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The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.

The provided text describes different aspects of the HCG Home Use Pregnancy Test devices, including acceptance criteria and study results. However, it does not explicitly state acceptance criteria in a dedicated section with pass/fail metrics. Instead, the performance characteristics implicitly define the acceptance criteria by demonstrating performance comparable to the predicate device and meeting expected analytical standards for a qualitative pregnancy test. I will synthesize the information to best answer your request.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria are not stated, I will infer them from the reported analytical performance deemed acceptable for demonstrating substantial equivalence. The predicate device's characteristics also serve as an implicit benchmark.

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

• Analytical Performance Studies (Precision, Specificity, Interference, etc.):

  • Precision/Reproducibility (Intra-batch, Inter-batch): For each of the three device formats (Strip, Cassette, Midstream), 3 lots were tested. For each lot and each of the 6 HCG concentration levels (0, 12.5, 18.75, 25, 50, 100 mIU/mL), 20 samples were tested. Total samples: 3 formats * 3 lots * 6 concentrations * 20 samples = 1080 samples.
  • Precision/Reproducibility (Inter-day, Inter-round): For each of the three device formats, 3 lots were tested. Over 5 days, with 2 runs per day, three operators tested blinded and randomized samples. For each lot and each of the 6 HCG concentration levels, the number of tests was (5 days * 2 runs per day * 20 samples) = 200 samples. Total samples: 3 formats * 3 lots * 6 concentrations * 200 samples = 10,800 samples.
  • Inter-laboratory Precision: For each of the three device formats, tests were performed at 3 sites using 3 lots. For each site, lot, and each of the 6 HCG concentration levels, the number of tests was (3 sites * 3 lots * 20 samples (implied from the table similar to batch precision)). Total samples: 3 formats * 3 sites * 3 lots * 6 concentrations * 20 samples = 3240 samples.
  • Cross-reactivity: Tested with specific concentrations of hLH, hFSH, hTSH using 3 lots of the test kits. The exact number of individual samples tested for each reactant is not specified, but it's stated "no cross reactivity was observed."
  • Interference: Tested with various common substances at specific concentrations for urine samples containing 0, 10, and 25 mIU/mL hCG. Three batches of each format were tested. The exact number of individual samples tested for each substance is not specified.
  • High Dose Hook Effect: 10 hCG-free specimens spiked at various high concentrations (5,000 to 1,000,000 mIU/mL) were tested on three lots of devices for each format. Total samples: 10 specimens * 8 concentrations * 3 lots * 3 formats = 720 samples.
  • HCG β-core fragment: Normal non-pregnant women urine specimens (0, 10, 25 mIU/mL hCG) spiked with varying concentrations of β-core fragment. Three lots of each format were tested. The exact number of individual samples tested is not specified.

• Clinical Studies (Method Comparison and Lay User Study):

  • Method Comparison with Predicate Device: A total of 300 urine samples from females of childbearing age (18 to 48 years) were collected. These were split for the 3 device formats: 100 for Strip, 100 for Cassette, 100 for Midstream. Within each device format, 50 positive and 50 negative samples were used.
  • Lay User Study: 300 women participated (100 for each device format: Strip, Cassette, Midstream). Each woman tested her own urine sample. Within each device format, 50 positive and 50 negative samples were used.

• Data Provenance:

  • Origin: The submitter is Anhui DEEPBLUE Medical Technology Co. LTD., located in Hefei, Anhui, People's Republic of China, and the designated correspondent is in Shanghai, China. The document does not explicitly state the country of origin for the samples, but given the company's location, it is highly likely the studies were conducted in China.
  • Retrospective or Prospective: The studies (both analytical and clinical) appear to be prospective as samples were collected and tested as part of the study design ("samples were collected at various time throughout the day and were randomized prior to testing," "A total of 300 urine samples from females of childbearing age were collected in this clinical trial").

3. Number of Experts and Qualifications

• Analytical Studies: "different operator" and "three operators" are mentioned for precision studies. No specific expert qualifications (e.g., radiologist) are provided, but these would typically be laboratory technicians or trained personnel.
• Clinical Studies (Method Comparison): "laboratory professionals at 3 clinical study unit" performed testing with the candidate device. "Results reported by a laboratory professional using the predicate device" were used for comparison in the lay user study. No specific qualifications beyond "laboratory professionals" are given.
• Ground Truth Establishment: The ground truth for HCG concentrations in analytical studies was established by spiking pooled negative female urine with HCG traceable to WHO 5th International Standards. For clinical studies, the predicate device results, as interpreted by laboratory professionals, served as the comparative ground truth.

4. Adjudication Method

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the test results. For the precision studies, multiple operators and lots were used to demonstrate consistency, but no specific adjudication process for conflicting results is mentioned. For the method comparison and lay user studies, results were compared directly, and 100% agreement was reported, implying no need for adjudication for those specific metrics.

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

• No MRMC comparative effectiveness study was done. The studies compared the device's performance to established HCG concentrations (analytical) or to a predicate device (clinical), and also assessed lay user performance against professional predicate results. There is no mention of comparing human readers' performance with and without AI assistance, as these are qualitative, visually-read home-use pregnancy tests, not AI-assisted imaging devices.

6. Standalone (Algorithm Only) Performance

• Yes, the device's analytical performance (sensitivity, specificity, interference, hook effect) can be considered its "standalone" performance, as it quantifies the ability of the test strip/cassette/midstream itself to detect/react to HCG in urine according to its chemical and biological design. The "method comparison" and "lay user study" sections further demonstrate the device's performance when interpreted by either professionals or lay users. Since this is a qualitative immunoassay, the "algorithm" is the biochemical reaction itself and the visual interpretation of colored lines.

7. Type of Ground Truth Used

• Analytical Studies:
  • For sensitivity and precision, the ground truth was known HCG concentrations in urine achieved by spiking pooled negative female urine with HCG (traceable to WHO 5th International Standard).
  • For specificity and interference, the ground truth involved known concentrations of potential interfering substances or cross-reactants.
• Clinical Studies (Method Comparison and Lay User Study):
  • The ground truth was established by the results of the predicate device as interpreted by laboratory professionals. This implies that the predicate device is considered the gold standard for comparison in these studies.

8. Sample Size for the Training Set

• This document describes performance studies for a medical device (HCG Home Use Pregnancy Test Strip, Cassette, Midstream). These devices are rapid chromatographic immunoassays and do not involve machine learning or AI models, therefore, there is no concept of a "training set" in the context of the provided information. The studies described are for validation of the device's analytical and clinical performance.

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

• As stated above, this device does not utilize a training set in the machine learning sense.

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Sterile and Non-Sterile Ultrasonic Coupling Agent are ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to cound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The subject device, Sterile and Non-Sterile Ultrasonic Coupling Agent, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the Ultrasonic Coupling Agent is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.

The document describes the premarket notification (510(k)) for a medical device called "Sterile and Non-Sterile Ultrasonic Coupling Agent." It provides information about its intended use, technical characteristics, and performance testing to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, formatted to answer your questions:

Acceptance Criteria and Study Proving Device Meets Criteria

The device under review is an "Ultrasonic Coupling Agent," which is a gel used to facilitate ultrasound imaging. The acceptance criteria for this type of device are primarily based on its physical and chemical properties, biocompatibility, and sterilization effectiveness (for sterile versions). The study proving the device meets these criteria is a series of non-clinical bench tests and compliance with recognized consensus standards, demonstrating substantial equivalence to a legally marketed predicate device. No clinical study was performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table summarizing performance testing (bench tests) for the subject device against specified acceptance criteria.

2. Free from stratification, mildew, and odor under normal storage conditions. | Pass | Pass |

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

The document does not specify the exact sample sizes (e.g., number of batches, number of samples per batch) used for each bench test. These are typically detailed in the full test reports, which are summarized here.

The data provenance is from non-clinical bench testing performed by the manufacturer, Anhui Deepblue Medical Technology Co., Ltd., located in Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA. The testing is retrospective in the sense that it was conducted as part of the product development and regulatory submission process.

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

This document describes a premarket notification for an ultrasonic coupling agent, which is a physical material, not an AI/software device that generates diagnostic outputs requiring expert interpretation. Therefore, the concept of "ground truth established by experts" in the context of image interpretation (e.g., radiologists) does not apply to this submission. The "ground truth" for the performance tests (e.g., sound velocity, pH) is established by the validated measurement methods and equipment used in the laboratory.

4. Adjudication Method for the Test Set

As this is a submission for a physical medical product based on laboratory bench testing and not an AI or diagnostic imaging device requiring human expert consensus for "ground truth," an "adjudication method" involving multiple experts is not applicable. The results are determined by instrumental measurements and standardized material testing procedures.

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 relevant for diagnostic devices (especially AI-powered ones) where human readers interpret cases, and the AI's impact on their performance is evaluated. For an ultrasonic coupling gel, this type of study is not relevant or required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the sense of an algorithm's performance without human interaction was not done. This device is a passive material, not an algorithm. Its "performance" is its physical and chemical properties and ability to conduct ultrasound waves.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective physical and chemical measurements obtained through validated laboratory testing methods (bench tests) and compliance with recognized standards. This includes:

• Physical properties (Sound Velocity, Acoustic Impedance, Sound Attenuation, Viscosity, Density, pH) measured by instruments.
• Microbial limits and sterility confirmed by microbiological testing.
• Biocompatibility assessed against ISO 10993 standards.
• Packaging and shelf-life validated per ISO 11607-1, ASTM F88/F88M-15, ASTM D3078.

There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for a coupling agent's performance in the same way it would be for a diagnostic tool or treatment.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. This device is a physical product (ultrasound gel), not an AI algorithm that undergoes training on a dataset. The formulation and manufacturing processes are developed and validated, but there isn't a "training set" in the machine learning sense.

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

As there is no "training set" for this physical device, this question is not applicable.

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