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510(k) Data Aggregation
(162 days)
HOME DIALYSIS PLUS
The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.
The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.
This document is a 510(k) summary for the Tablo™ Cartridge, a blood tubing set used for hemodialysis. It does not present a study proving the device meets acceptance criteria in the way one might expect for a clinically-oriented AI/software device. Instead, it describes performance testing to demonstrate substantial equivalence to a predicate device for a hardware medical device.
Therefore, many of the requested fields (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be common for AI/software devices. Instead, it lists types of performance testing and a general conclusion of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | Met all performance specifications. The minor differences in technological characteristics (organizer, inner diameter of blood pump segment, access point configuration, pressure measuring component) did not raise new or different questions of safety or effectiveness. |
| Biocompatibility Testing | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Packaging and Shelf Life Testing | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Sterilization Validation | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Pyrogenicity Testing (for blood fluid path) | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Applicable Standards and FDA Guidance Documents | Complies with applicable standards and FDA Guidance Documents. |
| Substantial Equivalence | Determined to be substantially equivalent to the Fresenius Blood Tubing Set (K120823). |
2. Sample size used for the test set and the data provenance
This information is Not Applicable to this document as it describes testing of a physical medical device (blood tubing set) rather than an AI/software device with a distinct "test set" of data. The testing mentioned would involve laboratory and engineering tests on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is Not Applicable. Ground truth, in the context of expert review for medical images or data, is not relevant for the performance testing described for a blood tubing set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is Not Applicable. Adjudication methods are typically used for expert consensus on ambiguous cases in the context of diagnostic AI/software.
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 information is Not Applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a physical device like a blood tubing set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is Not Applicable. There is no algorithm discussed for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is Not Applicable. The "ground truth" for the performance of a blood tubing set would be established by validated engineering specifications, material standards, and functional requirements rather than medical expert consensus or pathology.
8. The sample size for the training set
This information is Not Applicable. Training sets are relevant for machine learning algorithms, which are not described in this submission for a physical medical device.
9. How the ground truth for the training set was established
This information is Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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(160 days)
HOME DIALYSIS PLUS
The Tablo™ System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trailable as needed who is considered competent in the use of the device by the prescribing physician.
The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration. The Tablo Console consists of a conventional Dialysis Delivery System (DDS; Upper Module) and a compact Water Purification System (WPS; Lower Module). The Dialysis Delivery System (Upper Module) and the Water Purification System (Lower Module) are stacked and latched together to form a single integrated Console.
The provided text is a 510(k) summary for a medical device called the Tablo Console. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy for a diagnostic device).
Instead, it describes general performance testing that was conducted to ensure the device functions as intended and complies with relevant standards and guidance documents. This type of regulatory submission often focuses on demonstrating safety and effectiveness compared to an existing device, rather than presenting a performance study with acceptance criteria in the context of, for example, a diagnostic AI model.
Therefore, many of the requested fields cannot be directly extracted from this document as the information is not present. I will fill in what can be inferred or explicitly stated based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Acceptance Criteria (Stated or Inferred) | Reported Device Performance (Stated or Inferred) | Details |
|---|---|---|---|
| General Performance | Met all performance specifications. | The Tablo Console meets all performance specifications, complies with applicable standards and FDA Guidance Documents. | General statement about overall device function. |
| Disinfection | Functionality of heat and chemical disinfections. | Performance testing done for heat and chemical disinfections. | Confirms the disinfection methods work as intended. |
| Water Quality | Production of treated water of specified quality. | Performance testing done for treated water quality. | Ensures water used for dialysis meets standards. |
| Dialysate Quality | Production of dialysate of specified quality. | Performance testing done for dialysate quality. | Ensures dialysate used for dialysis meets standards. |
| Key Functions/Features | Proper functioning of all key functions, design features, and components. | Performance testing done for all key functions/design features/components. | Verifies all parts of the device operate correctly. |
| Electrical Safety | Compliance with electrical safety standards. | Testing to confirm compliance with electrical safety standards. | Ensures device is electrically safe. |
| Electromagnetic Safety | Compliance with electromagnetic safety standards (RF emissions Class B). | Testing to confirm compliance with electromagnetic safety standards. The rating for the Subject Device is Class B. | Ensures device operates without harmful electromagnetic interference and meets specified class. |
| Alarms & Alerts | Proper functioning of alarms and alerts. | Performance testing done for alarms and alerts. | Verifies safety mechanisms are functional. |
| Software | Proper functioning of software. | Performance testing done for software. | Ensures software controls and functions correctly. |
| Touchscreen | Proper functioning of touchscreen. | Performance testing done for the touchscreen. | Ensures user interface works as intended. |
| Fluid Path Materials | Suitability/safety of fluid path materials. | Testing of the fluid path materials. | Confirms materials in contact with fluids are appropriate. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., for an AI algorithm). The performance testing described refers to engineering verification and validation of the physical device and its components. Therefore, information about sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of device and performance testing described. Ground truth established by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is being benchmarked or replicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the type of device and performance testing described. Adjudication methods are usually for expert consensus on diagnostic 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Tablo Console is (it's a hemodialysis system).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to an AI algorithm's performance, which is not applicable to the Tablo Console.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be engineering specifications, validated safety standards, and functional requirements. For example, the ground truth for "treated water quality" is defined by specific chemical and microbiological standards for water used in hemodialysis. The document indicates testing was done "in accordance with appropriate FDA guidance documents and relevant standards."
8. The sample size for the training set
This information is not applicable. The Tablo Console is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device does not use a training set as it is not an AI algorithm.
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