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The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD01 (HD01PMS and HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HD01046 and HD02 systems. The HD01-CO Hemodialysis Monitor for Cardiac Output (HD01P05 and HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Syringe Warmer as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). The HD01-CO Hemodialysis Monitor for Cardiac Output requires the user to make a 30cc injection of ~ body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer will provide the user a convenient source of the 30cc injection of ~ body temperature saline for this injection.

The provided text describes a 510(k) premarket notification for the Transonic Syringe Warmer, an accessory device. The information primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance metrics in a quantitative manner typical for AI/ML device submissions.

Based on the provided text, I can infer the general nature of the "acceptance criteria" and "study" as implied by the FDA's "Safety and Effectiveness" section, but there are no specific numerical thresholds or detailed study results. The submission relies on demonstrating the device is similar to a predicate device and meets general quality control requirements.

Here's an analysis based on the provided text, attempting to address your points as much as possible, while noting where information is absent for this type of submission:

Acceptance Criteria and Study for the Transonic Syringe Warmer

The Transonic Syringe Warmer is an accessory device intended to warm a 30cc syringe of saline to approximately body temperature for injection into a hemodialysis blood circuit. The acceptance criteria and supporting "study" described are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device, rather than a quantifiable performance study against specific metrics for AI/ML devices.

1. A table of acceptance criteria and the reported device performance

Based on the document, the acceptance criteria are implicitly tied to "release specifications" and "product design specifications." The "reported device performance" is essentially that the device functions as intended to warm saline.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a typical AI/ML study with data points. Instead, it refers to "all finished products" being tested.

• Sample Size: "All finished products" are tested. This implies a 100% inspection or testing of manufactured units.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer, Transonic Systems Inc. (located in Ithaca, NY, USA).
• Retrospective/Prospective: Not applicable. These are manufacturing quality control tests, not clinical studies.

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 submission described. There is no mention of experts establishing ground truth for a test set, as this is a hardware device undergoing manufacturing quality control rather than a diagnostic AI/ML algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The testing described is internal quality control.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices, not for a syringe warmer. There is no AI component mentioned in this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This device is a hardware accessory and does not contain an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on its adherence to manufacturing specifications and its ability to perform its stated function (warming saline to ~body temperature). This would be validated through engineering measurements and quality control checks, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device does not use machine learning or have a "training set."

9. How the ground truth for the training set was established

Not applicable. This device does not use machine learning or have a "training set."

Summary of the "Study" Described:

The "study" demonstrating the Transonic Syringe Warmer meets its acceptance criteria is best described as a comprehensive quality control and manufacturing testing process rather than a clinical trial or AI performance study.

• Process: "All finished products are tested and must meet all required release specifications before distribution."
• Testing Types: "physical testing, visual examination (in process and finished product)."
• Methodology: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications."
• Documentation: "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP's."

The submission primarily relies on demonstrating substantial equivalence to a predicate device (Vista Dental Anesthetic Syringe Warmer) and asserting that the modified intended use (warming saline for hemodialysis monitoring) "does not raise any new issues of safety or effectiveness." This approach underscores that the primary evidence for this particular 510(k) submission is related to manufacturing quality and equivalence, not advanced performance metrics or clinical study data.

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