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The Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

The Appraise-Cardio Sample Collection Kit is a Sample Collection Kit which is sent to the patient's home after the kit has been ordered by the patient's physician. The kit consists of the following:

• A Sample Collection Tube. -
• A Sample Collection Capillary Tube. -
• -A Sample Tube Holder Box.
• A Patient Identification Card which contains the patient's name, address, Social Security Number, t information, the physician's name and phone number and a bar code number that is peeled off and affixed to the Sample Collection Tube after the sample has been taken.
• A pamphlet containing detailed information about the lipid program and instructions on how to obtain a blood sample and mail it to a laboratory.
• A plastic zip lock bag marked "Specimen Collection Envelope" into which the Sample Collection Tube is placed.
• An absorbent pad that is contained in the Specimen Collection Envelope. -
• A plastic zip lock bag marked "Waste". -
• A self-adhesive envelope in which the specimen envelope is inserted and then mailed to the preprinted address on the envelope.
• -A sterile lancet
• -An alcohol swab
• A sterile gauze pad -
• -A sterile adhesive bandage
• The mailing envelope which is used to mail the above items to the patient. .
  The Sample Collection Tube, Sample Collection Capillary Tube, lancet, alcohol swab, gauze pad and adhesive bandage are all legally marketed, commercially available items.
  After receiving the Appraise-Cardio Sample Collection Kit in the mail, the patient then collects a blood sample, using a lancet supplied in the kit or purchased separately by the patient. The blood sample is placed in the Sample Collection Tube as described in the instructions. The bar code sticker from the Patient Identification Card is then affixed to the Sample Collection Tube which is then placed in the Specimen Collection Envelope. The Patient Information Card and Specimen Collection Envelope are then placed in the mailing envelope. The mailing envelope is then sealed and sent to a laboratory for processing. When the blood sample is received by the laboratory the patient's total cholesterol, triglycerides and HDL values are measured using existing reagent kits.

The Osborn Group Appraise-Cardio Sample Collection Kit is a device intended for collecting blood samples at home or a physician's office, which are then mailed to a laboratory for analysis of total cholesterol, triglycerides, HDL, and LDL. The primary concern addressed by the testing was to ensure that the blood samples remain accurate even after being subjected to the extreme temperatures and humidity conditions that can occur during mail delivery.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or stability).
The reported device performance is: "The results were within acceptable limits." This qualitative statement indicates that the environmental testing confirmed the samples' accuracy was maintained.

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

The document does not specify the sample size used for the environmental testing.
The data provenance is not explicitly stated, but the study appears to be prospective as it involved subjecting the Appraise-Cardio Sample Collection Kit to simulated environmental conditions. It is implied the samples were collected and then intentionally exposed to these conditions for testing purposes. No information is provided regarding the country of origin of the data.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. It implies that standard laboratory analytical procedures and existing reagent kits were used to measure the lipid values, but does not detail the process of defining "acceptable limits" or who verified the ground truth before and after environmental exposure.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It states that the "results were within acceptable limits," suggesting a comparison against predetermined standards or baseline measurements, but the process for making this determination is not described (e.g., whether multiple experts reviewed the results and reached a consensus).

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. This type of study is typically associated with image-based diagnostic devices where human readers interpret results, sometimes with AI assistance. The Appraise-Cardio Sample Collection Kit is a blood sample collection and transport system, and the testing focused on sample stability rather than interpretive performance by human readers or AI.

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

No, a standalone (algorithm only) performance study was not done. The device itself is a collection kit; the analysis of the blood sample is performed by "existing reagent kits" in a laboratory. The testing focused on the integrity of the collected sample after transport, not on an algorithm's performance.

7. The Type of Ground Truth Used

The type of ground truth used is implicitly laboratory measurement data from existing reagent kits for total cholesterol, triglycerides, HDL, and LDL. The "acceptable limits" for these measurements post-environmental exposure likely referred to established clinical ranges or stability criteria for these analytes, comparing them to initial measurements of the same samples or control samples.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning components. Therefore, the concept of a training set sample size is not applicable to this device or its reported testing.

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

As there is no mention of a training set or machine learning components, this question is not applicable.

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The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following:

• A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected
• A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc.
• A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it
• A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. -
• A sterile lancet -
• An alcohol swab -
• A gauze pad -
• An adhesive bandage -
• -An outer package containing all of the items listed above
  After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.

The provided text is a 510(k) summary for the HemoChek-A1c Sample Collection Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a detailed study.

Therefore, many of the requested information points (1-9) about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in this type of regulatory submission.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it asserts "substantial equivalence" to predicate devices. The core "acceptance criteria" in this regulatory context is the demonstration that the new device is as safe and effective as a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated. The summary mentions "Information contained in this submission demonstrates..." but does not detail the size of any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). Regulatory submissions for substantial equivalence often rely on various types of data, but the specifics are not in this summary.

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

• Not applicable/Not stated. Ground truth establishment by experts in the context of diagnostic accuracy is not discussed here, as the focus is on substantial equivalence of a sample collection kit. The "ground truth" would likely relate to the accuracy of the HbA1c assay itself, which is a separate established methodology.

4. Adjudication Method for the Test Set:

• Not applicable/Not stated. Since a specific "test set" and a diagnostic accuracy study with multiple readers are not described, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned as the device is a sample collection kit, not an AI or imaging diagnostic device where MRMC studies are common.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. The HemoChek-A1c is a physical sample collection kit, not an algorithm, so a "standalone" performance study in the context of AI is not relevant. The performance evaluation would focus on its ability to collect and preserve samples for subsequent laboratory analysis.

7. The Type of Ground Truth Used:

• Not explicitly stated in relation to device performance. For a sample collection kit, "ground truth" would likely involve the accurate measurement of HbA1c in the lab using established, validated assay methods on samples collected with the kit compared to other methods (e.g., venous blood draw). The summary only states that "the patient's HbA1c level is measured using existing assay methods."

8. The Sample Size for the Training Set:

• Not applicable/Not stated. This refers to machine learning models, which is not the nature of this device.

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

• Not applicable/Not stated. As above, this pertains to machine learning and not a physical sample collection kit.

Summary of available information:

The document is a 510(k) summary demonstrating substantial equivalence for a medical device (HemoChek-A1c Sample Collection Kit) to existing predicate devices (EZCHEK™/HbA1c Sample Collection Kit and HemoChek Sample Collection Kit). The primary "study" referred to is the submission of information that "demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device." No specific detailed study, sample sizes, or performance metrics within that study are provided in this summary, as the regulatory path relies on demonstrating similarity to already cleared devices.

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The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.

The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following:

• A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
• A Specimen Tube with a screw-on lid, containing preservative fluid.
• A clear plastic sealed envelope that contains both of the above items.
• A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
• A set of instructions.
• A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
• A mailer into which the zip lock bag is placed.
• A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.

The provided text describes a 510(k) summary for the HemoChek Urine Collection Kit, a device intended for collecting and preserving urine specimens for laboratory testing of creatinine and microalbumin concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed table of exact performance metrics. Instead, the "Summary of Device Testing" section provides a qualitative statement about the device's performance relative to preserved urine.

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

• Sample Size: The document does not specify the exact sample size ("number of urine pools" or "number of specimens") used for the testing. It vaguely states: "several tests were conducted from the same urine pool".
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

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

The document does not mention the involvement of experts to establish a "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" in this study refers to the chemical concentrations of creatinine and microalbumin in urine specimens. This "ground truth" would be established by laboratory analysis using validated assays on both HemoChek collected samples and comparator (preserved and unpreserved) urine samples. It is implied that standard laboratory practices and accredited testing methods were used to determine these concentrations, but details about the specific laboratory or personnel qualifications are not provided.

4. Adjudication Method for the Test Set

Not applicable. This study focuses on the analytical performance of the collection and preservation method for specific biochemical markers, not on the interpretation of medical images or diagnostic decisions that would typically require an adjudication method among experts.

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

No. An MRMC study is typically used to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. This document describes the evaluation of a physical urine collection and preservation device, not an AI algorithm, and therefore an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical urine collection kit, not an algorithm. The "standalone performance" in this context refers to the device's ability to collect and preserve urine specimens such that the analytes within remain stable for subsequent laboratory testing, which is implicitly what the "Summary of Device Testing" addresses.

7. Type of Ground Truth Used

The ground truth used was laboratory analytical results for creatinine and microalbumin concentrations. The comparison was made between:

• Specimens collected with the HemoChek device
• Preserved urine specimens (presumably collected using a standard, established preservation method)
• Unpreserved urine specimens (presumably tested immediately or under controlled conditions)

The "ground truth" for the HemoChek device's performance was its ability to yield "substantially the same results" as these comparator samples.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device (urine collection kit), not a machine learning model or algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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