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510(k) Data Aggregation
(202 days)
ORTHEON MEDICAL, LLC.
The Ortheon Medical Teno Fix™ tendon repair system is indicated for the repair of severed or lacerated digital flexor tendons.
The Teno Fix™ Tendon Repair System is delivered sterile. It consists of the implantable stainless steel components, implantation accessories, and installation instruments. The implantable components of the device include the anchors, stop beads, and suture. The stainless steel suture is shipped pre-assembled with a crimped stop bead and tapered needle.
The Teno Fix™ Tendon Repair System is supplied with two preloaded, single-use disposable installation instruments for implantation of the Teno Fix™ anchors. A crimping instrument is supplied to crimp the stop bead to the stainless steel core suture thus controlling the overall length of the implanted device.
Here's a breakdown of the acceptance criteria and study information for the Ortheon Medical Teno Fix™ Repair System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list numerical acceptance criteria in terms of performance metrics (e.g., tensile strength, healing rates). Instead, the acceptance criteria are framed in terms of meeting recognized standards and demonstrating substantial equivalence to predicate devices, as well as being safe and effective.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Standards | ASTM F899-95 | Meets the requirements of the stated standard. |
| ASTM F138-00 | Meets the requirements of the stated standard. | |
| Sterilization | ANSI/AAMI/ISO 11137-1994 | Meets the requirements of the stated standard. |
| Technological Characteristics | Similar to predicate devices (Surgical Stainless Steel Sutures by Ethicon and Peters Pharmaceutical Laboratory, Prolene sutures by Ethicon). | Eleven (11) technological characteristics were compared and found to be similar to predicate devices. |
| Biocompatibility | Substantial equivalence to predicate devices, demonstrated through comparative testing. | Demonstrated in canine studies, showing biocompatibility of materials. |
| Implant Stability | Substantial equivalence to predicate devices, demonstrated through comparative testing. | Demonstrated in canine studies, showing stability of the implant within the tendon. |
| Healing Improvement | Ability to improve healing of the injury over predicate devices by reducing the gap between severed ends of the tendon. | Demonstrated in canine studies. |
| Overall Performance | Performs as well or better than predicate devices. | Shown through clinical study in humans. |
| Safety & Effectiveness | Safe and effective for its intended use. | Shown through clinical study in humans. |
| Design Control | Designed and developed utilizing design control methods in compliance with 21CFR820. | Complies with 21CFR820. |
| Manufacturing | Manufactured per specifications and good manufacturing practices. | Manufactured per specifications and good manufacturing practices to ensure safety and effectiveness. |
| Predicate Equivalence | Substantially equivalent to listed predicate devices for regulatory purposes. | FDA determined the device is substantially equivalent to legally marketed predicate devices (K931271, K991073, and reclassified Prolene sutures). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Canine Studies: Not explicitly stated, but "comparative testing in canines" is mentioned.
- Human Clinical Study: Not explicitly stated. The document only mentions "Results of a comparative clinical study in humans."
- Data Provenance: The document implies both animal (canine) and human clinical data were used. The country of origin for the studies is not specified. The studies appear to be prospective, as they are referred to as "comparative bench testing," "comparative testing in canines," and "comparative clinical study in humans" to demonstrate equivalence and performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "clinical study" results but does not detailing the study design, including the number or qualifications of experts involved in establishing ground truth or evaluating outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document. The document refers to "clinical study" results but does not detailing the study design, including any adjudication methods employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study is not indicated. The document refers to a "comparative clinical study in humans" demonstrating the device performs "as well or better than the predicate devices" and "is safe and effective." However, it does not describe a study where human readers (e.g., surgeons evaluating outcomes from images or reports) improved with AI assistance versus without. The Teno Fix™ is a physical surgical device, not an AI diagnostic tool, so an MRMC study in this context would be irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable/Not done. The Teno Fix™ is a physical medical device (tendon repair system) and does not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant to this submission.
7. The Type of Ground Truth Used
Based on the description of the studies:
- Canine Studies: Likely involved direct observation of healing, measurement of tendon gap reduction, and histological assessment of biocompatibility and implant stability. This would be considered outcomes data and potentially pathology.
- Human Clinical Study: Likely involved clinical assessment of patient outcomes, such as range of motion, pain levels, strength, complications, and potentially imaging to assess healing. This would be considered outcomes data and clinical assessment.
8. The Sample Size for the Training Set
Not applicable. As the Teno Fix™ is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device.
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