Search Results

The CMI Implant IS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5 mm are indicated for molar regions.

The CMI Implant IS System is a dental implant system made of titanium Grade s of ASTM F 67 intended to be surgically placed in the bone of the upper or lower jaw arches. The CMI Implant IS System is composed of submerged fixtures with straight & angled abutments. To cover all case of surgery, each component of dental implant set has various size and dimension.

The provided text is a 510(k) summary for a dental implant system (CMI Implant IS System). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for a medical imaging or AI device. Instead, it relies on substantial equivalence to a previously cleared device.

Here's an analysis of the information that is present and a clear statement of what is missing based on your request:

Acceptance Criteria and Reported Device Performance

This section is not explicitly present in the document for the device being approved (K113554). The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K090825).

The only "performance" discussed for the subject device (K113554) is:

• Fatigue testing: Performed in accordance with ISO 14801 standard. The results are not specifically reported, only that the test was done.
• Risk analysis: Performed in accordance with ISO 14971 standard. Again, results are not reported.
• Biocompatibility and Sterilization: Stated as "Yes" and "Gamma Sterilization" respectively, matching the predicate device.

Since this 510(k) is for a physical medical device (dental implant) and not a diagnostic software or AI product, the concepts of "acceptance criteria" and "reported device performance" are geared towards mechanical and material properties, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for an AI study.

Missing Information: A table of specific acceptance criteria (e.g., minimum fatigue cycles, specific material strength thresholds) and the quantitative results for the CMI Implant IS System (K113554) that demonstrate it met these criteria. The document states that fatigue testing was done, but not what the acceptance criteria for fatigue were or what the device's actual performance was against those criteria.

Study Details (Relevant to AI/Diagnostic Devices - Not Applicable Here)

The provided document does not describe a study involving human readers, AI assistance, or ground truth establishment relevant to the type of device being approved (a dental implant). Thus, many of your requested points below are not applicable to this 510(k) submission.

1. Sample size used for the test set and the data provenance: Not applicable. This device is a physical implant, not a diagnostic system tested on data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of What This 510(k) Does Rely On:

The primary "study" or evidence for this 510(k) is the demonstration of substantial equivalence to an already cleared predicate device (CMI Implant IS System K090825). This means the manufacturer argued that their new device is as safe and effective as the predicate based on similarities in:

• Intended Use: Identical.
• Materials: Titanium Grade 4 of ASTM F 67 (same).
• Surface Treatment: RBM (same).
• General Shape, Structure, and Application Method Design: Stated as "same."
• Biocompatibility and Sterilization: Stated as "Yes" and "Gamma Sterilization" (same).

The modifications in K113554 compared to K090825 primarily involve:

• Addition of a "non-micro thread type" implant fixture.
• Addition of more sizes/models for various components.
• Change in shelf-life from 3 years to 5 years.

To support the substantial equivalence for these changes, the manufacturer submitted non-clinical test data related to:

• Fatigue testing (in accordance with ISO 14801 standard).
• Risk analysis (in accordance with ISO 14971 standard).

The approval letter confirms that the FDA reviewed this information and determined the device is substantially equivalent to the predicate.

Ask a specific question about this device

The Cowell Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is not intended for immediate loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

The Cowell Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text describes a 510(k) summary for the Cowell Implant System, a dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.

The document states:

• "The Cowell Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics."
• "The Cowell Implant systems are similar in fundamental scientific technology to the predicate devices (K090825, K053353) in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment."
• "concludes that the ball abutment is safe and effective and substantially equivalent to predicate devices as described herein."

This indicates that the device was approved based on its similarity to existing, approved devices and compliance with regulatory guidelines, rather than a standalone performance study with quantifiable acceptance criteria.

Ask a specific question about this device