(98 days)
Featherlift Aptos Extended Length Threads are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
The threads are a blue, nonabsorbable, sterile, surgical strand of polypropylene. The product is USP size 2-0 polypropylene suture material 25 centimeters in length and incorporates a unidirectional-cogged section 10 centimeters long from the distal end. A 2 ¾ straight taper cutting needle made of 400 series stainless steel will be swedged to the proximal end. An introducer made of 18 gauge stainless steel will be included for placement of the Threads. The threads and the introducer are supplied sterile for single use.
The provided text is a 510(k) summary for a medical device called "Featherlift™ Extended Length Aptos Threads". This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
Preamble:
It's important to note that this 510(k) submission focuses on demonstrating substantial equivalence to an existing predicate device (Coapt Endotine Midface ST 4.5 device K032698), not on meeting specific, quantitative performance criteria derived from a primary clinical study with defined acceptance thresholds as one might see for a novel device or software. The "performance data" mentioned refers to bench and animal testing comparing the new device to standards, not human clinical trials with specific statistical endpoints to prove new clinical efficacy beyond what is already accepted for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, there isn't a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the document highlights how the Featherlift™ Threads are equivalent to the predicate device in terms of intended use, indications for use, and safety, while also pointing out some advantages.
The "performance data" section states:
- "Physical testing was conducted on the thread to USP 27 for tensile strength, force required to remove after implantation and Biocompatability for permanent implantation, ISO 10993."
- These are bench and animal evaluations, not human clinical performance data against specific acceptance criteria for clinical outcomes. The document does not provide the specific quantitative results of these tests or explicit "acceptance criteria" for them beyond adhering to USP and ISO standards.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable. The document describes bench and animal testing (physical testing, biocompatibility), not a clinical "test set" from human data. The provenance of the animal data is not specified (e.g., country of origin).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. There was no human clinical "test set" and thus no ground truthing by human experts for clinical outcomes. The testing was physical and biocompatibility testing.
4. Adjudication Method for the Test Set
This is not applicable, as there was no human clinical "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This device is a polypropylene suture for midface suspension, not an imaging or diagnostic device that would typically involve an MRMC study with human readers.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. This is a physical medical device (suture), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the performance data referenced relates to:
- USP 27 standards for tensile strength and force required to remove after implantation.
- ISO 10993 standards for biocompatibility for permanent implantation.
- For the core substantial equivalence argument, the "ground truth" is established by showing similarity in intended use, indications for use, and technological characteristics to the predicate device (Coapt Endotine Midface ST 4.5 device K032698), which has already been deemed safe and effective.
8. Sample Size for the Training Set
This is not applicable, as there is no "training set" in the context of this physical device's 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set."
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.