(46 days)
The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) summary for the Stryker ENT LATERA Absorbable Nasal Implant System. A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here refer to the design specifications and performance standards met to demonstrate equivalence, and the "study" is the performance testing conducted for that purpose. There is no AI/ML component to this device or its evaluation presented in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Device Performance (Based on "Performance Data" in the 510(k) Summary) |
|---|---|
| Design Specifications | All design verification testing passed, indicating the device meets its design specifications. This includes testing related to the modified implant geometry and the additional implant size (20mm). Specific quantitative criteria for design elements (e.g., tensile strength, degradation rate) are not detailed in this summary but are implicit in "design specifications." |
| Shelf Life | Shelf life testing was completed and passed, supporting an extended shelf life. (Specific duration not provided in summary). |
| Sterilization | Sterilization testing was completed and passed, supporting the modified sterilization process. (Specific sterility assurance level not provided in summary). |
| Biocompatibility | Stated to have the same biocompatibility as the predicate device, implying it meets established standards (though no specific tests or results are detailed in the summary). |
| Functionality | Performed as intended. (Specific functional criteria like optimal support force, consistent deployment, etc., are not detailed but are implied by "performed as intended"). |
| Safety and Effectiveness | Demonstrated to be "as safe and as effective as the predicate device" and "substantially equivalent." This is the overarching "acceptance criteria" for a 510(k). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for individual tests (e.g., number of implants tested for tensile strength, number of sterilization cycles validated). The testing is generally referred to as "design verification testing and distribution testing to support the additional implant size."
- Test Set Size: Not specified.
- Data Provenance: Not specified, but generally, such testing is conducted internally by the manufacturer or by contract labs in the country of origin of the manufacturer (USA, given the address). The testing is prospective in nature, as it is performed to validate the device's design and manufacturing processes prior to marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a physical implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) summary. Performance is evaluated through engineering and biocompatibility testing against predefined specifications.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, this is basic engineering and biocompatibility testing, not a clinical trial or AI evaluation requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is a physical medical device (nasal implant), not an imaging or diagnostic AI tool. An MRMC study is not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. There is no algorithm or AI component involved in its function or evaluation as described in this document.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Pre-defined design parameters, material properties, and functional requirements.
- Established Test Standards: Adherence to recognized biocompatibility standards, sterilization validation methods, and shelf-life determination protocols.
- Predicate Device Characteristics: The LATERA Absorbable Nasal Implant [K161191] serves as the benchmark for demonstrating "substantial equivalence" in terms of safety and effectiveness, meaning features and performance are shown to be equivalent to an already cleared device.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI/ML component; therefore, no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.