(258 days)
The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.
Pin with a flat head for the fixation of resorbable and non-resorbable membranes.
This is a 510(k) summary for a medical device (MP Pin without thread, flat head) which is seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy in the way a pharmaceutical might.
Therefore, the requested information, which is typically associated with clinical trials, statistical performance metrics, and AI/software device studies, is largely not applicable or present in this document.
Here's an breakdown based on the provided text, addressing why some information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would undergo. Instead, substantial equivalence is based on:
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (from document) |
|---|---|
| Intended Use/Indications for Use: Identical to predicate device | The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes. (Identical to predicate) |
| Material: Same as predicate device | Composed of the same titanium alloy (3.7165 6Al-4V ELI) as the predicate device. |
| Principle of Operation: Identical to predicate device | Identical principles of operation (i.e., the fixation of resorbable and non-resorbable membranes). |
| Safety - Biocompatibility: No cytotoxicity observed | Cytotoxicity testing per ISO 10993-5 showed results confirming biological safety. |
| Safety - Sterilization: Validated as per standard | Sterilization validation performed per ISO 17664 and ISO 17665-1. |
| Safety - New Risks: No new risks identified compared to predicate | Differences in dimensions due to pin head geometry (flat head vs. hexagonal) do not raise new risks with regard to safety or performance, as determined by internal validation based on IEC 62366-1. |
2. Sample size used for the test set and the data provenance
This information is not applicable as this submission is for a mechanical medical device (a pin) and does not involve AI or software that would typically have a "test set" of patient data. The "performance data" refers to standard mechanical and biological testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable for the reasons stated above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable as this device is a physical medical pin and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this device is a physical medical pin and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility testing, the "ground truth" would be the standard biological response according to ISO 10993-5, where the absence of cytotoxicity is the desired outcome. For sterilization, the "ground truth" is compliance with the specified ISO standards for sterility. For mechanical and dimensional evaluation, the "ground truth" relates to engineering specifications and comparison to the predicate device's design, assessed through internal validation.
8. The sample size for the training set
This information is not applicable as this submission is for a mechanical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
In summary: The provided document is a 510(k) summary for a physical medical device. The "study" proving it meets acceptance criteria consists of standard engineering, biocompatibility, and sterilization testing, not clinical trials or AI performance evaluations as would be implied by many of the questions. The acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, fundamental operation, and safety.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.