(268 days)
The MTF Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The MTF Pre-Sutured Tendon is for single patient use only.
The MTF Pre-Sutured Tendon is a construct consisting of a single tendon pre-sutured with UHWMPE non-absorbable surgical suture. The device may include a semitendinosus tendon. bilateral anterior and posterior tibialis tendon, or bilateral peroneus longus tendon., The Pre-Sutured Tendon passes USP sterility testing and is provided for a single patient use.
The provided text does not contain detailed information about acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to prove that the device meets those criteria with statistical rigor in the way one might expect for an AI/diagnosis device.
Instead, the document is a 510(k) summary for the MTF Pre-Sutured Tendon, a device that is compared to predicate devices to establish substantial equivalence. The "performance testing" section describes a comparison study and a cadaveric knee study to demonstrate equivalence or superiority to the predicate devices, rather than meeting pre-defined quantitative acceptance thresholds for accuracy, sensitivity, or specificity.
Here's an analysis based on the information provided, addressing your specific questions where possible. Many questions cannot be fully answered from this document because it's not a study report for an AI or diagnostic device with explicit acceptance criteria and performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance in qualitative terms of "equivalence to or better than" predicate devices rather than specific numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Visual characteristics comparable to predicate | Evaluated and found comparable. |
| Tensile strength equivalent to or better than predicate (K041553) | Equivalent to or better than. |
| Suture does not pull out or fail during pull testing | Suture does not pull out or fail. |
| Suture knot pull strength equivalent to or better than USP non-absorbable Surgical Sutures average knot pull strength | Equivalent to or better than. |
| Biomechanical performance (cadaveric knee study) equivalent to or better than surgeon-sutured quadruple bundled construct | No statistical difference either acutely or post-cycling. |
| Endotoxin level Tests. | |
| Sterility (USP ) | Passed USP sterility testing. |
| Ultimate load strength equivalent to predicate (K170957 & K041553) | Equivalent in ultimate load strength. |
2. Sample Size Used for the Test Set and Data Provenance:
- Tensile Strength/Pull Testing: Not specified.
- Cadaveric Knee Study: Not specified. The study involved "a cadaveric knee study," implying multiple cadaveric knees but no specific number is given. The provenance is implied to be cadaveric donations for research, but country of origin is not specified. It is a prospective study in the sense of comparing the novel device to a control construct in a controlled experimental setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Cadaveric Knee Study: The study involved orthopedic surgeons for implanting the construct. It compares the device to a "quadruple bundled construct sutured by a surgeon at the time of surgery." It does not explicitly state experts establishing "ground truth," but rather performing the control intervention and assessing implantability ("traditional clinical methods by an orthopedic surgeon"). No specific number or qualifications are provided beyond "orthopedic surgeon."
4. Adjudication Method for the Test Set:
Not applicable or not specified. This type of device does not involve subjective interpretations requiring adjudication for ground truth. The assessments are biomechanical and objective (tensile strength, pull out strength).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This device is not an AI or diagnostic tool that involves human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device (pre-sutured tendon), not an algorithm or AI.
7. Type of Ground Truth Used:
- Biomechanical Performance: Measured physical properties (tensile strength, suture pull-out strength, knot pull strength, ultimate load strength), and biomechanical outcomes in a cadaveric model.
- Biological Safety: Endotoxin levels and sterility testing.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the Study that Proves the Device Meets the (Implied) Acceptance Criteria:
The substantial equivalence of the MTF Pre-Sutured Tendon was demonstrated through a series of performance tests and a cadaveric knee study.
- Comparison Study: Visual characteristics and tensile strength of the pre-sutured tendon were evaluated and compared to the Arthrex Suture Grafting Kit (K041553). The suture's ability to resist pull-out and failure, along with its knot pull strength, were assessed against USP standards. The results indicated that the MTF Pre-Sutured Tendon was "equivalent to or better than" the predicate and USP standards.
- Cadaveric Knee Study: This study assessed the clinically relevant biomechanical performance of the construct when implanted with its intended fixation methods. It compared the MTF Pre-Sutured Tendon to a quadruple-bundled construct sutured by an orthopedic surgeon in an operating room setting. The study found "no statistical difference either acutely or post-cycling" between the two constructs. It also confirmed that the device could be implanted using traditional clinical methods.
- Biological Testing: The device's endotoxin levels were measured (less than 20 EU/device) and it passed USP and USP for sterility.
- Ultimate Load Strength: Comparison testing confirmed that the MTF Pre-Sutured Tendon is "equivalent in ultimate load strength" to its predicates (Allosource ReConnex K170957 and Arthrex Suture Grafting Kit K041553).
The overall conclusion was that the MTF Pre-Sutured Tendon is substantially equivalent to the predicate devices based on its materials, indications, function, and performance, with any differences not raising new questions of safety or effectiveness.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.