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The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

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 COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. The COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines.

This 510(k) submission (K080116) for the Transonic COstatus System surprisingly does not include any explicit acceptance criteria or a detailed study section demonstrating the device's performance against such criteria. Instead, the submission relies heavily on a claim of substantial equivalence to predicate devices (K023960 and K980906) and general statements about internal testing and manufacturing processes.

Therefore, many of the requested sections about specific study design parameters cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned. No specific test set for performance evaluation is described.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable, as there's no mention of a clinical or expert-validated test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no test set requiring ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, nor does it mention evaluating human reader improvement with or without AI assistance. The device is a diagnostic computer for cardiovascular status, not an AI-assisted diagnostic imaging or interpretation tool in this context.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No specific standalone performance study comparing the algorithm's output to a ground truth with quantitative metrics is described. The device is described as an "apparatus using an indicator dilution technique" to measure fluid volumes, implying a direct measurement system rather than a complex algorithm whose standalone performance would typically be evaluated in isolation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated or described. The document refers to "product design specifications" for performance parameters, but not how these were validated externally or against an established ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is not described as an AI/ML product that undergoes a "training" phase.

9. How Ground Truth for Training Set Was Established

• Method for Establishing Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model.

Summary of the Study:

Based on the provided text, the submission for the Transonic COstatus System does not describe a traditional clinical performance study with explicit acceptance criteria, a defined test set, or a ground truth established by experts. Instead, the entire submission hinges on demonstrating substantial equivalence to two predicate devices:

• K023960: LiDCOplus Hemodynamic Monitor
• K980906: Transonic Hemodialysis Monitor, Cardiac Output (Measurement)

The primary "study" or evidence presented for safety and effectiveness is through this comparison, highlighting:

• Similar Materials, Form, and Intended Use: The COstatus System is stated to be similar to the HD01 (K980906) in these aspects.
• Mechanism of Action: Both the COstatus and the HD01 use an indicator dilution technique. The COstatus differs from the HD01 by using a peristaltic pump instead of a hemodialysis circuit, allowing for use on any patient with arterial and venous lines.
• Comparison to LiDCOplus (K023960): The COstatus also uses a peristaltic pump like the LiDCOplus, but uses saline as an indicator instead of lithium chloride. Crucially, the COstatus runs as a closed loop, returning drawn blood to the patient, unlike the LiDCOplus which does not.
• Conclusion on Differences: The submission states that these differences "do not raise any new issues of safety or effectiveness regarding the Transonic COstatus System."
• Internal Testing: The document mentions that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination" to ensure performance parameters conform to "product design specifications." However, these specifications and specific results are not detailed.

In essence, the "study" proving the device meets criteria is primarily the argument for substantial equivalence based on engineering design comparison and internal product quality control, rather than a clinical trial with performance metrics.

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Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.

Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of access site stenosis for individual hemodialysis patients. Vasc-Alert utilizes measurements routinely collected during a dialysis treatment by the hemodialysis machine, such as pressure and flow rate, and applies a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test to these measurements. The average VAPR test result for each treatment session is stored in a Vasc-Alert database. If a patient has a high reading in three consecutive dialysis sessions, a report is issued to the medical staff indicating that the patient should be examined more closely for the onset of stenosis. Hemodialysis center personnel can use the report as a tool to proactively monitor for incipient stenosis and prompt proactive intervention to avoid site closure.

Vasc-Alert comprises five main components or modules:

• A module for recording, transferring and parsing data collected by dialysis center machines.
• A module for calculating the VAPR values from treatment data.
• A module for identifying significant patterns in the calculated VAPR data that will prompt an alert (i.e., 3 high readings in a row for a patient).
• A module for generating reports and sending these out to center personnel.
• An internet-based data input module.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets these criteria. The document is a 510(k) summary for the Vasc-Alert device, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study report.

However, based on the narrative, we can infer some aspects and highlight what information is missing:

Inferred Information:

The core function of Vasc-Alert is to identify an "increased risk of access site stenosis" when a patient has a "high reading in three consecutive dialysis sessions" based on the Vascular Access Pressure Ratio (VAPR) test. The "study" mentioned isn't a formalized clinical trial with defined endpoints and acceptance criteria, but rather a "side-by-side testing" for substantial equivalence.

Here's an attempt to structure the information based on your request, noting significant gaps:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria: There are no defined thresholds for sensitivity, specificity, positive predictive value, negative predictive value, or accuracy for identifying "at risk" patients or predicting complications.
• Detailed performance metrics: Beyond the qualitative statements, no numerical data (e.g., exact percentages of patients identified, or precise proportion of those who developed complications) is provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document only refers to "side-by-side testing" without providing the number of patients or dialysis sessions included.

Data Provenance: Not specified. It doesn't mention the country of origin, whether the data was retrospective or prospective, or from how many centers.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Number of Experts: Not specified.

Qualifications of Experts: Not specified. The phrase "medical staff" is used when referring to who examines the patient after an alert, but it's unclear if these or other experts were involved in establishing the ground truth for the "side-by-side testing."

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no information about how the "complications" were confirmed or how ground truth was established for the "side-by-side testing."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not reported. The device is software that generates alerts, and the text describes its standalone performance and comparison to other technologies, not a human-AI comparison.

Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, a standalone (algorithm only) performance was implicitly reported as the "side-by-side testing" where Vasc-Alert identified patients at risk and predicted complications within 3 months. The software's ability to trigger an alert based on VAPR readings in three consecutive sessions constitutes its standalone performance.

Missing Information: Quantitative results for this standalone performance (e.g., sensitivity, specificity, predictive values).

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used for performance inference was outcomes data, specifically whether "complications in their access sites" developed within 3 months after Vasc-Alert identified them as "at risk." This implies clinical diagnosis of stenosis or related complications.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document describes the algorithm as "a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test," implying the algorithm itself was developed or validated prior to this submission, but does not provide details on Vasc-Alert's specific training set if any machine learning was involved (which is unlikely given the description of a fixed algorithm).

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not specified. Since the VAPR algorithm is stated to be "previously published," the details of its development and the establishment of ground truth for its initial formulation are outside the scope of this 510(k) summary. No specific training data or ground truth establishment for Vasc-Alert's software implementation is detailed.

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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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