(41 days)
The ENDOTINE Chin ™ 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin ™ 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.
The ENDOTINE Chin™ 3.5 Device kit consists of the chin implant with insertion tool and a drill bit. The Chin device along with its insertion tool and drill bit are supplied sterile for single use only.
The provided text describes the ENDOTINE Chin™ 3.5 Device, a medical device intended for use in subperiosteal chinplasty surgery to fixate the subdermis to the mentum. The submission details a summary of the device's safety and effectiveness information in accordance with 21 CFR §807.92.
Acceptance Criteria and Study for ENDOTINE Chin™ 3.5 Device:
The documentation does not explicitly state numerical acceptance criteria in the format of precision, recall, or F1 score, or specific thresholds for strength. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices and meeting design specifications through performance studies.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similarity to predicate device (ENDOTINE Forehead Device) | Demonstrates substantial equivalence in design, materials, and fundamental scientific technology. |
| Design performance studies (cadaveric modeling and evaluation) | Performed and results exceeded specifications. |
| Strength testing results | Results exceeded specifications. |
| Material safety profile (for forehead and chin regions) | Established safety profile of the device material. |
| Suitability to perform and operate as clinically intended | Supported by an appropriate and complete testing program. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "cadaveric modeling and evaluation" as part of the design performance studies. However, the specific sample size (number of cadavers) and the country of origin of this data are not provided. It is implied to be a prospective study for device validation, as it's part of the pre-market submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "Feedback and user observation from several leading surgeons." This suggests expert input was gathered, but the exact number of surgeons, their specific qualifications (e.g., years of experience, subspecialty), and how their feedback established a formal "ground truth" are not detailed. It appears to be qualitative feedback rather than a structured ground truth establishment process for a test set in the context of AI/ML evaluation.
4. Adjudication Method for the Test Set:
Given the nature of the device (a physical fixation system) and the type of performance studies (cadaveric modeling, strength testing), the concept of an adjudication method typical for AI/ML evaluation (like 2+1, 3+1 consensus) does not apply and is not mentioned. Performance was likely evaluated directly against engineering specifications and clinical observations rather than expert consensus on interpretive tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm-only performance study was not done. The ENDOTINE Chin™ 3.5 Device is a physical implant, not an algorithm. Its performance is inherent to its design, materials, and mechanical properties when surgically implanted.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance appears to be established through:
- Engineering Specifications: Strength testing results exceeding pre-defined technical requirements.
- Clinical Observations/Feedback: User observation and feedback from surgeons, likely assessing functional performance and ease of use in a simulated or actual surgical context (implicitly, this would be expert opinion on the device's effectiveness and safety).
- Material Science Data: Established safety profile of the device material.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable as this is a physical medical device, not an AI/ML algorithm. Therefore, no sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's development was derived from design requirements, engineering principles, material properties, and feedback, rather than a labeled dataset for algorithm training.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.