(28 days)
The CanGaroo 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 CanGaroo Envelope include pacemaker pulse generators, defibrillators or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
The CanGaroo Envelope is constructed from two to four perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using violet 5-0 polydioxanone suture (PDS). The device design is identical to the device cleared under K192616.
The provided text is a 510(k) summary for the CanGaroo Envelope, a surgical mesh device intended to securely hold implantable electronic devices. This document describes a "Special 510(k)" application, which means it addresses changes to a previously cleared device (K192616), specifically regarding its packaging.
Crucially, this document does not describe a study related to acceptance criteria for an AI/algorithm-based medical device. It focuses on demonstrating that changes in the product's packaging do not alter its fundamental scientific technology, intended use, or performance. Therefore, most of the information requested in your prompt regarding AI/algorithm performance, ground truth, expert consensus, and multi-reader studies is not applicable to this document.
However, I can extract information related to the device's validation for the packaging changes:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for new packaging) | Reported Device Performance (with new packaging) |
|---|---|
| Maintain product sterility during storage and shipment. | Product manufactured with new packaging met design input requirements for packaging and sterilization. |
| Protect the product during transportation. | Product manufactured with new packaging met design input requirements for packaging and sterilization. |
| Comply with suture manufacturer's recommendations for storage. | New packaging introduced to comply with suture manufacturer's recommendations. |
| Device performance unchanged compared to predicate (K192616). | "The CanGaroo Envelope manufactured with the new packaging met the design input requirements for packaging and sterilization." "The operating principle(s) and mechanism of the device are not changing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the document. The text mentions "packaging testing and sterilization adoption testing of product manufactured with the new packaging was repeated," implying a test set was used, but the number of units tested is not provided.
- Data Provenance: Not applicable. The testing is described as non-clinical, likely internal testing performed by Aziyo Biologics, Inc.
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)
- Not applicable. This is a non-clinical, packaging-focused submission, not an AI/algorithm study requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/algorithm study requiring clinical adjudication.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document is about a physical medical device (surgical mesh envelope) and packaging changes, not an AI/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This document is about a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the packaging validation, the "ground truth" would be the pre-defined design input requirements for packaging and sterilization performance (e.g., maintaining sterility, physical integrity). These are engineering and quality control standards, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm study requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm study.
In summary: The provided text is a regulatory submission for a physical medical device (a surgical mesh envelope) specifically addressing changes to its packaging. It does not contain information about an AI/algorithm-based device, its performance, or associated studies like those you've inquired about.
§ 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.