(53 days)
Artelon® FlexBand, FlexPatch, and FlexBand Plus Tissue Reinforcement products are intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
Artelon® FlexBand, FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
FlexBand™ and FlexBand™ Plus products are a knitted mesh made from ARTELON® fibers. Artelon® fiber is made of polycaprolactone-based polyurethaneurea. The construction permits the mesh to be cut into any desired shape or size without unraveling.
The Flexband Plus™ devices have a suture attached to each end of the ARTELON® mesh strips. The pre-loaded suture is intended to improve usability in the operating room. The sutured FlexBand™ Plus is packaged with two commercial (off-the-shelf) stainless steel passing needles. The device is supplied sterile, one product per package, in double layer peel pouch packaging.
The FlexBand™ and FlexBand Plus™ devices are available in several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm for each width.
The provided document is a 510(k) Premarket Notification from the FDA for a surgical mesh device called "FlexBand Plus." This document describes the device, its intended use, and a comparison to a predicate device ("FlexBand") to demonstrate substantial equivalence.
However, the provided text does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it detail typical metrics associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" described in this document refer to the physical and mechanical properties of the surgical mesh and its packaging, and how these perform compared to a previously cleared product.
Specifically, the "performance testing" section lists:
- Suture retention testing
- Suture strength testing
- Dimensional testing
- Transit testing
- Packaging testing
It then states that these tests were performed to ensure "risk acceptability criteria have been met and the risks have been mitigated." The conclusion notes that the "changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."
Therefore, I cannot answer most of your specific questions as they pertain to AI/ML device evaluation, as the provided document is for a traditional medical device (surgical mesh) and does not involve AI.
For the parts of your request that can be answered based on the provided document:
1. A table of acceptance criteria and the (reported) device performance
Based on the document, the acceptance criteria are not explicitly detailed in numerical form, but are implied to be "the same as the predicate device" and sufficient to "demonstrate that there are no new risks and the device is substantially equivalent" for the specific physical and mechanical tests mentioned. The document states that the testing demonstrated the device is "as safe, as effective, and performs as well as or better than the legally marketed device."
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Suture retention testing | Met current standards / benchmarks for suture retention comparable to predicate device. | "Suture retention testing, suture strength testing, and user validation testing demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Suture strength testing | Met current standards / benchmarks for suture strength comparable to predicate device. | "Suture retention testing, suture strength testing, and user validation testing demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Dimensional testing | Conformed to specified dimensions (0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm). | Not explicitly detailed in the document, but implied to be within acceptable ranges to be considered substantially equivalent to predicate, which has "the exact same sizes." |
| Transit testing | Maintained integrity and sterility after simulated transit conditions. | "Transit testing and packaging validation demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Packaging testing | Maintained critical physical properties and sterility during shipping and storage, ensuring no additional risks due to new packaging configuration (addition of backing card). | "Transit testing and packaging validation demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Risk Analysis | Conforms to ISO 14971:2012, demonstrating risks are acceptable and mitigated. | "A risk analysis was performed for the modifications done for the subject device, in accordance to ISO 14971:2012 Medical Devices – Applications of Risk Management to Medical Devices and International Life Sciences Risk Management SOP." Confirmed risks were mitigated and acceptable. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for any of the performance tests (suture, dimensional, transit, packaging). The provenance of the data is from the manufacturer, International Life Sciences DBA Artelon, and is likely prospective testing specifically conducted for this 510(k) submission. No country of origin for the data is specified, but the submitter is based in Georgia, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical mesh, not an AI/ML device requiring expert interpretation of outputs. The "ground truth" here would be the physical properties and performance of the device under mechanical/physical testing, measured by standard engineering methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation/labeling of data for AI/ML and not a physical device.
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, as this is related to AI/ML device evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is related to AI/ML device evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is based on engineering and physical testing standards, such as tensile strength, dimensional accuracy, packaging integrity, and the outcomes of a risk analysis per ISO 14971:2012.
8. The sample size for the training set
Not applicable, as this is related to AI/ML device evaluation. There is no "training set" for a physical surgical mesh in this context.
9. How the ground truth for the training set was established
Not applicable, as this is related to AI/ML device evaluation.
§ 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.