(109 days)
The Zone Specific AIM™ Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including repair of meniscal tears.
The Zone Specific AIM™ is an all-inside meniscal repair device that sequentially deploys implants and suture. The device is composed of peek implants and ultra-high molecular weight polyethylene (UHMWPE) suture (Hi-Fi). The handheld, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The anchor, suture, and disposable handheld device are EO Sterilized.
This is a 510(k) premarket notification for the Zone Specific AIM™ Device, a meniscal repair device. The document primarily focuses on establishing substantial equivalence to a predicate device (ConMed Linvatec Sequent™ Meniscal Repair Device).
Since this is a 510(k) submission for a medical device that performs a mechanical repair, the acceptance criteria and performance data are primarily focused on physical and mechanical properties, not on a diagnostic algorithm. There is no AI component described in this document. Therefore, many of the requested fields related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract the general acceptance criteria and the types of studies performed to demonstrate the device's performance relative to its intended use and substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison for each test. Instead, it states that "Testing has been completed to demonstrate that the Zone Specific AIM™ performs as intended and is substantially equivalent to the predicate device" and "met the endotoxin limits." This implies that the device met the acceptance criteria for each test, but the specific numerical targets and results are not detailed in this summary.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Performance | Performs as intended and is substantially equivalent to the predicate device in terms of: |
| Ultimate Fixation Strength | Successfully demonstrated (implied to meet predicate performance/safety standards) |
| Cyclic Performance | Successfully demonstrated (implied to meet predicate performance/safety standards) |
| Material/Biological Safety | Performed as intended and is substantially equivalent to the predicate device in terms of: |
| Pyrogenicity (Bacterial Endotoxin) | Met the endotoxin limits |
| Biocompatibility | Successfully demonstrated (implied to meet safety standards) |
| MR Safety | Successfully demonstrated (implied to be safe for MR environments) |
| Device Integrity/Reliability | Performed as intended and is substantially equivalent to the predicate device in terms of: |
| Reliability | Successfully demonstrated |
| Transportation | Successfully demonstrated |
| Packaging | Successfully demonstrated |
| Labeling | Successfully demonstrated |
| Sterilization | Successfully demonstrated |
| Shelf-life | Successfully demonstrated |
| Usability | Performs as intended: |
| User Validation | Successfully demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for mechanical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a mechanical device, not an AI diagnostic algorithm. "Ground truth" in this context would refer to established engineering standards or validated test methods, not expert consensus on anatomical findings.
4. Adjudication Method for the Test Set
Not applicable. This is a mechanical device. Adjudication methods like 2+1, 3+1 are used for human review of data, typically in diagnostic studies.
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
Not applicable. This document does not describe an AI-powered device or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an AI algorithm.
7. The Type of Ground Truth Used
For mechanical and material tests, the "ground truth" implicitly refers to:
- Established engineering standards (e.g., ASTM, ISO standards for strength, cyclic loading, sterilization effectiveness, biocompatibility).
- Predicate device performance data, used as a benchmark for substantial equivalence.
- Regulatory limits (e.g., for endotoxin levels).
8. The Sample Size for the Training Set
Not applicable. There is no AI training set described.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI training set described.
§ 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.