(91 days)
LTM-RC Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.
LTM-RC is intended for single patient, one time use only.
The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.
The provided text describes the 510(k) summary for the LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh. This is a medical device application, and as such, the "acceptance criteria" and "device performance" are typically framed in terms of substantial equivalence to predicate devices rather than meeting specific numerical performance targets like AI algorithms. The "study" here refers to the testing conducted to demonstrate this substantial equivalence.
Here's an analysis based on the provided document:
1. Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" is essentially demonstrating substantial equivalence to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and functions equivalently.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device is safe for use in the human body. | "The data indicate that the device is biocompatible." |
| Viral Inactivation: Manufacturing process inactivates viruses. | "The manufacturing process is capable of inactivating any viral components." |
| Biomechanical Strength: Sufficient strength and suture retention for intended use. | "The biomechanical data show that the LTM-RC matrix possesses sufficient strength and suture retention for the intended use." |
| Equivalence to Predicate Devices: Same intended uses, similar indications, technological characteristics, and principles of operation. | "LTM-RC is substantially equivalent... LTM-RC has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as these predicate devices. Performance data demonstrate that LTM-RC functions equivalently to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the LTM-RC underwent "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing."
- Sample Size for Test Set: The specific sample sizes for these tests (e.g., number of animals, number of specimens for biomechanical testing) are not detailed in the provided 510(k) summary. This level of detail is typically found in the full technical documentation submitted to the FDA, not in the summary.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that LifeCell Corporation is based in Branchburg, NJ, USA, it is highly probable that the testing was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device is a surgical mesh, not an AI diagnostic tool that relies on expert interpretation of images. Therefore, the concept of "experts used to establish ground truth" as it applies to medical imaging is not applicable here. The ground truth for the performance tests (biocompatibility, biomechanical strength) would be established by standardized testing protocols and analytical methods, not by human interpretation in the same way.
4. Adjudication Method for the Test Set
- Again, as this is a physical medical device and not an AI diagnostic, an "adjudication method" (like 2+1 or 3+1 for discordant reads) is not applicable. The outcome of physical and biological tests is determined by objective measurements and scientific analysis, not by subjective expert consensus on ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, sometimes aided by AI) to assess human reader performance with and without assistance. The LTM-RC is a surgical mesh; its effectiveness is evaluated through its physical and biological properties and its ability to reinforce tissue, not through diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone performance study (algorithm only) was not done. This concept applies to AI algorithms and is not relevant for a physical surgical mesh product.
7. The Type of Ground Truth Used
The "ground truth" for the LTM-RC testing would be defined by validated scientific measurements and established standards in different fields:
- Biocompatibility: Established through standardized in vitro and in vivo tests (e.g., cytotoxicity assays, sensitization tests, implantation studies), with comparison to known safe materials.
- Viral Inactivation: Determined by analytical methods to detect viral particles or infer inactivation rates based on validated processes.
- Biomechanical Strength: Measured using material testing equipment (e.g., tensile testers) according to established engineering standards, providing objective quantifiable data like ultimate tensile strength or suture retention strength.
- Substantial Equivalence: Achieved by comparing the device's characteristics and performance to those of the predicate devices.
8. The Sample Size for the Training Set
- This concept is not applicable to a physical surgical mesh. A "training set" refers to data used to train machine learning models. The LTM-RC is a manufactured product; it doesn't have a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not applicable.
§ 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.