(70 days)
The T-REX™ biopsy forceps are intended to obtain endomyocardial biopsy specimens. The specimens are taken for diagnosis of diseased heart tissue or for identification and monitoring of rejection factors in a transplanted heart.
The T.REX™ forceps are designed to allow percutaneous access to the right or left ventricles of the heart in order to obtain diagnostic tissue samples. The forceps consist of three main components: a handle ergonomically designed for comfortable use, a body and surgical stainless steel cutting jaws.
The provided text is a 510(k) summary for the T-REX™ Biopsy Forceps. It describes the device, its intended use, and compares it to a predicate device (Bycep® biopsy forceps). However, it does not include specific acceptance criteria or a detailed study proving the device meets them in the way a clinical trial report would.
The document focuses on demonstrating substantial equivalence to a previously approved predicate device (Bycep® biopsy forceps) through comparing design modifications and conducting bench testing and biocompatibility evaluations. It explicitly states that clinical studies were not conducted.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of metrics like sensitivity, specificity, or accuracy, as these are usually derived from clinical studies with defined endpoints.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
As clinical performance metrics are not provided, this table focuses on the types of performance evaluated and the overall conclusion of the substantial equivalence claim.
| Acceptance Criteria Category | Reported Device Performance / Evaluation Outcome |
|---|---|
| Cutting Ability | Comparative testing confirmed T-REX™ forceps are "capable of performing the intended function of biopsy forceps, which is to obtain samples of myocardium." |
| Tensile Strength | Testing included modified joints and overall tensile strength. "Testing confirmed the T-REX™ forceps met its design specifications." |
| Biocompatibility | Evaluated for material characterization, cytotoxicity, pyrogenicity, and hemocompatibility. "The T.REXTM forceps were found to be compatible with biological systems." |
| Sterility | EtO sterilization achieved a Sterility Assurance Level (SAL) of 10⁻⁶. "The T.REX™ forceps are nonpyrogenic." |
| Packaging Integrity | "Sterilization and packaging testing confirmed the proposed packaging will protect the product and maintain sterility." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the in vitro (bench) tests. The document mentions "comparative testing" and "testing included modified joints and the overall tensile strength of complete devices" but does not give numerical sample sizes for these tests.
- Data Provenance: All testing appears to be in vitro (bench testing) performed by Boston Scientific Corporation Northwest Technology Center, Inc. There is no mention of geographical data provenance as the data is from laboratory testing, not human subjects. It is retrospective in the sense that it's comparing a new design to an existing one, but the data itself is from newly performed bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies described are in vitro bench tests (mechanical, material, and sterility evaluations), not clinical studies involving expert interpretation of patient data or samples.
- Ground truth for mechanical properties would be engineering specifications and measurements.
- Ground truth for biocompatibility would be established by validated laboratory protocols and expert toxicologists/biocompatibility specialists interpreting the results against established standards (e.g., ISO 10993).
- Ground truth for sterility would be established by microbiological testing and validation against SAL standards.
4. Adjudication Method for the Test Set
- Not applicable, as no human-based assessment or adjudication of a "test set" (e.g., diagnostic images or clinical outcomes) occurred. The assessments were based on engineering measurements and laboratory results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done.
- The document explicitly states: "Clinical studies were not conducted on the T.REX™ forceps."
- Therefore, an effect size of human readers improving with or without AI assistance cannot be provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a manual biopsy forceps, not an AI algorithm or a device with an automated algorithm. The performance described relates to the physical characteristics and function of the forceps itself.
7. Type of Ground Truth Used
- For cutting ability and tensile strength: Engineering specifications, direct physical measurements, and comparison to the predicate device's measured performance.
- For biocompatibility: Results from validated laboratory assays (cytotoxicity, pyrogenicity, hemocompatibility) interpreted against established biocompatibility standards.
- For sterility: Microbiological testing and validation against a Sterility Assurance Level (SAL) of 10⁻⁶.
- For packaging: Testing to confirm protection and sterility maintenance (details not provided on specific ground truths, but likely industry standards for package integrity).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical medical device.
§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).