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510(k) Data Aggregation
(180 days)
The WELLlife COVID-19 Antigen Test Rx is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the WELLlife COVID-19 Antigen Test Rx and followed with a molecular test.
A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.
Positive results do not rule out co-infection with other respiratory pathogens and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Performance characteristics for SARS-CoV-2 were established from April 2023 to February 2024 when SARS-CoV-2 Omicron was dominant. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.
The WELLlife COVID-19 Antigen Test Rx is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for prescription use only.
The WELLlife COVID-19 Antigen Test Rx consists of the following components:
- Test Cassette
- Tube (pre-filled extraction buffer)
- Swab
- Tube Holder
- Quick Reference Instructions (QRI)
- Instructions for Use (IFU)
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(119 days)
The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).
The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the sensor to determine systolic pressure and diastolic pressure.
The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.
This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.
This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).
The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Measuring Accuracy (Static Pressure): $\pm$3mmHg (based on predicate device spec) | $\pm$3mmHg for static pressure (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Measuring Accuracy (Pulse Rate): $\pm$5% of the reading (based on predicate device spec) | $\pm$5% of the reading for the pulse rate (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Biocompatibility: Compliance with ISO 10993-5 and ISO 10993-10 | All user-directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements (claimed to be same materials as predicate) |
| Electrical Safety: Compliance with ANSI AAMI ES 60601-1 | Complies with ANSI AAMI ES 60601-1 |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Home Healthcare Environment: Compliance with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| Automated Non-Invasive Sphygmomanometers: Compliance with ISO 80601-2-30 | Implied compliance through similar specifications and general statement of performance. The standard itself outlines the performance requirements for such devices. |
| Software Verification & Validation: Compliance with FDA guidance | Performed in accordance with "Guidance for the Content of Premarket Submissions for Software Contained In Medical Devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.
4. Adjudication Method for the Test Set
Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method 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 MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).
8. The Sample Size for the Training Set
Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.
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(137 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm. The electric wheelchair is classified as class A and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator light, ON/OFF button, horn button, speed indicator, speed increase button, speed decrease button, joystick, battery charger socket), arm supports, push handle, two rear wheels, two casters(front wheels), foot supports, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.
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(58 days)
- Pulp Capping
- Repair of Root Perforation
- Repair of Root Resorption
- Root-end Filling
- Apexification
Well-Root PT is ready-to use, premixed, bioceramic paste developed for pulp capping, permanent root canal repair and filling. Well-Root PT is delivered by the capsule containing the mixture of calcium silicate cement, liquid and several compound particles. It sets in the root without the mixing process with additional water.
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(30 days)
Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Wisdiag Multi-Drug Urine Home Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for over-the-counter use.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The device is in a ready-to-use format and no longer requires assembly before use.
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(91 days)
Water-soluble Personal Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of pure water, glycerin, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, sodium lactate, flavors, ethylenediaminetetraacetic acid, etc. The subject device includes four different flavors of water-soluble personal lubricants: Vitamin E flavor, Caramel flavor, Peach flavor, and Strawberry flavor. This device is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
The lubricant is packaged in PE bottles of 100gm.
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(91 days)
The Wearable Breast Pump (Model S33) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model S33) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.
It is an electrically powered, software-controlled, digital pump. It is powered by a rechargeable lithium ion battery (3.7 V, 1000mAh) that can be charged using the USB cable provided with the device. The device is designed not to be used during charging. The device utilizes an embedded control program to manage all product functions and does not incorporate any off-the-shelf (OTS) software. The main components of this pump include pump motor, valve, flange, silicone diaphragm, USB charging cable, bra extension strap and milk collector. The pump is provided non-sterile and reusable by a single user in home environment.
There are four (4) operating modes available for the device – Stimulation mode, Expression mode, Massage mode, and Auto mode. The device includes nine (9) suction levels within each mode. Wearable Breast Pump (Model S33) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 91 -121 cycles per minute in Stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 27-88 cycles per minute in Expression mode, vacuum levels from 40-120 mmHg with cycling rates from 92-130 cycles per minute in Massage mode and vacuum levels from 40-245 mmHg with cycling rates from 27-121 cycles per minute in auto mode. The device is equipped with an LED status display that displays information regarding working mode, operating time, and battery status. The user interface includes on/off switch that also acts as mode selection switch (through long press), pause button and vacuum level adjustment buttons.
Wearable breast pump (Model S33) is designed to be used as a single pumping system that can be converted to double pumping by using two devices, one on each breast. To prevent milk from flowing into the vacuum system, the device uses a silicone diaphragm that physically separates the milk contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.
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(199 days)
The WatchPAT400 (WP400) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The device is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP400 generates a peripheral arterial tonometry ("PAT"), Respiratory Disturbance Index ("pRDI"), Apnea-Hypopnea index ("pAHI"), Central Apnea-Hypopnea index ("pAHIc"), sleep staging identification (pSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The device's pSTAGES and snoring level and body position provide supplemental information to its pRDI/pAHI/pAHIc. The device's pSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
pAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
The WP400 is a ventilatory effort recorder that utilizes PAT technology. The controller part of the device is worn on the wrist and records the PAT signal and arterial blood oxygen saturation levels by a finger-mounted probe based on an optical plethysmographic method. An actigraph, embedded in the wrist worn controller unit, records wrist motion that is used to determine periods of sleep vs wake. A chest sensor is attached to the patient's chest right under the sternal notch for measuring snoring level, body position states and chest movements. The device is battery powered and connects via Bluetooth to a mobile application.
The WP400 is a re-usable device, with sensors common with the WP300 and wireless connectivity identical to the WP1. With the same core technology, signal acquisition, and signal processing identical across all three WatchPAT devices, the WP400 is a combination of its predecessors: device housing leveraged from the WP300 for its re-usable nature, combined with the ability for wireless communication leveraged from the WP1. Signals recording, processing, and analysis has not changed from the predicate devices.
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(190 days)
The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model W6) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Wearable Breast Pump (Model W6) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump includes: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and hot compress modes and control the vacuum levels within those modes.
The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level <= 42 degrees Celsius. The Wearable Breast Pump (Model W6) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.
The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
This FDA 510(k) clearance letter pertains to a Wearable Breast Pump (Model W6), not an AI/software device that requires acceptance criteria for algorithm performance. The acceptance criteria and study detailed in the provided text are focused on the hardware performance, safety, and functionality of a physical medical device (a breast pump), not the diagnostic or analytical performance of an AI model.
Therefore, many of the requested items related to AI model evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and the studies performed to prove the device meets these criteria as described in the 510(k) summary, reframing them to fit the provided sections where possible.
Acceptance Criteria and Device Performance for Wearable Breast Pump (Model W6)
Given that this document describes a physical medical device (a breast pump) and not an AI/software for diagnosis or analysis, the acceptance criteria and performance studies are focused on the device's functional safety and efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated) | Reported Device Performance (from "Summary of Non-Clinical Performance Testing") |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for patient contact materials. | Leveraged from predicate device; in accordance with 2023 FDA guidance. Implies successful demonstration of biocompatibility. |
| Electrical Safety | Compliance with IEC 60601-1 Ed 3.2, IEC 62133-2:2017, and IEC 60601-1-11 Ed 3.1. | Testing conducted successfully. Implies successful demonstration of electrical safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014+A1:2020. | Testing conducted successfully. Implies successful demonstration of electromagnetic compatibility. |
| Software Functionality | Software functions as intended and meets "Basic Documentation level" requirements per FDA guidance. | Evaluated at the Basic Documentation level successfully. Implies successful verification of software functionality. |
| Vacuum Level Verification | Devices meet specified vacuum ranges (±5 mmHg) for each mode. - Stimulation: 40-120 mmHg - Expression: 105-245 mmHg - Massage: 40-150 mmHg - Auto: 40-245 mmHg | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual vacuum levels fall within the stated ranges. |
| Cycle Speed Verification | Devices meet specified cycling rates (±2 cycles/minute) for each mode. - Stimulation: 90-143 cycles/min - Expression: 30-105 cycles/min - Massage: 87-128 cycles/min - Auto: 30-143 cycles/min | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual cycle speeds fall within the stated ranges. |
| Backflow Protection | Liquid does not backflow into the tubing. | Testing verified liquid does not backflow into the tubing. Implies successful backflow protection. |
| Use Life Consistency | Devices maintain specifications throughout their proposed use life. | Testing conducted to demonstrate devices maintain specifications. Implies successful use life performance. |
| Battery Performance | Battery remains functional during its stated battery use-life. | Testing conducted to demonstrate battery remains functional. Implies successful battery performance. |
| Battery Status Indicator Functionality | Battery status indicator remains functional during its stated battery life. | Testing conducted to demonstrate indicator remains functional. Implies successful battery status indicator performance. |
| Hot Compress Temperature | Hot compress function remains functional during stated use-life and provides a heating level ≤ 42 ºC. | Testing conducted to demonstrate hot compress function remains functional. Implies successful temperature control (≤ 42 ºC) and functionality throughout use-life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each performance test (e.g., number of units tested for vacuum, cycle speed, use-life, etc.). It only states that "testing was conducted."
- Data Provenance: Not specified in terms of country of origin or whether the underlying studies were retrospective or prospective. These are typically laboratory performance tests, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This relates to evaluation of AI/diagnostic algorithms. For a physical device like a breast pump, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human graders of images or clinical data.
4. Adjudication Method for the Test Set
- Not applicable. This relates to resolving discrepancies in expert labeling for AI/diagnostic algorithms. For device performance testing, adjudication is generally a process of reviewing test results against predefined engineering limits and specifications, not expert consensus on qualitative data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, not specified and not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes the performance of a physical breast pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable for the overall device performance in the context of typical AI review. While the breast pump does have "embedded software," the performance described (vacuum, cycle speed, battery, etc.) is the device's standalone performance, not an algorithm's diagnostic or analytical performance. The document states "Software was evaluated at the Basic Documentation level," which refers to standard software validation processes for medical devices, not an "algorithm-only" performance study in the AI sense.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is derived from established international standards (IEC 60601 series, ISO 10993-1) and the device's own design specifications (e.g., specific vacuum ranges, cycle speeds, temperature limits). These are objective, measurable criteria. For example, a vacuum gauge provides the "ground truth" for vacuum level, and a timer/counter for cycle speed.
8. The Sample Size for the Training Set
- Not applicable. This device does not use a "training set" in the context of machine learning. Its internal software is "embedded" and controls device functions based on pre-programmed logic, not learned from data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8).
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(90 days)
WELLlife Flu A&B Home Test:
The WELLlife Flu A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
WELLlife Influenza A&B Test:
The WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare providers.
Positive results do not rule out co-infection with other respiratory pathogens.
Test results should not be used as the sole basis for treatment or other patient management decisions.
The WELLlife Flu A&B Home Test and WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use (WELLlife Flu A&B Home Test) and one for professional use (WELLlife Influenza A&B Test). Both versions of the WELLlife Influenza A&B Test that have an identical general design and are intended for the qualitative detection of protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms. Results are for the identification and differentiation of nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with three lines: two test lines (Flu A line, Flu B line) and a control line (C line). The device is for in vitro diagnostic use only.
The provided FDA Clearance Letter for the WELLlife Flu A&B Home Test includes details on the device's performance based on non-clinical and clinical studies. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for performance are generally implicit in these types of submissions, aiming for high agreement with a comparative method. The reported performance is presented through Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
Table 1: Acceptance Criteria and Reported Device Performance (Implicit Criteria)
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Influenza A) | Reported Device Performance (Influenza B) |
|---|---|---|---|
| Clinical Performance (Agreement): | |||
| Positive Percent Agreement (PPA) | High agreement, typically >90% for acute infections [Implied] | 92.4% (95% CI: 87.2%-95.6%) | 91.4% (95% CI: 77.6%-97.0%) |
| Negative Percent Agreement (NPA) | Very high agreement, typically >98% [Implied] | 100% (95% CI: 99.3%-100%) | 100.0% (95% CI: 99.4%-100%) |
| Non-clinical Performance (Precision): | |||
| Lot-to-Lot Repeatability (1x LoD, positive) | 100% agreement over multiple lots, operators, and days [Implied] | 100% (180/180) | 100% (180/180) |
| Lot-to-Lot Repeatability (Negative) | 0% false positives [Implied] | 0% (0/180) | 0% (0/180) |
| Site-to-Site Reproducibility (1x LoD, positive) | Near 100% agreement across sites and operators [Implied] | 97.0% (131/135) | 99.3% (134/135) |
| Site-to-Site Reproducibility (Negative) | 0% false positives [Implied] | 0% (0/135) for Negative Sample | 0.7% (1/135) for Flu B High Negative (0.1x LoD) |
| Non-clinical Performance (Analytical Sensitivity): | |||
| Limit of Detection (LoD) | Specific concentrations where ≥95% detection is achieved | Ranges from $3.89 \times 10^0$ to $4.17 \times 10^2$ TCID50/mL for A strains | Ranges from $1.17 \times 10^1$ to $1.05 \times 10^3$ TCID50/mL for B strains |
| Non-clinical Performance (Analytical Specificity): | |||
| Cross-reactivity / Microbial Interference | No cross-reactivity or interference with listed organisms/viruses | 0/3 for all microorganisms/viruses tested | 0/3 for all microorganisms/viruses tested |
| Endogenous Interfering Substances | No interference with listed substances at specific concentrations | No interference with most substances, except FluMist Quadrivalent Live Intranasal Influenza Virus Vaccine (false positive at high concentrations) | No interference with most substances, except FluMist Quadrivalent Live Intranasal Influenza Virus Vaccine (false positive at high concentrations) |
| High Dose Hook Effect | No hook effect observed at high viral concentrations | 9/9 positive for Flu A strains | 9/9 positive for Flu B strains |
| Competitive Interference | Detection of low levels of one analyte in presence of high levels of another | 100% detection for all tested combinations | 100% detection for all tested combinations |
Study Details
1. A table of acceptance criteria and the reported device performance
- See Table 1 above. The acceptance criteria are inferred from what is typically expected for a diagnostic device of this type seeking FDA clearance (e.g., high sensitivity and specificity, consistent performance).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Clinical Study: 680 evaluable subjects (from 766 enrolled) were used for clinical performance evaluation.
- Non-clinical Studies: Sample sizes vary by study:
- Lot-to-Lot Precision: 180 results per sample type (3 lots x 3 operators x 2 replicates x 2 runs per day x 5 days).
- Site-to-Site Reproducibility: 135 replicates per sample type (3 sites x 3 operators x 5 days).
- LoD: 20 replicates for confirmatory testing.
- Analytical Reactivity: Triplicates for initial range finding, then triplicates for two-fold dilutions.
- Cross-Reactivity/Microbial Interference: 3 replicates per organism/virus.
- Endogenous Interfering Substances: 3 replicates per substance.
- High Dose Hook Effect: 9 replicates (across 3 lots).
- Competitive Interference: 9 replicates for each combination.
- Data Provenance:
- Clinical Study: "A prospective study was performed... between January 2025 and March 2025... at six (6) clinical sites." The country of origin is not explicitly stated, but the FDA clearance implies US-based or FDA-accepted international clinical trials. It's a prospective study.
- Non-clinical Studies: Performed internally at one site (Lot-to-Lot Precision) or at three external sites (Site-to-Site Reproducibility). These are also prospective experimental studies.
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)
- The ground truth for the clinical test set was established using an "FDA-cleared molecular comparator method." This is a laboratory-based, highly sensitive, and specific molecular test, which serves as the gold standard for detecting influenza RNA/DNA.
- There is no mention of human experts (e.g., radiologists, pathologists) being used to establish the ground truth for this in vitro diagnostic device. The comparator method itself is the "expert" ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe an adjudication method for conflicting results between the investigational device and the comparator method. Results from the WELLlife Flu A&B Home Test were compared directly to the FDA-cleared molecular comparator method. For an in-vitro diagnostic, typically the molecular comparator is considered the definitive truth.
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 MRMC study was performed. This device is a lateral flow immunochromatographic assay, a rapid antigen test that produces visible lines interpreted directly by the user (either a lay user at home or a professional user). It does not involve "human readers" interpreting complex images or AI assistance in the interpretation of results in the way an imaging AI device would. Therefore, this question is not applicable to the WELLlife Flu A&B Home Test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is primarily relevant for AI/ML-driven software as a medical device (SaMD) where an algorithm provides an output. The WELLlife Flu A&B Home Test is a rapid diagnostic test interpreted visually. Its performance is inherent to the chemical reactions on the test strip, and it's designed for human interpretation (either self-testing or professional use). Therefore, a "standalone algorithm-only" performance study is not applicable in the context of this device's technology. The "device performance" metrics (PPA, NPA) are effectively its standalone performance as interpreted by a human user following instructions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the clinical study was an FDA-cleared molecular comparator method (e.g., PCR or equivalent), considered the gold standard for influenza detection.
8. The sample size for the training set
- The provided document describes clinical and non-clinical performance evaluation studies. For IVD devices like this one, it's common that the "training set" is not a distinct, formally defined dataset as it would be for a machine learning model. Instead, the device's design, reagent formulation, and manufacturing processes are optimized and validated through iterative development and verification testing (analogue to "training" and "internal validation"). The studies described in this summary are primarily validation studies demonstrating the final product's performance. Therefore, a specific "training set sample size" as one might see for an AI model is not applicable/not explicitly defined in this context.
9. How the ground truth for the training set was established
- As mentioned above, for a rapid diagnostic test, there isn't a "training set" in the sense of a machine learning model. Instead, the development process involves:
- Analytical Validation: Establishing LoD, reactivity, specificity (cross-reactivity, interference) using reference strains, cultured microorganisms, and purified substances with known concentrations and characteristics. This essentially acts as the "ground truth" during the development phase.
- Design Iteration: The test components (antibodies, membrane, buffer) are optimized to achieve desired sensitivity and specificity against known influenza strains and potential interferents. This iterative process, using well-characterized samples, ensures the device learns (is developed) to correctly identify targets.
- The FDA-cleared molecular comparator assays serve as the ultimate "ground truth" against which the device's overall clinical performance is measured.
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