(56 days)
The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative performance metrics are mentioned in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding a "test set" or a study designed to evaluate the performance of the Erich Arch Bar. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no test set or ground truth establishment process is described for this specific device.
4. Adjudication Method for the Test Set
Not applicable, as no test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned. This 510(k) submission does not present data on human reader improvement with or without AI assistance, as it pertains to a physical medical device (arch bar) and not an AI/software device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable, as this is a physical medical device and not an algorithm or software.
7. The Type of Ground Truth Used
Not applicable, as the submission does not involve the establishment of ground truth for performance evaluation; it focuses on substantial equivalence to existing devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device is not an AI/machine learning model.
Summary of the K061271 Submission and Lack of Performance Data:
The provided 510(k) summary for the KLS-Martin Erich Arch Bar describes a submission focused on demonstrating substantial equivalence to predicate devices. This type of regulatory submission primarily relies on showing that the new device has "identical in application and indications for use" and similar "material composition and application" to devices already legally marketed.
Therefore, the document does not include:
- Specific acceptance criteria for performance.
- Results from a formal study (test set, training set).
- Details about expert ground truth, adjudication, or MRMC studies.
The FDA's letter (pages 2-4) confirms that they reviewed the submission and determined substantial equivalence, allowing the device to be marketed based on this comparison, rather than requiring new clinical performance data demonstrating its efficacy or safety against pre-defined performance criteria.
§ 872.4600 Intraoral ligature and wire lock.
(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(b)
Classification. Class II.