(296 days)
The intended indications for use of the PICO 14 is for individuals with mild to moderate pain associated with carpal tunnel syndrome. It is designed to provide support and compression to the wrist, helping to alleviate discomfort and promote healing.
A very compact and versatile smart plug with Wi-Fi connectivity, energy monitoring, and scheduling capabilities.
The provided text describes the FDA clearance for the DBB-06 PRO Hemodialysis Delivery System. However, it does not contain detailed information regarding acceptance criteria for specific device performance metrics (e.g., sensitivity, specificity, accuracy) nor does it describe specific studies that prove the device meets such criteria in the context of an AI/algorithm-driven medical device.
The document focuses on:
- Safety and Performance of a Physical Hemodialysis Machine: It outlines various engineering specifications, material compatibility, sterilization validation, electrical safety, and software verification for a hemodialysis delivery system.
- Substantial Equivalence: The primary goal of the 510(k) submission is to demonstrate that the DBB-06 PRO is substantially equivalent to predicate devices (DBB-06 Hemodialysis Delivery System and 2008T Bluestar Hemodialysis Machine).
- General Performance Testing: The "Performance – Bench Testing" section lists various types of tests conducted (e.g., "System Level Performance Testing," "Disinfection Validation Testing," "Bacterial Retention Testing"), but it does not provide acceptance criteria for these tests nor the specific performance results in a way that would allow for the population of the requested table for an AI model.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a physical medical device (hemodialysis machine) rather than an AI-driven diagnostic or prognostic algorithm. Specifically, sections 1-7 of your request are not applicable as presented because there is no AI/algorithm being evaluated for diagnostic or prognostic performance with associated metrics like sensitivity, specificity, or reader studies.
The document does mention "Software controls the machine during hemodialysis treatment" and "Software Verification and Validation Testing," indicating software components are present, but these are for controlling the machine's operation, not for diagnostic interpretation or prediction in an AI context.
Here's what can be extracted, and where limitations exist:
1. Table of Acceptance Criteria and Reported Device Performance
- Limitation: The document provides "Key Performance Characteristics" (Table 1) for various mechanical and electrical aspects of the hemodialysis machine. These are specifications (e.g., "Flow rate accuracy: Set value ±10%") rather than acceptance criteria for an AI model's diagnostic/prognostic performance (like sensitivity, specificity, AUC). No reported performance results against specific acceptance criteria for AI are available.
| Feature | Acceptance Criteria (Specification/Characteristic) | Reported Device Performance |
|---|---|---|
| Blood Pump | Setting range: 40 to 600 mL/min (ID 8.0mm) | |
| Flow rate accuracy: Set value ±10% (Inflow Pressure –150mmHg ≤ P ≤ +150mmHg); Set value -20 to 0% (Inflow Pressure -200mmHg ≤ P |
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”