(23 days)
The AUTOTAC System™ is intended to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the and normbloroonbable ituations 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 by either gamma or ETO sterilization and is not intended to be re-sterilized by the user.
Here's an analysis of the provided text regarding the AUTOTAC System™, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a medical device modification (K011675), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel device performance. As such, it does not contain all the typically requested information for a comprehensive study design demonstrating acceptance criteria.
Specifically, the document primarily addresses the mechanical performance and safety of the device through laboratory testing and clinical consultation, but it does not provide quantitative acceptance criteria or detailed study results in a format typically expected for demonstrating clinical effectiveness or accuracy in the way an AI/software device would.
However, I will extract and infer information where possible based on the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments / Context from Document |
|---|---|---|
| Sufficient pull-out strength to prevent premature movement of the periodontal membrane. | "Mechanical tests demonstrated that the pull-out... strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane." | The document states sufficiency but does not provide quantitative thresholds or measured values. This is an implicit functional acceptance criterion. |
| Sufficient shear strength to prevent premature movement of the periodontal membrane. | "...and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane." | Similar to pull-out strength, this is an implicit functional acceptance criterion without quantified values. |
| Effectiveness for fixation of barrier membranes without new health risks. | "evaluated by consulting clinicians and laboratory studies and found to be effective for fixation of barrier membranes without new health risks" | This is a qualitative statement of effectiveness based on expert opinion and laboratory studies. No specific metrics for "effectiveness" are provided. |
| Predictable means to achieve clinical success in guided bone and/or tissue regeneration. | "...and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration." | Another qualitative statement based on expert opinion and laboratory studies, without defined metrics for "predictable" or "clinical success." |
| Substantial equivalence to predicate device (K993493) regarding safety or effectiveness based on tack design, material, and intended use. | "substantially equivalent to all features which could affect safety or effectiveness to the predicate tack (K993493) due to the similarities in tack design, material and intended use." | This is the primary regulatory "acceptance criterion" for a 510(k) submission. The FDA concurred with this finding. |
Study Information (Based on available text)
Given the nature of this 510(k) for a physical device (a fixation tack), the study information requested is typically for software/AI devices or more complex clinical trials. The provided document details a regulatory submission for substantial equivalence of a physical medical device, not a performance study of an AI algorithm. Therefore, many of the requested fields are not applicable (N/A) or not detailed in this type of document.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "mechanical tests" and "laboratory studies" but does not give sample sizes for these tests.
- Data Provenance (country of origin, retrospective/prospective): Not specified. "Laboratory studies" generally imply controlled, prospective testing in a lab environment rather than clinical data from a specific country or population.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "consulting clinicians" (plural) were involved. The exact number is not stated.
- Qualifications of Experts: Not specified beyond being "clinicians." There is no mention of specialties or years of experience. For a physical device like this, these clinicians would likely be oral surgeons, periodontists, or related specialists.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/not specified. Clinical "adjudication" in the sense of resolving discrepancies in diagnostic reads (common for image analysis AI) is not relevant for the type of evaluation described here for a physical tack. The "consulting clinicians" likely provided a collective qualitative assessment.
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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 type of study was not done. This is a physical device, not an AI system.
- Effect size of human readers with/without AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the mechanical tests, the "ground truth" would be the measured physical properties (e.g., force required for pull-out/shear) against an implicitly accepted standard for "sufficiency." For the clinical evaluation, it appears to be a qualitative "expert consensus" from the "consulting clinicians" regarding effectiveness and predictability, likely based on their professional judgment and experience with membrane fixation.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a physical device, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set for this device.
§ 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.