(51 days)
The ENDOTINE MidfaceTM-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution tools are supplied sterile for single use only.
The provided text describes a 510(k) summary for the ENDOTINE Midface™-ST 4.5 Device, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving device performance against those criteria.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a tabular format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Similarity to predicate devices in design, materials, and function | The device is substantially equivalent to predicate devices (ENDOTINE Forehead, PDS II Suture, Lactosorb Panels) in design, materials, and fundamental scientific technology. |
| Compliance with user specifications and USP Standards for absorbable surgical sutures | Performance data meet applicable standards and fulfill device requirements as defined in user specifications and USP Standards for absorbable surgical sutures. |
| Safety and appropriateness for intended use | Safe and appropriate for intended use due to similarity to predicate devices, extensive cadaver modeling/evaluations, and positive user feedback. No new issues of safety or effectiveness raised. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not mentioned. The document refers to "extensive cadaver modeling and evaluations" but does not specify a sample size for these evaluations related to performance testing.
- Data provenance: Not explicitly stated as a test set. The "cadaver modeling and evaluations" would typically be prospective laboratory/pre-clinical data. The "user observation from several leading surgeons" is feedback, not a structured test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified. The document mentions "several leading surgeons" provided feedback and user observation, but it doesn't describe their role in establishing a ground truth for a test set.
- Qualifications of experts: Described as "leading surgeons," but no specific details on their experience (e.g., years of experience, specialization) are provided.
4. Adjudication method for the test set
- Adjudication method: Not mentioned. No dedicated "test set" with ground truth established through adjudication is described.
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
- MRMC study: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Ground truth: Not explicitly defined in the context of a "test set" for performance evaluation against a specific clinical outcome. The nearest equivalents are:
- Predicate devices: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.
- USP Standards: Compliance with established industry standards for absorbable sutures.
- User specifications: Device requirements as defined by user needs.
8. The sample size for the training set
- Sample size for training set: Not applicable based on the information provided. The document describes pre-clinical evaluations (cadaver modeling) and feedback, not a formalized "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable. As there's no mention of a training set, the establishment of its ground truth isn't discussed.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.