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510(k) Data Aggregation
(88 days)
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure
Cardiogenic shock
Unstable refractory angina
Impending infarction
Mechanical complications due to acute myocardial infarction
Ischemic related intractable ventricular arrhythmias
Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
Septic shock
Weaning from cardiopulmonary bypass
Interoperative pulsatile flow generation
Support for failed angioplasty and valvuloplasty
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
The provided text describes a 510(k) premarket notification for a medical device, the Datascope 8Fr. Co-Lumen (CL) Intra-Aortic Balloon (IAB) & Accessories. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or AI/software.
Therefore, the information typically expected for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device is not applicable or available in this document. This submission is for a physical medical device (Intra-Aortic Balloon) seeking clearance based on its similarity to existing cleared devices, not on a performance study against predefined numerical acceptance criteria.
However, I can extract the relevant information from the document that addresses the spirit of your questions as much as possible within the context of a 510(k) for a physical medical device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are generally that the new device must be "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "reported device performance" is a demonstration that this equivalence holds.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use: Device intended for same indications as predicate devices. | The device's indications for use are substantially equivalent to predicate devices (listed on page 7). |
| Technological Characteristics: Differences in material composition and dimensional specifications do not affect safety or efficacy. | Differences in material composition and dimensional specifications have been demonstrated not to affect safety or efficacy of the device. (Page 4) |
| Performance/Functionality: Functionality and performance comparable to currently marketed devices. | Results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices. (Page 4) |
| Safety: Device is as safe as legally marketed predicate devices. | Implicitly demonstrated through substantial equivalence claim and in-vitro testing. (Page 4) |
| Effectiveness: Device is as effective as legally marketed predicate devices. | Implicitly demonstrated through substantial equivalence claim and in-vitro testing. (Page 4) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "in-vitro tests" but does not detail the sample size or provenance of data for these tests. For a physical device 510(k), these tests are typically benchtop or mechanical tests, not clinical performance studies with patient data.
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 information is not applicable/provided. The concept of "ground truth" established by experts for a test set is typically relevant for diagnostic or AI/software devices where expert interpretation is part of the validation. For this physical IAB, the "ground truth" would be established by engineering specifications and in-vitro test results comparing against predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary mode of evaluation for this physical device in a 510(k) context.
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. An MRMC study is designed for evaluating diagnostic devices, especially those with AI components, and the impact of AI on human reader performance. This submission is for a physical Intra-Aortic Balloon and does not involve AI or human readers for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This question pertains to AI/software performance. The device is a physical intra-aortic balloon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "in-vitro tests" (Page 4). The "ground truth" for demonstrating substantial equivalence for a physical device like an IAB would primarily be based on engineering specifications, material science standards, and established performance characteristics of the predicate devices as measured through these in-vitro tests. There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for the 510(k) submission itself, though clinical outcomes from general use of IABs would underpin the predicate devices' prior clearances.
8. The sample size for the training set
This information is not applicable. The device is 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 information is not applicable. As it's not an AI/ML device, there is no training set or ground truth in that context.
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(90 days)
The SCIMED Quest Floppy and Moderate Support Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The Quest Floppy and Moderate Support Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The SCIMED Quest Floppy and Moderate Support Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy and Moderate Support. The distal two centimeters of both models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip.
Acceptance Criteria and Study for SCIMED® Quest™ Guide Wires
Based on the provided document, the "performance" of the device is assessed through "Non-Clinical Test Summary" which lists various physical and mechanical properties. The acceptance criteria are implicit in the successful completion of these tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Adequate tip tensile strength | Testing and evaluation of the guide wires included tip tensile strength. (Implies successful testing, as the device received clearance.) |
| Adequate tip torsion strength | Testing and evaluation of the guide wires included tip torsion strength. (Implies successful testing, as the device received clearance.) |
| Adequate combined load strength | Testing and evaluation of the guide wires included combined load strength. (Implies successful testing, as the device received clearance.) |
| Adequate tip flexibility | Testing and evaluation of the guide wires included tip flexibility. (Implies successful testing, as the device received clearance.) |
| Acceptable tip prolapse characteristics | Testing and evaluation of the guide wires included tip prolapse. (Implies successful testing, as the device received clearance.) |
| Adequate J-tip curve retention (for J-tip models) | Testing and evaluation of the guide wires included J-tip curve retention. (Implies successful testing, as the device received clearance.) |
| Acceptable torque response | Testing and evaluation of the guide wires included torque response. (Implies successful testing, as the device received clearance.) |
| Adequate proximal spring coil joint shear strength | Testing and evaluation of the guide wires included proximal spring coil joint shear strength. (Implies successful testing, as the device received clearance.) |
| Compatibility with PTCA catheters and wire movement | Testing and evaluation of the guide wires included PTCA catheter compatibility/wire movement. (Implies successful testing, as the device received clearance.) |
| Adequate lubricious coating adherence | Testing and evaluation of the guide wires included lubricious coating adherence. (Implies successful testing, as the device received clearance.) |
| Satisfactory Shelf Life (ongoing) | Shelf Life testing is currently being conducted and will be submitted when it is completed. (This indicates that full shelf life data was not available at the time of this submission but was considered an ongoing requirement.) |
| Use of same materials and construction methods as predicates | The SCIMED Quest Floppy and Moderate Support Guide Wires utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires). (This is a key component of substantial equivalence.) |
| Not intended for use in the cerebral vasculature | The device's intended use explicitly excludes the cerebral vasculature. (This is a limiting factor for device application, not a performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "Non-Clinical Test Summary." It mentions "testing and evaluation of the guide wires," which generally implies a sufficient number of samples were tested to demonstrate robust performance for each characteristic.
The data provenance is prospective as the testing was conducted on the physical device itself for the purpose of demonstrating its safety and effectiveness for a 510(k) submission. There is no information regarding the country of origin of the data, but it can be inferred that the testing was performed by the manufacturer, SCIMED Life Systems, Inc., which is based in Maple Grove, MN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this type of device and study. The "Non-Clinical Test Summary" describes physical and mechanical property testing, not subjective assessments by experts. The "ground truth" for these tests would be objective measurements against defined engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved objective physical and mechanical measurements, an adjudication method for different expert opinions would not be relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The SCIMED Quest Guide Wires are interventional devices, and their performance is assessed through physical and mechanical testing, not by comparing human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable. The SCIMED Quest Guide Wires are physical medical devices, not algorithms or AI. Therefore, the concept of "standalone performance" for an algorithm is irrelevant in this context.
7. The Type of Ground Truth Used
The ground truth used for the "Non-Clinical Test Summary" was based on objective engineering and material science specifications and established testing methodologies. For example:
- Physical measurements: For parameters like tip flexibility, torque response, etc.
- Mechanical strength standards: For tensile strength, torsion strength, shear strength.
- Material properties: For coating adherence and compatibility.
- Predicate device performance: The document explicitly states that the device "utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires)," implying that the predicate devices set a benchmark for acceptable performance.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or testing of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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