(179 days)
The CanGaroo® RM Antibacterial Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the Caroo RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.
The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.
The CanGaroo® RM Antibacterial Envelope consists of decellularized, non-crosslinked, Iyophilized extracellular matrix (ECM) and resorbable ring-shaped poly(lactide-co-qlycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for exudate. The drug-eluting polymer discs are secured between the multilaminate sheets on each side of the envelope.
The CanGaroo RM Antibacterial Envelope is intended to securely hold an implantable electronic device (IED) to create a stable environment when implanted in the body, while reducing bacterial colonization with rifampin and minocycline eluted from resorbable polymer discs in the envelope. The CanGaroo RM Antibacterial Envelope is based on the existing CanGaroo Envelope (K201313), with the addition of drug-eluting disc components with the antibiotics rifampin and minocvoline.
The CanGaroo RM Antibacterial Envelope is provided sterile in two sizes and is intended for single use in a single patient only.
The provided text is a 510(k) summary for the CanGaroo RM Antibacterial Envelope. This document describes the device, its intended use, and substantial equivalence to a predicate device, supported by performance data. However, it does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance in the typical sense of AI model testing (like accuracy, F1-score, etc.).
Instead, this document focuses on demonstrating that the device is safe and effective and performs at least as well as a predicate device through various types of non-clinical testing. The "acceptance criteria" here would be the successful completion of these tests, meeting certain pre-defined thresholds for physical, functional, antibacterial, and biocompatibility properties.
Therefore, I cannot directly provide the information in the format requested for AI/software-based device performance. The document describes a medical device (surgical mesh envelope), not an AI/software device that would typically have specific accuracy or similar metrics.
However, I can interpret the available information to address some of your points in the context of this physical medical device:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied by the successful completion of various tests. The "reported device performance" are the qualitative results of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device must be biocompatible according to ISO 10993 series and FDA guidance. | "Biocompatibility testing... was conducted on the subject device and the results indicate that the device is biocompatible per these standards. The testing included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and implantation studies." |
| Physical Characteristics: Device must meet visual and dimensional specifications. | "The subject device passed all test requirements" for "Appearance" and "Dimensional" characteristics. |
| Functional Characteristics: Device must meet seam strength specifications. | "The subject device passed all test requirements" for "Seam Strength." |
| Antibacterial Effectiveness (in vitro): Device must demonstrate bacterial reduction against tested organisms. | "Utilizing AATCC methodology, CanGaroo RM demonstrated bacterial reduction against a panel of 4 gram positive and 3 gram-negative organisms." |
| Drug Elution: Device must demonstrate appropriate drug assay and release kinetics. | "Drug assay and drug elution/release testing" was conducted. (Implied success as "The subject device passed all test requirements" mentioned broadly for bench testing.) |
| Bacterial Challenge Model (in vivo): Device must show clearance of bacteria in an animal model. | "A bacterial challenge model in rabbits showed clearance at day 7 following implantation for a panel of 3 gram positive and 3 gram negative organisms." |
| Pharmacokinetics (in vivo): Drug concentrations in vivo must be characterized. | "Pharmacokinetics, in vivo" testing was conducted. (Implied success as part of the overall conclusion that the device is safe and effective.) |
| Overall Safety and Effectiveness: The device must be as safe and effective as the predicate device and raise no new questions of safety or effectiveness. | "The results demonstrate that CanGaroo RM does not raise any new questions of safety and effectiveness." and "The CanGaroo RM device is as safe and as effective, with equivalent performance, to the legally marketed predicate device." |
2. Sample sizes used for the test set and the data provenance
- Sample Sizes: The document does not specify exact sample sizes for each test (e.g., number of animals in in-vivo studies, number of envelopes for bench testing). It uses general terms like "a panel" for organisms.
- Data Provenance: The document does not state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of pre-clinical testing for medical device clearance, these would inherently be prospective studies conducted according to specific protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this device's performance is established through objective laboratory and animal testing following standardized protocols (e.g., ISO, AATCC methods), not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data, typically in clinical trials or image labeling, not to the objective results of bench and animal testing.
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 not an AI-assisted device for diagnostic interpretation; it is a physical implantable medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to the physical and chemical properties of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Standardized laboratory tests: (e.g., AATCC 100 for antibacterial activity, physical and functional bench tests).
- Biocompatibility standards: (ISO 10993 series).
- In-vivo animal model results: (bacterial clearance, pharmacokinetics).
These are objective, empirical measures, not subjective expert consensus or clinical outcomes data in humans for this pre-market submission.
8. The sample size for the training set
Not applicable. This refers to an AI/machine learning model. This is a physical medical device; 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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.