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The intended use of the SimpleChoice reservoir Pro is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

The SimpleChoice reservoir Pro (3.0mL), Reference Number RP-30, is a single use reservoir system used to deliver medications subcutaneously. The user fills the reservoir via a standard hypodernic needle provided with the device. The 3.0 ml reservoir Pro then attaches to an SimpleChoice infusion set having a female luer lock with a retainer feature, and is placed in an external infusion pump. If the reservoir will be used with a Paradigm pump the plunger rod is detached and the reservoir is secured with the retainer feature.

This 510(k) summary describes a device modification rather than a new device, and as such, the study conducted focused on demonstrating equivalence to the predicate device. Therefore, the information provided within the document does not contain all the details typically found in studies for novel devices, especially concerning detailed acceptance criteria and standalone performance metrics.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The new device is as safe, as effective, and performs the same as the original device, the SimpleChoice reservoir." and "The tests performed show such equivalence."

Study Details:

The provided document is a 510(k) summary for a device modification (SimpleChoice reservoir Pro) to an already legally marketed device (SimpleChoice reservoir). The entire premise of this submission is to demonstrate substantial equivalence to the predicate device, not to establish novel performance against specific quantitative criteria.

The summary states: "The modifications which are the subjects of this premarket notification have no untoward effect on the safety and effectiveness of the device." and "The tests performed show such equivalence." However, it does not detail the specific tests conducted, their methodologies, or the raw results (e.g., specific leakage rates, flow accuracy, material strength tests) that led to this conclusion. The focus is on the administrative aspects of obtaining 510(k) clearance based on equivalence.

Therefore, many of the requested details about the study cannot be extracted from this summary.

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

• Sample Size: Not specified in the provided document. The summary only mentions "tests performed."
• Data Provenance: Not specified. Given it's a device modification and likely bench testing, it would generally be considered prospective testing conducted by the manufacturer, but country of origin or specific lab is not mentioned.

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

• This is not applicable to this type of 510(k) submission. For a device modification seeking substantial equivalence, the "ground truth" is typically established by comparing the modified device's performance against the known and acceptable performance of the predicate device through engineering tests, rather than expert interpretation of medical data.
• No experts (e.g., radiologists) would be used in this context to establish a "ground truth" in the way one might for diagnostic AI.

4. Adjudication Method for the Test Set:

• Not applicable. This type of submission relies on objective engineering and performance testing, not subjective adjudication of cases.

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

• No. This is explicitly not an MRMC study. MRMC studies are typically for diagnostic imaging devices or algorithms where human readers' performance is being evaluated or compared, often with and without AI assistance. This device is an infusion reservoir.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• Not applicable in the typical sense. A standalone study, as usually understood in the context of AI, refers to the algorithm's performance independent of human input. This device is a mechanical component of an infusion system.
• However, if interpreted as "bench testing of the device itself without human intervention affecting its inherent function," then the undisclosed "tests performed" would likely fall into this category (e.g., pressure tests, flow rate consistency, material compatibility). The document does not provide details of these tests.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is the established safety and performance of the predicate device. The tests (though not detailed) would have aimed to demonstrate that the modified device's performance metrics are equivalent to or better than those of the predicate. This is based on engineering specifications and established performance characteristics of the original SimpleChoice reservoir, rather than pathology, expert consensus, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. As above, this is not an AI/machine learning device.

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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.

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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