Search Results

Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the MIS Crest Widener, addressing your requested information:

Summary of Acceptance Criteria and Device Performance (based on the provided document):

The provided 510(k) summary for the MIS Crest Widener does not contain specific quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., success rates, bone growth measurement).

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" being evaluated and asserted is primarily in terms of:

• Intended Use: The device shares the same intended use as its predicate devices: "Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation."
• Technological Characteristics: The device is made of similar materials (Titanium alloy complying with ASTM F136-02), has a similar mechanism of action (distraction osteogenesis via screw activation), and a similar duration of placement.

Therefore, the "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device performs as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness.

Key Missing Information:

It's crucial to note that the provided 510(k) summary does not include any clinical study data or performance metrics that would typically be found in a study proving a device meets specific acceptance criteria. This type of submission relies on the established safety and effectiveness of the predicate devices.

Given this, I cannot fill in precise quantitative values for acceptance criteria or device performance as they are not present in the document.

Detailed Breakdown of Your Requested Information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. The document does not describe a clinical study with a "test set" of patients or data to evaluate the device's performance. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo clinical performance data.
• Data Provenance: Not applicable, as no dedicated test set data is presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. As there is no clinical test set described, there is no mention of experts establishing ground truth for such a set. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices, as deemed by prior FDA clearances.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set or data analysis requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a manual surgical instrument and does not involve any algorithms or standalone software performance.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the documented performance, safety profile, and regulatory history of the legally marketed predicate devices. The new device asserts equivalence to these established devices. This is not "expert consensus," "pathology," or "outcomes data" specifically generated for the MIS Crest Widener, but rather the established understanding of the predicates.

8. The Sample Size for the Training Set

• Not applicable. This device is a manual surgical instrument and does not involve machine learning algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device