(84 days)
The AUTOTAC System™ is intended to fixate and stablize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use/fixation.
The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.
The AUTOTAC System™ consists of components and instruments designed to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation. The system provides an anchoring mechanism for the membranes to resident and adjacent bone or tissue at the surgical site. The Tissue Tack is fabricated from a well-known bioresorbable polymer and has a round, flat head, and two circular ribs on the shaft to prevent the implanted tack from slipping out. The tack is provided sterile and is not intended to be resterilized by the user.
The provided text describes a 510(k) premarket notification for "The AUTOTAC System™," a medical device intended to fixate and stabilize barrier membranes in tissue regeneration. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically found in clinical efficacy trials for novel devices.
Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not available in the provided document. The 510(k) pathway primarily relies on demonstrating equivalence in terms of intended use, technological characteristics, and safety/effectiveness, often through non-clinical testing and comparison to legally marketed predicate devices.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: Effective for fixation of barrier membranes without new health risks and a predictable means to achieve clinical success in guided bone and/or tissue regeneration. | Evaluated by consulting clinicians in animal tests and laboratory studies and found to be effective for fixation of barrier membranes without new health risks and is a predictable means to achieve clinical success. |
| Mechanical Strength (Pull-Out): Pull-out strength equivalent to predicate devices. | Mechanical tests demonstrated that the pull-out strength of the AUTOTAC System™ was equivalent to the predicate devices. |
| Material Compatibility (Shear Loading): The resorbable membrane will not deleteriously affect the implanted tack under shear loading. | In-vitro mechanical tests demonstrated that the resorbable membrane will not deleteriously affect the implanted tack under shear loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for animal tests, laboratory studies, or mechanical tests. The document refers to "animal tests and laboratory studies" and "in-vitro mechanical tests" broadly.
- Data Provenance: The studies mentioned are "animal tests" and "laboratory studies," implying pre-clinical data. The country of origin is not specified, but the submission is to the US FDA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Consulting clinicians" were involved in evaluating the system in animal and laboratory tests. The specific number is not provided.
- Qualifications: "Consulting clinicians" are mentioned. No further details on their specific qualifications (e.g., area of specialization, years of experience) are provided.
4. Adjudication Method for the Test Set
- No information on adjudication methods is provided. The evaluation by "consulting clinicians" is mentioned, implying expert assessment, but the process of reaching consensus or resolving discrepancies is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. This type of study is more common for diagnostic imaging AI systems to evaluate physician performance with and without AI assistance, which is not relevant to this device (a physical implant/fixation system).
6. Standalone (Algorithm Only) Performance Study
- No, a "standalone" performance study (in the context of an algorithm's performance without human intervention, as typically seen with AI/software as a medical device) was not conducted. The AUTOTAC System is a physical medical device. The "standalone" concept doesn't apply to the same degree as it would for a diagnostic algorithm. The device's performance is inherently tied to its use by a clinician.
7. Type of Ground Truth Used
- For the functional effectiveness, the "ground truth" seems to have been established through expert clinical observation and assessment in animal models and laboratory settings, determining "effectiveness for fixation of barrier membranes without new health risks" and leading to "clinical success."
- For mechanical tests, the "ground truth" for equivalence in pull-out strength and resistance to shear loading would be quantitative measurements of these physical properties compared to predicate devices, presumably against engineering specifications or established performance benchmarks.
8. Sample Size for the Training Set
- This concept is not applicable here. The AUTOTAC System is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its iterative design, development, and testing processes.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the concept of a "training set" doesn't apply to this physical device. Therefore, no information on how its ground truth was established is relevant or provided.
§ 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.