(147 days)
The Allograft Anchor is intended for use in soft tissue approximation and/or ligation in orthopaedic procedures.
The anchor, suture, needles and inserter are all packaged together. The kit contains one allograft anchor, loaded with one strand of #2 braided polyester suture, green, and one strand of #2 braided polyester suture, white. To each end of suture is attached a CP-2 needle. The anchor, suture and needles are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture and the needles reside in the card placed within the inserter handle.
The inserter, with the enclosed anchor, et al., delivers the product to the site. The inserter is composed of a plastic body (with an anchor release mechanism) and a stainless steel tube with a stainless steel shaft for anchor deployment. A drill or punch is provided to create a hole to deliver the anchor. The inserter, contents are housed within a plastic tray. All components are single use only and sterile.
Here's an analysis of the provided text regarding the MTF Allograft Anchor, focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Input Requirements) | Reported Device Performance |
|---|---|
| Strength (Anchor Insertion & Fixation) | Met design input requirements for strength. |
| Dimensions | Within design requirements. |
| Insertion Repeatability | Found to be acceptable. |
| Pullout Values for Fixation Strength | Exceeded those of metal and polymeric devices used for similar types of fixation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the biomechanical testing (test set). The data provenance is also not specified; it is assumed to be internal testing conducted by the manufacturer, Musculoskeletal Transplant Foundation (MTF).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The study described is biomechanical testing, not a clinical study involving experts establishing ground truth from patient data.
4. Adjudication Method
Not applicable. The study is a biomechanical test, not a clinical study requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text describes a biomechanical study, not a clinical study involving human readers or comparative effectiveness with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a physical medical device (an anchor), not an algorithm or AI-driven system. The "standalone" performance here refers to the device's inherent mechanical properties.
7. Type of Ground Truth Used
The ground truth for this device's performance is based on engineering and biomechanical measurements against predefined design input requirements. This includes metrics like strength, dimensions, insertion repeatability, and pullout force.
8. Sample Size for the Training Set
Not applicable. This is a biomechanical test of a physical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device in this context. The "ground truth" for the device's performance was established by the design input requirements of the manufacturer and validated through the described biomechanical tests.
§ 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.