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510(k) Data Aggregation
(130 days)
The LIM Precision Steerable TS Transseptal System is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Keystone Heart LIM Precision Steerable TS Transseptal System is a sterile, single use, tridirectional introducer. The system consists of a sheath and a dilator.
The sheath has a handle assembly with a rotating knob and steering lever that deflects the distal end of the sheath. The dilator can be inserted and advanced or retracted through the inner lumen of the sheath. Hemostasis is maintained along the dilator lumen via a hemostatic valve. The dilator lumen is flushable. Once the dilator is generally in the proper position relative to the sheath, an actuator is tightened to secure the dilator to the handle. A knob is then turned to slowly advance the dilator.
The provided text is a 510(k) summary for the Keystone Heart LIM Precision Steerable TS Transseptal System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a new device's efficacy or safety. Therefore, the information needed to directly answer many of the questions regarding acceptance criteria, study details, and ground truth is not present in the provided document.
However, I can extract what is present and indicate where the requested information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically used for diagnostic or AI-driven devices with specific quantitative performance metrics like sensitivity, specificity, etc. Instead, performance data is discussed in the context of demonstrating substantial equivalence through various engineering and biocompatibility tests.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Performance | Visual Inspection and Dimensional Analysis: Performed |
| Primary and Secondary Deflection: Performed | |
| Insertion and Removal: Performed | |
| Dilator Lock and Buckle: Performed | |
| Leak and Flush: Performed | |
| Femoral and Septal Insertion: Performed | |
| Torque Test: Performed | |
| Fluoroscopy and Ultrasound Visualization: Performed | |
| Biocompatibility | Cytotoxicity: Performed |
| Sensitization: Performed | |
| Intracutaneous Reactivity: Performed | |
| Systemic Toxicity: Performed | |
| Pyrogenicity: Performed | |
| ASTM Hemolysis (Direct and Indirect): Performed | |
| SC5b-9 Complement Activation: Performed | |
| Partial Thromboplastin Time: Performed | |
| In Vivo Thrombogenicity: Performed | |
| Usability/Clinical | Not explicitly detailed as acceptance criteria or performance metrics in this summary. |
| Safety | Not explicitly detailed as acceptance criteria or performance metrics in this summary beyond biocompatibility testing. |
Missing Information: Specific quantitative acceptance criteria (e.g., deflection angles must be within X degrees, torque must be at least Y Nm, leakage rate must be less than Z) and the numerical results demonstrating that the device met these criteria are not provided. The document only states that these tests were "performed" to "assure reliable design and performance" and provide "evidence of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "in vitro bench testing" but does not detail the number of devices or components tested for each specific test.
- Data Provenance: The tests are described as "in vitro bench testing" and "biocompatibility testing." These are laboratory tests, not human or animal studies with clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable to the provided document. The tests performed are engineering and laboratory-based (e.g., deflection, torque, biocompatibility), which do not typically involve human expert establishment of ground truth in the way medical image analysis or diagnostic AI studies do.
4. Adjudication Method for the Test Set
This question is not applicable for the reasons stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
No. The document explicitly states: "No animal or human testing was conducted on the Keystone Heart Transseptal System." Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
No. The Keystone Heart LIM Precision Steerable TS Transseptal System is a physical medical device (introducer system), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes) is not applicable here. The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties of the materials and design (e.g., a known force applied, a measured dimension, a defined biocompatibility standard).
8. The Sample Size for the Training Set
No. The device is a physical medical device. This question implies a machine learning or AI training set, which is not relevant to this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device like this introducer system.
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