(242 days)
The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.
The Intra-Lock Hydroxyapatite Coated Implants consists of root form dental implants that are manufactured from CP Ti and have a Hydroxyapatite coating. These implant designs are either threaded or smooth cylindrical shapes and are substantially equivalent to devices previously marketed. They have the same indications and applications for surgical restoration of partially or fully edentulous patients as pre-amendment devices.
The provided text is a 510(k) summary for a medical device, the Intra-Lock Hydroxyapatite Coated Implants. It details the device's characteristics, indications for use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The submission is a "Special 510(k): Abbreviated 510(k)" which relies on conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This type of submission generally means that the device is substantially equivalent to existing devices and adheres to established performance standards or recognized consensus standards, rather than presenting a novel study with specific acceptance criteria and performance data for a new technology or algorithm.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study is not described.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not list specific acceptance criteria or performance metrics for the Intra-Lock Hydroxyapatite Coated Implants. It relies on substantial equivalence to predicate devices and conformity to a guidance document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No ground truth establishment or expert involvement in a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method for a test set is mentioned.
5. 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
- Cannot be provided. This device is a dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth for device performance is mentioned as there is no study described. The "ground truth" for regulatory approval here is the demonstrated substantial equivalence to legally marketed predicate devices and adherence to relevant guidance.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. There is no mention of a training set for an algorithm.
Summary of available information:
- Device Name: Intra-Lock Hydroxyapatite Coated Implants
- Sponsor: Intra-Lock International
- Predicate Devices: Ace HA Screw Implant System (K021244), HA-TI Implant (K003045), BMR Dental Implant System (K010343), Replace Ha Coated Implants (K962845), Sterngold HA Coated Screws (K981516), Restore HA Coated Implants (K960288).
- Product Description: Root form dental implants manufactured from CP Ti with a Hydroxyapatite coating. They are threaded or smooth cylindrical shapes.
- Indications for Use: To restore partially or fully edentulous patients, suitable for mandible or maxilla, and to support removable or fixed prosthesis (single tooth to full arch reconstruction).
- Basis for Approval: Special 510(k): Abbreviated 510(k) demonstrating conformity with FDA's "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA" and substantial equivalence to predicate devices.
The document focuses on regulatory compliance through substantial equivalence to existing devices and adherence to guidance, rather than presenting a performance study with specific acceptance criteria that would typically be associated with a novel device or software.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.