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510(k) Data Aggregation
(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 < -150mmHg) Flow rate reduction due to pump segment fatigue: -10% to 0% for typical treatment duration. Inflow pressure: -150 mmHg minimum, +150 mmHg maximum. Outlet pressure: +500 mmHg maximum. Alarm Limit (Flow rate): Upper Limit: Set value +10%, Lower Limit: Set value -10% Reminder alarm (BP OFF, BP cover open, blood flow set 0): 20 seconds | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Dialysis Flow Rate | Setting range: Single ETRF 300 to 800 mL/min; Double ETRF 300 to 700 mL/min Flow rate accuracy: Set value ±10% Protective system (Ultrafiltration) Method: Monitoring of Duplex pump rate with cell; Alarm limit: Upper +10%, Lower -10% Protective system (Ultrafiltration) Method: Monitoring of Duplex pump valve leak with cell; Alarm limit: 0.7V Dialysate Flow Rates can be automatically set based on provider's prescription (optional) | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Net Fluid Removal | 0 to 4000 (mL/hr), Profiled UF | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Dialysis Time | Hemodialysis: 0 to 10 hours, time can be adjusted manually | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Dialysis Fluid Comp. | Total conductivity range (mS/cm): 12.7 to 15.2 Monitoring conductivity average accuracy: ±-0.2mS/cm Maximum concentrate deviation alarm limit: ±5% Acid Setting range: 12.7 to 15.2 mS/cm, Measurement accuracy: ±0.2 mS/cm (±2 mmol/L) Bicarbonate Setting range: 2.3 to 7.0 mS/cm, Measurement accuracy: ±0.1 mS/cm | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Dialysis Fluid Temp. | Setting range: 33.0 to 40.0°C (91.4 to 104 °F) Measurement range: 10.0 to 45.0 °C (50 to 113 °F) Measurement accuracy: Measurement value ±0.8°C (±1.4 °F) Fixed alarm limit: 41 °C (105.8 °F) Auto alarm limit: Set value +1 °C (+1.8 °F), Lower limit: Set value -1 °C (-1.8 °F) | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Heparin Delivery Rate | Setting range: 0.0 to 9.9 mL/h Output rate accuracy: Set value ±10% Back pressure: +500 mmHg Alarm limit: Upper +20%, Lower -20% | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Blood Volume Monitor (BVM) | dBV monitoring accuracy: ±2.3dBV% (Double needle) | Implied to meet this specification as part of clearance. No specific measured values reported. |
| Blood Pressure Monitor (BPM) | Pressurization-type: Pressure display accuracy: Less than ±3 mmHg Blood Pressure measurement accuracy: Conform to ISO 81060-2:2018/Amd.1:2020 Average within ±5mmHg, Delta standard deviation within 8 mmHg. Pulse rate accuracy: ±2% or ±2 beats (whichever is greater) Depressurization-type: Pressure display accuracy: Less than ±3 mmHg Blood Pressure measurement accuracy: Conform to ISO 81060-2:2018/Amd.1:2020 Average within ±5mmHg, Delta standard deviation within 8 mmHg. Pulse rate accuracy: ±2% or ±2 beats | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Daily Dose Monitor (DDM) | Kt/V monitoring accuracy: ±0.1 (Kt/V 0 to 1) ±10% (Kt/V 1 to 3) URR monitoring accuracy: ±5% | Implied to meet these specifications as part of clearance. No specific measured values reported. |
| Sterilization (EF-02D) | Sterility Assurance Level (SAL) of 10⁻⁶ | "Validated to ensure the appropriate Steility Assurance Level (SAL) of 10⁻⁶". No specific log reduction or sterility test result values are provided. |
| Bacterial Retention (EF-02D) | Capable of producing ultrapure dialysate from spiked dialysis fluid, exceeding allowable limit of < 100 CFU/mL (ANSI/AAMI ISO23500-5:2019) | Verified that the filter "can produce ultrapure dialysate". No specific CFU/mL reduction reported. |
| Endotoxin Retention (EF-02D) | Capable of producing ultrapure dialysate from spiked dialysis fluid, exceeding allowable limit of < 0.5 EU/mL (ANSI/AAMI ISO23500-5:2019) | Verified that the filter "can produce ultrapure dialysate". No specific EU/mL reduction reported. |
Regarding AI/Algorithm-Specific Questions (2-7):
The provided text does not contain any information related to an AI/algorithm for diagnostic or prognostic purposes, and therefore, these questions cannot be answered from the given document. The software mentioned "controls the machine during hemodialysis treatment" rather than performing analytical or interpretive tasks characteristic of AI in medical imaging or diagnostics.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This is a physical device, not a diagnostic AI.
- 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): Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
Regarding Training Set Information (8-9):
The document mentions "Software Verification and Validation Testing" but does not describe a "training set" in the context of machine learning or AI. The software is for controlling the hemodialysis machine's functions.
- The sample size for the training set: Not applicable. The software performs control functions for the machine, not an AI model that requires a training set of data.
- How the ground truth for the training set was established: Not applicable for the same reasons as above. The software is validated against functional requirements and design specifications, not against a "ground truth" for a learned AI task.
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