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The Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin A1c using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access AIC Test is for measurement of HbA1c on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes.

This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

The Home Access® A1C Test includes a micro-blood specimen collection kit. The collection kit is intended to facilitate in vitro laboratory testing of finger stick blood samples for a variety of clinical chemistry assays.

This collection kit includes components needed to self-collect, package and mail a dried micro-blood sample to the certified clinical laboratory for testing. The collection kit is comprised of:

• Blood Sample Collection Cassette
• Sample Pouch
• Sterile Safety Lancets (2)
• Gauze Pad
• Bandage (2)
• Instructions for use
• Prepaid Return Mailer
• Patient Info Card
• Outer Packaging

Here's an analysis of the acceptance criteria and the studies performed for the Home Access® A1C Test, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a pass/fail format with numerical targets. Instead, it describes various performance studies and their findings, which implicitly establish that the device meets certain performance expectations. The closest representation of acceptance criteria for linearity and bias are inferred from the study findings and standard guidelines.

Inferred Acceptance Criteria and Reported Device Performance:

• Abnormal High (12.52%): SD 0.18, CV% 1.40%
• High (8.92%): SD 0.16, CV% 1.81%
• Diabetic in control (6.83%): SD 0.11, CV% 1.64%
• Normal (5.85%): SD 0.06, CV% 1.09%
  Total Imprecision:
• Abnormal High: SD 0.19, CV% 1.50%
• High: SD 0.27, CV% 3.00%
• Diabetic in control: SD 0.27, CV% 3.93%
• Normal: SD 0.16, CV% 2.69% |
  | Linearity | Linear over the claimed assay range. | Linear over the assay range of 4.5% - 14.5% A1c. Linear fit: y = -0.0553x + 1.02, r=0.995. |
  | Interference | Bias from tested interfering substances 97.1%). |

Study Details:

2. Sample sizes used for the test set and the data provenance:

• Precision Study: N=80 per HbA1c level (total N not explicitly stated but based on 2 replicates/level, 2 runs/day for 20+ days per level).
• Linearity Study: 76 individually prepared dry blood samples (19 levels of HbA1c x 4 samples per level). 52 of these were capillary specimens collected from 13 volunteers. The remaining were six commercially available venous whole blood specimens, each spotted onto four Cassettes.
• Interference Study: The number of samples for each interferent is not specified, only the concentration levels tested.
• Product Stability (Cassette/Pouch): 53 levels of HbA1c.
• Product Stability (Mailed Sample): 128 self-collected capillary blood samples.
• Flex Studies:
  • Blood Volume: 420 cassettes (3 HbA1c levels x 14 blood volumes/level x 10 cassettes/volume).
  • Interruption: 90 cassettes (3 HbA1c levels across control and two time interval groups).
  • Hematocrit: Not explicitly stated but 39 HbA1c levels with six specimens per level (2 control, 2 high Hct, 2 low Hct).
  • Coating Solution: 53 levels of HbA1c.
• Method Comparison: 256 patient samples (128 self-collected, 128 professionally-collected).
• Data Provenance: The document does not explicitly state the country of origin for the patient data. It refers to "volunteers" and "patient samples" but no geographic location or demographic details. The studies are clinical laboratory performance studies, thus are likely for a U.S. regulatory submission. It is retrospective for the clinically collected samples (venous blood) used for comparison, and prospective for the collection of capillary blood (self-collected and professionally-collected) as part of the study design.

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 concept of "experts" for establishing ground truth in this context is primarily related to the analytical measurement from established, FDA-cleared laboratory systems, rather than human interpretation.

• The ground truth for HbA1c values was established using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter AU640e (K961274) and Beckman Coulter A1c reagents (K031380), which served as the reference method. These systems are inherently considered "expert" in their field for HBA1c measurement due to their regulatory clearance and established accuracy.
• For the Human Factors Studies, the "experts" were the lay-users themselves, as the study assessed their ability to understand and use the product. The number and qualifications of these lay-users are not specified beyond being "lay-users."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No adjudication method is described. The ground truth is based on objective laboratory measurements from a reference system.

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:

This is not applicable to this device. The Home Access® A1C Test is an in vitro diagnostic device for quantitative measurement of HbA1c, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers in that sense. There is no "AI" component, nor "human readers" interpreting images/data in a similar fashion to an MRMC study setup.

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

The system is a standalone algorithm/device in terms of its analytical performance. The "algorithm" here is the chemical assay and instrument processing. The testing described (precision, linearity, interference, stability, flex studies) directly assesses the performance of the device itself (collection cassette and subsequent lab analysis), which functions without human intervention during the measurement phase within the lab. However, the overall "test" involves a human (patient) for sample collection, and a laboratory for processing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the analytical performance studies (precision, linearity, interference, method comparison) was established by measurements obtained from an FDA-cleared predicate laboratory system (Beckman Coulter AU640e and A1c reagents) on venous blood samples. This is a reference standard measurement from a legally marketed device.

8. The sample size for the training set:

There is no explicit "training set" or "validation set" described in the context of an algorithm or AI. This is a medical device for chemical analysis. The studies described are performance verification studies for the device.

9. How the ground truth for the training set was established:

As there is no distinct "training set" in the AI/machine learning sense, this question is not applicable. The ground truth for the performance evaluations was established by the reference laboratory method as explained in point 7.

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The accessa Cholesterol Panel is intended for in vitro, quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol in dried micro-serum samples ("Cholesterol Panel"). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. The Cholesterol Panel is not intended for use on neonates. LDL-Cholesterol cannot be determined where the triglycerides value is greater than 400 mg/dL.

The accessa Cholesterol Panel incorporates the use of two separately regulated products.

• The Home Access Micro Serum Specimen (MSS) Collection Kit (a Class I Medical Device listed with the FDA effective February 19, 2003, and manufactured under the Quality System Regulations) and
• The Home Access Health Corporation (HAHC) Clinical Chemistry . Laboratory Lipid Profile Test Methods (Regulated under CLIA number 14D0981820).

The Home Access Micro Serum Specimen Collection Kit ("MSS collection kit"), (Class I Medical Device CFR 21 Part 864.3250, registered February 19, 2003) is intended to facilitate in vitro diagnostic laboratory testing of fingerstick blood samples for a variety of clinical chemistry assays. This MSS collection kit includes a collection cassette, storage pouch and prepaid mailer along with all the materials necessary to self-collect a capillary blood sample into the blood collection/transportation cassette. The cassette is packaged along with patient/customer information and transported to the certified clinical laboratory for lipid profile testing. In its final configuration, the accessa Cholesterol Panel kit is comprised of:

• . Blood collection/transportation cassette
• Sample Return Pouch with Desiccant .
• 2 Safety lancets ●
• Gauze pad .
• Adhesive bandage .
• . Instructions for use
• Brochure: "What you need to know to keep your heart healthy" .
• Prepaid US Mail return mailer .
• Informed Consent Form .
• Outer Box .

The patient/customer follows the directions to self-collect a capillary blood sample (approximately 100 micro liters), package and mail the sample to a certified clinical laboratory for analysis using FDA-cleared reagent and analysis systems. Once the dried sample is received in the laboratory, it is accessioned, labeled and eluted into a usable serum sample. Once eluted, the sample can be assaved as a diluted serum sample using US FDA-cleared reagents. All testing is done via the Roche Cobas Mira Plus chemical analyzer and utilizes the software approved for use in the testing instrument (K920402). The clinical laboratory is located at Home Access Health Corporation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the accessa Cholesterol Panel, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K063852) does not explicitly state specific numeric acceptance criteria for the accessa Cholesterol Panel. Instead, it makes a general claim of "substantial equivalence" to predicate devices and venous (serum) results.

However, the key performance claim is related to comparability with venous samples. Therefore, the reported performance is the qualitative statement of "substantial equivalence."

• Total Cholesterol
• HDL-Cholesterol
• Triglycerides
• Calculated LDL-Cholesterol | Not explicitly stated (implied clinical equivalence to predicate and venous results) | "Results of clinical trials show that self-collected capillary samples onto the accessa Blood Collection Cassette provide results that are substantially equivalent to venous (serum) results for Total Cholesterol, HDL-Cholesterol and Triglycerides when analyzed using Home Access Health Laboratories modified analytical methods."

"The results of clinical trials demonstrated that self-collected capillary samples, tested using the HAHC proprietary testing algorithm, are substantially equivalent to venous (serum) results for Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol." |

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

• Sample Size: The document does not specify a precise sample size for the clinical study. It mentions subjects, but not the number of them.
• Data Provenance: The formal clinical study was conducted independently by the LMARC Research Center in Louisville, KY, USA. The data is prospective, as samples were collected specifically for the study ("between March 2006 and May 2006").

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

There is no mention of experts being used to establish ground truth in the traditional sense of a consensus or adjudication panel. The "ground truth" for the performance comparison was established by comparing the results from the self-collected capillary samples against venipuncture samples (serum) from the same subjects. These venipuncture samples were then analyzed using FDA-cleared reagent and analysis systems at the certified clinical laboratory.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication method described for establishing ground truth, as ground truth was based on venipuncture serum samples analyzed by established laboratory methods.

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

No, this was not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a sample collection and transport system intended for laboratory analysis, not an interpretative diagnostic tool requiring human reader comparison.

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

Yes, in a sense. The core of the performance evaluation is the performance of the "accessa Cholesterol Panel" which includes the collection kit and the HAHC Clinical Chemistry Laboratory Lipid Profile Test Methods. The comparison is between the results obtained from the collected capillary samples (processed by the HAHC lab) and the venipuncture serum samples (also processed by standard lab methods). While humans are involved in laboratory analysis, the "device" itself (collection and transport) is evaluated based on the analytical results produced by the laboratory method, not on human interpretation of an image or data. The "proprietary algorithm" mentioned in the summary refers to the laboratory's internal processing and analytical methods for the eluted sample, not an AI algorithm for diagnosis.

7. The Type of Ground Truth Used

The ground truth used was venipuncture serum sample results obtained from "FDA-cleared reagent and analysis systems" using standard laboratory test methods (Total Cholesterol: Amresco Cholesterol Reagent Assay K891922, HDL Cholesterol: Wako L-Type HDL-C Reagent Assay K801834, Triglycerides: Roche Triglycerides K801298). This can be classified as a form of reference standard laboratory testing.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description focuses on the "clinical study" which served as the validation for the device performance. The "proprietary algorithm" mentioned is likely the standard laboratory's analytical method, which would have been established and validated through internal lab procedures, not a distinct "training set" in the machine learning sense.

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

As no specific "training set" for a machine learning algorithm is described, this question is not directly applicable. The "proprietary algorithm" refers to the HAHC Clinical Chemistry Laboratory Lipid Profile Test Methods. The ground truth for validating these laboratory methods would have been established through standard laboratory quality control, calibration, and validation procedures, typically against certified reference materials or established gold-standard methods.

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