(70 days)
The LEADfix Bioresorbable Membrane Pin System is intended to be used to fixate and stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity. The LEADfix membrane pin is similar in intended use to other marketed membrane screws, including the IMZ Membrane Tack System and the Memfix screws, which are intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity.
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The LEADfix Bioresorbable Membrane Pin System consists of components and instruments designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The system provides an anchoring mechanism for the membranes to resident and adjacent bone at the surgical site. The LEADfix membrane pin is fabricated from a bioresorbable polymer. The pin has a low profile, round, lens shaped head and a shaft with two circular ribs. The system also consists of stainless steel instrumentation designed to place the pin at the surgical site.
The provided 510(k) summary for the LEADfix® Bioresorbable Membrane Pin System describes a medical device, not a software-driven AI device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI performance metrics (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), is not applicable to this document.
The document discusses the substantial equivalence of the LEADfix system to predicate devices based on its intended use, design, materials, and non-clinical/clinical conclusions.
Here's an analysis of the provided text in the context of device approval, though not for AI:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner as one would expect for AI performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is described qualitatively:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sufficient strength to fix an absorbable membrane material to bone. (Nonclinical) | "Pull force testing of the LEADfix Bioresorbable Membrane Pin demonstrate that the pin has sufficient strength to fix an absorbable membrane material to bone. Results showed that the absorbable membrane material does not possess the strength to pull the implanted LEADfix pin out of bone without compromising itself in the process." |
| Effectively assists clinicians to fixate membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration. (Clinical) | "Clinical use of the LEADfix pin in conjunction with absorbable barrier membranes demonstrate that the LEADfix pin effectively assists clinicians to fixate membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration." |
| Safety and effectiveness comparable to predicate devices. | "Both in vitro and in vivo examination and use of this material do not raise new questions of safety or effectiveness as compared to predicate devices." |
| "The device does not raise new issues or questions of safety and effectiveness as compared to predicate devices." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document mentions "Pull force testing" (nonclinical) and "Clinical use" (clinical) but does not provide numbers for participants or specimens.
- Data Provenance: Not specified. Given the applicant is from Germany, it's possible some data originated there, but no details are provided. The studies appear to be proprietary tests conducted by the manufacturer, rather than large-scale population data.
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.
- Qualifications of Experts: Not specified. Clinical use would implicitly involve dental professionals, but no details are given.
4. Adjudication method
- Adjudication Method: Not applicable/Not specified. The assessment appears to be based on direct measurement (pull force) and clinical observation/outcomes, rather than expert adjudication of a diagnostic output.
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: No, this is not an AI device. This type of study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this is not an AI device. The device is a physical pin system, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth:
- For non-clinical performance (pull force), the ground truth would be quantitative measurements of various mechanical properties (e.g., force required to pull out, material integrity).
- For clinical performance, the ground truth would be observed clinical outcomes, such as successful membrane fixation, predictable bone/tissue regeneration, and absence of new health risks.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI device that requires training data in the machine learning sense. The device's design and material properties are based on scientific principles and engineering, not iterative training on a dataset.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
In conclusion, the provided document is a 510(k) summary for a physical medical device, not an AI software. As such, the specific criteria and study details requested, particularly those related to AI algorithm performance evaluation, are not present or relevant in this context. The document focuses on demonstrating substantial equivalence through non-clinical testing and clinical observation.
§ 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.