(255 days)
The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
The Tablo Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.
The provided document is a 510(k) summary for the Tablo Cartridge, a medical device used in hemodialysis. It outlines the performance data submitted to the FDA to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/machine learning device, nor does it detail acceptance criteria and a study proving an AI device's performance in the way implied by the prompt's structured questions.
Specifically, the device in question is a physical "blood tubing set" for hemodialysis, and the changes discussed are related to manufacturing processes (sterilization method) and minor design improvements. The "performance data" refers to validation tests for sterilization, shelf-life, biocompatibility, and bench performance of the physical cartridge, not the performance metrics of an AI algorithm.
Therefore, many of the questions asked in the prompt, such as "Number of experts used to establish the ground truth for the test set," "Adjudication method," "MRMC comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "How the ground truth for the training set was established," are not applicable to the information provided in this 510(k) summary.
Based on the provided document, here's what can be extracted, acknowledging that it does not fit the typical AI/ML device study format requested:
Device: Tablo® Cartridge (Hemodialysis blood tubing set)
Nature of Submission: 510(k) for a modified device (change in sterilization method from Ethylene Oxide (EO) gas to E-beam radiation, and minor design changes).
Given the nature of the device and the modification, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to the safety and performance of the physical medical device and its manufacturing process, not an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table with explicit "acceptance criteria" alongside "reported device performance" values in a quantitative, pass/fail format in terms of algorithm accuracy (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests conducted to ensure the device's safety and functionality after the modification. The acceptance criteria for these tests are implied to be compliance with relevant ISO standards, USP standards, and FDA guidance documents.
| Test Category | Implied Acceptance Criteria (Compliance with) | Reported Device Performance (Summary of Study Outcome) |
|---|---|---|
| E-Beam Sterilization Validation | ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2018, ISO 11737-2:2019, USP , ANSI/AAMI ST72:2019. (Ensuring the device is sterile post-treatment and biocompatible with human contact). | Conducted comprehensive tests including Bioburden Recovery, Bioburden Determination, Verification Dose Determination, Dose Map Study, Method Suitability Determination, and Test of Sterility. The outcome stated: "The E-beam sterilization process validation testing... was conducted in accordance with FDA guidance documents" and "complies with following standards." This implies successful validation demonstrating effective sterilization. |
| Shelf-Life Testing | ISO 11607-1:2019, ISO 11607-2:2019. (Ensuring the device maintains functionality, sterility, and package integrity over its intended shelf-life under various conditions). | Included Accelerated aging testing, Climatic conditioning testing, Gross leak detection (Bubble) testing, Seal strength (Peel) testing, Package performance testing, and Product functional testing. The outcome stated: "The shelf-life verification testing included the following tests to ensure that the Tablo Cartridge complies with the ISO 11607-1:2019 and ISO 11607-2:2019 standards." This implies successful demonstration of shelf-life stability. |
| Biocompatibility Testing | ISO 10993-1:2018. (Ensuring the device does not cause unacceptable adverse biological reactions when in contact with the patient's blood path). Specific tests: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity. | Conducted a battery of tests for an external communicating device with prolonged direct and indirect contact (>24 hours to 30 days) with the blood path. The outcome stated: "The battery of testing included the following tests and continues to be supportive for the modified device, per ISO 10993-1:2018." This implies successful demonstration of biocompatibility. |
| Bench Performance Testing | Meeting system requirements and performing as intended (Implied to be aligned with the predicate device's performance and/or internal specifications for flow rates, pressure handling, etc., relevant to hemodialysis blood tubing sets). | "Nonclinical bench performance tests were conducted to demonstrate that the Tablo Cartridge meets the system requirements and performs as intended." The outcome stated: "The performance testing demonstrates that the Tablo Cartridge meets all performance specifications and complies with applicable standards and FDA Guidance Documents." This indicates successful functional performance. |
Overall Conclusion: "The Tablo Cartridge (Modified Device) is substantially equivalent to the Predicate Device, and the minor difference between the Modified and the Predicate Device do not raise any new or different questions of safety or effectiveness."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated numerically (e.g., number of cartridges tested). For sterilization validation, often a statistically significant sample size based on standards like ISO 11137 is used, but the exact number isn't provided here. The same applies to shelf-life and bench performance testing.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. This is typical for device performance testing performed by the manufacturer, rather than clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for this device would be objective measurements and laboratory test results demonstrating physical, chemical, and biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. There's no human interpretation or subjective assessment that would require an adjudication method.
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. This is a physical medical device, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" is established through objective laboratory testing, established chemical/biological assays, and physical performance measurements against predefined specifications and internationally recognized standards (e.g., ISO, USP). It's based on empirical measurements of device properties rather than human diagnostic interpretation.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.