certain correlation coefficient or error margin) in the provided text. However, the reported performance states that the clinical testing demonstrated a "statistically and clinically significant correlation" between the BiliChek's measurements and serum bilirubin levels as indicated by HPLC.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to non-invasively measure bilirubin levels | Demonstrated in clinical testing. |
| Correlation with serum bilirubin levels (HPLC) | "Statistically and clinically significant correlation" between BiliChek and serum bilirubin levels measured by HPLC. |
| Performance across various demographic factors | "No significant differences in the performance of the BiliChek attributed to race, sex, gestational age at delivery, bodyweight, or presence in the NICU." |
| Safety (absence of adverse events) | "No injuries or deaths that occurred while the device was being used or any adverse effects reported from use of the device." |
| Intended Use Fulfillment (predict serum bilirubin, aid monitoring) | The device "is intended as an index to predict serum bilirubin levels" and "provides a numerical measurement of predicted bilirubin count... that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC)." It is used "to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the total number of neonates included in the clinical test set.
- Data Provenance: The country of origin of the data is not specified. The study was prospective in nature, as it involved "clinical testing... conducted to demonstrate the ability of the BiliChek device to non-invasively measure the bilirubin levels of infants... prior to the use of phototherapy or any related therapeutic intervention." This suggests real-time measurement on actual patients before interventions.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth in the traditional sense of consensus reading. The ground truth was established by laboratory measurement using HPLC.
4. Adjudication Method for the Test Set
No adjudication method involving experts is mentioned, as the ground truth was derived from laboratory measurements (HPLC).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the performance of the device against a gold standard (HPLC), not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was performed. The clinical testing described measures the performance of the BiliChek device directly against serum bilirubin levels obtained through HPLC, without the intervention of a human interpreter or decision-maker in the measurement process itself. The BiliChek "provides a numerical measurement of predicted bilirubin count in mg/dL."
7. Type of Ground Truth Used
The ground truth used was High Performance Liquid Chromatography (HPLC) measurements of total serum bilirubin concentration. This is a laboratory-based, objective measurement.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The description of the performance testing focuses on clinical validation of the device, which typically implies a test set rather than a training set for model development (though the device itself likely underwent internal development and calibration).
9. How the Ground Truth for the Training Set was Established
Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not described. If an internal training set was used during device development, it is highly probable that ground truth would have been established through a reference method like HPLC, similar to the clinical test set.
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(183 days)
The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek™ provides a numerical measurement of predicted bilirubin count in mo/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromotography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek™ test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.
The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer.
The provided document is limited to a 510(k) clearance letter for the Bilichek™ Non-Invasive Bilirubin Analyzer, and an "Indications for Use" statement. It does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them from the given text.
The document only states:
- Trade Name: Bilichek™, Non-Invasive Bilirubin Analyzer
- Regulatory Class: II
- Intended Use: "as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight."
- Performance Claim: "The Bilichek™ provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromatography (HPLC)."
To provide the requested information, a more comprehensive submission, such as the full 510(k) submission or a detailed clinical study report, would be necessary.
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