(89 days)
Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses:
• Intracardiac Repair
► Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness).
► Atrial Repair.
• Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure.
• Pericardial Closure.
The Sulzer Carbomedics CardioFix™ Pericardium is prepared from bovine pericardium stabilized using a dye-mediated process referred to as the PhotoFix® process. This photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. The CardioFix™ Pericardium is sterilized by ethylene oxide and is supplied sterile in a sealed container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium before implantation is not required. The CardioFix™ Pericardium is available in the following sizes: 1 cm x 1 cm, 4 cm, 6 cm x 8 cm, 8 cm x 14 cm, 10 cm x 16 cm, and 14 cm x 16 cm.
The provided text describes a 510(k) submission for the Sulzer Carbomedics CardioFix™ Pericardium, focusing on its substantial equivalence to predicate devices. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria. The document is primarily a summary of the device, its indications for use, and a confirmation of 510(k) clearance by the FDA.
Therefore, I cannot fully answer your request. However, I can extract the information that is present and explain why other sections cannot be completed based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
The document mentions "Comprehensive in vitro performance testing has been performed for the Sulzer Carbomedics CardioFix™ Pericardium and Bio-Vascular Peri-Guard Pericardium predicate device." It also states, "In vitro performance testing performed for the CardioFix™ Pericardium and predicate device, which included uniaxial tension, suture retention, and suture hole elongation provides evidence that the CardioFix™ Pericardium is substantially equivalent to the predicate devices."
However, the document does not provide the specific acceptance criteria (e.g., numerical thresholds for uniaxial tension, suture retention, or suture hole elongation) or the actual numerical results ("reported device performance") for either the CardioFix™ Pericardium or the predicate device that would allow for a direct comparison against such criteria.
The acceptance criteria for 510(k) submissions are typically framed around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The "acceptance criteria" here are implied to be that the CardioFix™ performs comparably to the predicate on these tests. Without the actual data from the testing, a table cannot be completed with specific performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text for the in vitro tests.
- Data provenance: For in vitro tests, it's generally retrospective as these are lab tests done on manufactured samples. The country of origin is not specified but implicitly assumed to be from Sulzer Carbomedics Inc. which is in Austin, Texas, USA.
The document also mentions "animal testing demonstrates acceptable in vivo performance for the CardioFix™ Pericardium," and later, in the FDA letter, it states, "You also included results of rat subcutaneous implantation tests assessing calcification potential."
- Sample size for animal test set: Not specified.
- Data provenance for animal study: Animal testing (specifically rat subcutaneous implantation) as described in the text is prospective for the duration of the study, though the reporting within the 510(k) is retrospective. The country of origin is implicitly the location of Sulzer Carbomedics, Inc. (USA) or the location where their research was conducted.
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 or not provided in the context of this device and study types.
- For the in vitro performance tests (uniaxial tension, suture retention, suture hole elongation), "ground truth" is established through physical measurement according to validated test methods, not by expert consensus in the typical sense of medical imaging or clinical ground truth.
- For the animal study (rat subcutaneous implantation for calcification), "ground truth" would be established through histological analysis and quantitative assessment of calcification, typically performed by pathologists or histotechnicians, but the number and qualifications of such experts are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or not provided for the types of tests described. Adjudication methods are typically used when subjective assessments by multiple experts are involved, such as in clinical trials or image interpretation studies, to resolve discrepancies. The in vitro and animal studies described here are objective measurements or pathological assessments.
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 is not applicable. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers interpret images or data. The CardioFix™ Pericardium is a medical implant (cardiovascular patch), not a diagnostic or AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The CardioFix™ Pericardium is a medical implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in vitro performance tests: The "ground truth" is derived from physical measurements using established laboratory test methods (e.g., force transducers for tension and retention, calipers or imaging for hole elongation).
- For the animal study (calcification): The "ground truth" for calcification assessment would typically be derived from pathology/histology and potentially quantitative biochemical assays.
8. The sample size for the training set:
This is not applicable. The CardioFix™ Pericardium is a medical implant, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
Summary of what is present in the text related to the "study":
The "study" described is a set of in vitro performance tests and animal testing for the Sulzer Carbomedics CardioFix™ Pericardium, conducted to demonstrate substantial equivalence to a predicate device (Bio-Vascular Peri-Guard Pericardium).
- In vitro tests included: Uniaxial tension, suture retention, and suture hole elongation.
- Animal testing: Rat subcutaneous implantation tests assessing calcification potential. The FDA noted that "calcification development is delayed in the CardioFix™ compared to the control device," but also cautioned that the rat model is not validated for human correlation.
This document serves as a 510(k) summary, which typically provides an overview rather than the detailed methodology and results of such studies. For the specific numerical data and detailed test protocols, one would normally refer to the full 510(k) submission or supporting technical documentation, which is not provided here.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).