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The TrueTM Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.

This document describes a 510(k) premarket notification for the True™ Dilatation Balloon Valvuloplasty Catheter. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K133569).

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance values in a side-by-side format. Instead, it lists the types of in vitro tests performed and states that the device "met all predetermined acceptance criteria." The acceptance criteria would likely be specified in the internal test protocols.

Given the information in the document, we can infer some of the tests that would have had acceptance criteria:

Notes on "predetermined acceptance criteria": These criteria would be derived from applicable standards, guidance documents, internal test protocols, and customer input. For a 510(k) submission, the primary goal is to show the new device performs as safely and effectively as the predicate, so acceptance criteria often reflect performance parameters established for the predicate or industry standards.

2. Sample sizes 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 the sample sizes used for the "test set" (i.e., the units tested for performance). It only refers to "the subject device" and "the predicate device" in general terms. The tests listed are "in vitro tests," meaning they were conducted in a lab environment. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. Since these are in vitro tests, the concepts of retrospective/prospective clinical data are not directly applicable.

3. 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)

This section is not applicable. The document describes "in vitro tests" of a physical medical device (catheter). It does not involve human subjects, imaging data, or expert interpretations requiring a "ground truth" established by clinical experts.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of diagnostic outputs. The described tests are laboratory-based performance evaluations of a medical device.

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 section is not applicable. The submission is for a balloon valvuloplasty catheter, a mechanical device used in a medical procedure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This section is not applicable. The device is a physical catheter, not a standalone algorithm.

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

This section is not applicable. As explained in point 3, the tests concern the physical and mechanical performance of a device, not diagnostic accuracy requiring a "ground truth" in the clinical sense. The "ground truth" for these tests would be the engineering specifications and tolerances to which the device must conform.

8. The sample size for the training set

This section is not applicable. The document describes a traditional 510(k) submission for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."

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

This section is not applicable. As explained in point 8, there is no training set for this device.

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The True Dilatation Catheter is indicated for balloon aortic valvuloplasty.

The True Dilatation Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon functions by connecting an inflation device to the angled luer lock and injecting contrast/sailine into the inflation lumen; which inflates the balloon on the distal end of the catheter. The inflation device plunger is pulled back to deflate the balloon and it can then be withdrawn into the introducer for removal.

The provided text is a 510(k) summary for the True Dilatation Balloon Valvuloplasty Catheter. It describes the device, its intended use, and the functional and safety testing performed to demonstrate its equivalence to a predicate device.

Acceptance Criteria and Device Performance Study

The document does not detail specific quantitative acceptance criteria or a dedicated study that proves the device meets these criteria in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (True Dilatation Balloon Valvuloplasty Catheter, 510(k) number K121083).

The "study" in this context is the range of Functional and Safety Testing outlined, which serves to verify that the device design met its functional and performance requirements. The acceptance criteria for these tests would implicitly be the successful completion of each test without failure and within specified parameters, demonstrating that the device functions as intended and is safe.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "performance requirements" that were met through testing. The "reported device performance" is the successful completion of these tests.

Note on "Acceptance Criteria": For a physical medical device, especially for a 510(k) based on substantial equivalence, the "acceptance criteria" are generally that the device performs functionally and safely at least as well as the predicate device, and meets relevant international standards. The listed tests are how this is demonstrated.

The subsequent questions (2-9) are typically relevant for AI/ML device submissions, which involve data provenance, ground truth establishment, and clinical study designs. This document describes a traditional medical device (balloon catheter), and therefore, most of these questions are not applicable based on the provided text.

Here's why and what can be said:

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

• Not applicable in the context of AI/ML. This document describes a physical medical device (catheter). The "test set" refers to samples of the device itself undergoing various physical and chemical tests (e.g., biocompatibility, sterility, mechanical).
• Sample Size: Not explicitly stated for each test, but "representative samples of the device" were used.
• Data Provenance: Not applicable in the AI/ML sense. The "data" comes from laboratory and physical testing of device samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There is no "ground truth" in the clinical data sense for this type of device submission. The "ground truth" for physical characteristics and performance is established by standardized testing methods and material science. Experts would be involved in designing and conducting these tests (e.g., metrology, materials science, sterility assurance professionals), but their roles are not detailed as clinical "ground truth" experts.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for clinical endpoints or image interpretations. For physical device testing, results are usually definitive (pass/fail, within/outside spec).

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

• Not applicable. This is a physical medical device, not an AI/ML diagnostic tool involving human readers or interpretation of medical cases.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the AI/ML sense. For this device, the "ground truth" for its performance is established by:
  • Compliance with recognized international standards (e.g., ISO, ASTM).
  • Physical measurements and characterizations (e.g., balloon diameter variation, inflation/deflation time).
  • Results of controlled laboratory tests (e.g., biocompatibility assays, sterilization validation).
  • Comparison to the performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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