(89 days)
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.
The provided text describes the 510(k) premarket notification for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio, focusing on their MR Conditional labeling. It primarily details non-clinical performance testing rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with human readers.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Standard/Method | Specific Criteria/Purpose | Reported Device Performance |
|---|---|---|---|
| MR Conditional Safety | Magnetically Induced Displacement Force | ASTM F2052-14 | Assessed in MR environment |
| Magnetically Induced Torque | ASTM F2213-06 | Assessed in MR environment | |
| Radio Frequency (RF) Heating | ASTM F2182-11a | Assessed in MR environment | |
| Image Artifacts | ASTM F2119-07 | Assessed in MR environment |
Conclusion: The non-clinical performance data demonstrated that the subject devices, when exposed to the MR environment under specific MR conditions of use, did not raise new questions of safety or efficacy.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not detail a "test set" in the context of clinical or algorithmic performance. The testing described is non-clinical performance testing on the devices themselves to assess their safety in an MR environment. Therefore, information about human data provenance, sample size of a test set, etc., is not applicable to this type of study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not Applicable. As this is non-clinical performance testing for MR safety, there is no "test set" that requires expert ground truth establishment in the traditional sense of medical image analysis or diagnosis. The "ground truth" here is the physical interaction of the device with the MR environment as measured by standardized tests.
4. Adjudication Method for the Test Set
Not Applicable. There is no "test set" requiring adjudication by experts. The performance is measured against established engineering standards for MR safety.
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. The document describes non-clinical performance testing for MR safety of physical implants and wires. It does not involve any AI, human readers, or a comparative effectiveness study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document describes non-clinical performance testing of physical medical devices, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established engineering and safety standards (ASTM standards) for assessing the behavior of medical devices in a Magnetic Resonance (MR) environment. This includes:
- ASTM F2052-14 for magnetically induced displacement force.
- ASTM F2213-06 for magnetically induced torque.
- ASTM F2182-11a for radio frequency (RF) heating.
- ASTM F2119-07 for image artifacts.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/algorithm study involving a training set. The descriptions are for non-clinical performance testing of physical devices.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an algorithm, there is no ground truth established in this context.
§ 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.