(266 days)
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, and GH83 BT Blood Glucose Monitoring System quantitatively measures the glucose in the whole blood sample by using a harmless electrical current produced by a chemical reaction between the glucose in the blood and Flavin adenine dinucleotide-Glucose dehydrogenase (FAD-GDH) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements from this system are reported as plasma equivalents.
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring Systems are for over-the-counter use and systems' kit basically consist of a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, a carrying case, however some kits may not have test strips or a lancing device or sterile lancets. The Medisign GH81. GH82. GH83 Blood Glucose Monitoring System allows to transmit blood glucose test results to a PC via an external USB cable and Medisign GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring System can transmit blood glucose test results to a PC via an external USB cable or a Bluetooth Low Energy transmitter in meter.
The Medisign GH81 Blood Glucose Test Strip is for the Medisign GH81 and GH81 BT Blood Glucose Meter. The Medisign GH82 Blood Glucose Test Strip is for the Medisign GH82 and GH82 BT Blood Glucose Meter. The Medisign GH83 Blood Glucose Test Strip is for the Medisign GH83 and GH83 BT Blood Glucose Meter.
Each of test strip box may contain 10 test strips or 25 test strips or 50 test strips with one vial or 50 test strips split into two vials. Also, test strip box may contain 25 or 50 test strips packed separately for each test strip.
The Medisign Link Diabetes Management Software is an optional software accessory and were previously cleared in K133260.
The provided document is a 510(k) premarket notification for a Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and a high-level summary of performance testing.
However, the document does not contain detailed information about specific acceptance criteria for the device performance beyond stating "the performance of the candidate devices were satisfied with all pre-determined acceptance criteria." It also lacks specifics on the study design, sample sizes for test sets (beyond implicitly mentioning clinical and non-clinical tests), data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance details, type of ground truth used for performance validation, training set details, or how ground truth for the training set was established.
Therefore, I cannot provide a table of acceptance criteria with reported device performance or many of the other requested details because that specific information is not present in the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly detailed in the provided text. The document generally states "the performance of the candidate devices were satisfied with all pre-determined acceptance criteria."
- Reported Device Performance: Not explicitly detailed with specific metrics and thresholds in the provided text.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "clinical and non-clinical tests were conducted."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document.
4. Adjudication method for the test set
- This information is not provided in the document.
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 device is a Blood Glucose Monitoring System, which is an in-vitro diagnostic device, not an AI or imaging-based device involving human readers or interpretation of complex cases. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a standalone blood glucose monitoring system. The performance described would inherently be the "standalone" performance of the device itself (meter + test strip). The document implies this by stating the device was "compared with the YSI 2300 STAT Plus as a reference instrument to evaluate the system reliability and accuracy performance."
7. The type of ground truth used
- The document states: "The candidate devices were compared with the YSI 2300 STAT Plus as a reference instrument to evaluate the system reliability and accuracy performance."
- Ground Truth Type: Comparison to a Reference Instrument (YSI 2300 STAT Plus). This is a common method for establishing ground truth in glucose measurement studies, where a highly accurate laboratory analyzer serves as the comparator.
8. The sample size for the training set
- This information is not provided in the document, as the document describes validation testing against a reference, not the training of an algorithm in the AI sense.
9. How the ground truth for the training set was established
- This information is not provided in the document, as the document describes validation testing against a reference, not the training of an algorithm in the AI sense.
In summary, the provided text offers a high-level overview of the device and its regulatory submission but lacks the detailed performance study results and methodology typically found in a full study report or technical documentation.
§ 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.