(105 days)
The Allofix™ Anchor is indicated for use in the attachment of soft tissue to bone in orthopedic procedures.
The Allofix™ Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.
The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with two strands of #2 polyethylene suture, blue, and one strand of white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle. The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube with two #2 sutures. 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 and sterile.
Here's an analysis of the provided text regarding the Allofix™ Anchor, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only briefly mentions "design input requirements for strength" and "design requirements" for dimensions. It does not provide specific quantitative acceptance criteria. Therefore, the table below reflects the qualitative statements made.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Design input requirements for strength | The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Anchor meets design input requirements for strength. Pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation. |
| Design requirements for dimensions | The tests also confirmed that the Allofix™ Anchor dimensions were within design requirements. |
| Insertion repeatability | Insertion repeatability was found to be acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Biomechanical testing of the Allofix™ Anchor was performed". It does not specify the sample size used for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's implied to be in vitro biomechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The "ground truth" for the biomechanical tests would likely be established by the testing methodology itself (e.g., universal testing machine readings for strength, precise measurement tools for dimensions), rather than expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Biomechanical testing generally relies on objective measurements rather than expert adjudication.
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
An MRMC comparative effectiveness study was not done. This device is a medical implant (bone anchor), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Allofix™ Anchor is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "strength" and "dimensions" tests would be based on objective physical measurements obtained through biomechanical testing equipment and metrology, compared against the pre-defined design specifications. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This is not applicable as the Allofix™ Anchor is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the Allofix™ Anchor is not an AI/ML device.
§ 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.