(85 days)
The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of The recor crimites I visual in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva. The ACCU-CHEK Performa system is comprised of: The ACCU-CHEK Performa blood glucose monitor, The ACCU-CHEK Performa blood glucose test strip, The ACCU-CHEK Performa Control Solutions. The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electric current in the test strip. The meter reads the current and gives a blood glucose result.
This 510(k) summary for the ACCU-CHEK Performa System is very brief and primarily focuses on establishing substantial equivalence to the predicate device, the ACCU-CHEK Aviva System. It explicitly states that "All predetermined acceptance criteria were satisfied" and that the data "demonstrates that the ACCU-CHEK Performa is substantially equivalent to the predicate device." However, it does not provide detailed performance metrics, acceptance criteria values, or specific study designs beyond general statements.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment cannot be found in the provided text. The document relies on the assertion that performance characteristics are maintained and acceptance criteria were met, without disclosing the specifics.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| The document states "All predetermined acceptance criteria were satisfied" but does not define these criteria or provide specific performance metrics. | The document states the device "maintains performance characteristics with ACCU-CHEK Aviva" but does not quantify these characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned in the provided text.
- Data Provenance (Country of Origin): Not mentioned in the provided text.
- Retrospective or Prospective: Not mentioned in the provided text.
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)
- This type of information is not relevant for a blood glucose monitoring system, which typically uses laboratory reference methods for ground truth, not expert consensus on images. The document does not mention experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Ground truth for blood glucose meters is established by comparison to a laboratory reference method, not by expert adjudication of interpretations.
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
- Not applicable. This is a blood glucose monitoring device, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Blood glucose meters operate in a standalone manner, providing a quantitative result directly. The performance studies would have evaluated the accuracy of the device itself against a reference method. The phrase "Performance testing on the ACCU-CHEK Performa System demonstrated that the device meets the performance requirements for its intended use" indicates this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established using a laboratory reference method (e.g., a YSI glucose analyzer) to determine the true glucose concentration in blood samples.
8. The sample size for the training set
- Not mentioned. The document describes performance testing, which implies a test set, but does not detail any "training set" for an algorithm. While the device is "based on the ACCU-CHEK Aviva System," there's no mention of specific algorithm training data in this summary.
9. How the ground truth for the training set was established
- Not mentioned, as no training set details are provided.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.