(109 days)
The Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neo Implants - Neo Implant System are intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
Implant fixture: miplant is a threaded, internal abutment connection, root-form titanium dental implant. The Neo implant assortment consists of a number of implants with a diameter of mynant. The Neo miplangths between 7.0 -- 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equiped with interlocking elements for an insertion tool and the non-rotational locking of the abutitient. Supplied sterile.
Temporary part related to the fixture - Cover screw; Made in titanium for implantation. Supplied sterile.
Temporary part related to the fixture - Healing abutment; Made in titanium or PFEK for implantation. Supplied sterile.
Abutments: The Neo Abutment system is a set of modifiable gold alloy or commercially pure titanium abutments (Neolink), which are secured directly to the implant using an abutment screw. For easy wax-up a set of pre-shaped plastic copings can be used to fit to the abutment. Supplied non-sterile.
Prepable Ti abutments: Prepable titanium abutments of straight or angle (20 degrees or less) design made to be adjusted by clinician or dental technician. Crown or bridge cemented on prepped abutment. Supplied non-sterile.
Bar abutment; straight titanium or gold abutment cylinder to which a bar can be bonded (i.e welded or soldered) or cast on to. Supplied non-sterile.
Ball abutment; conventional design (ball head diameter 2,25 mm) used with standard attachments. Supplied non-sterile.
Abutment screw made in gold alloy or titanium. Screw driver connection compatible with screwdrivers supplied by Neoss. Supplied non-sterile.
Round bur; The round bur with diameter Ø1,8-2 with is ISO 1797-1 hand piece connection and shaft.
Twist drills: Two flute twist drill with ISO 1797-1 hand piece connection and shaft. Depth marking corresponding to the implant lengths in the Neoss implant system, hence 7, 9, 11, 13, 15 and 17. Diameter from Ø2.2 to Ø5,1 in appropriate steps to match the Neoss implants.
Screwtap: Screwtap for the different implant diameters existing in the Neo Implant system (Ø3,5 to Ø5,5) with ISO 1797-1 hand piece connection and shaft.
Countersink: Countersink, (05,5) with ISO 1797-1 hand piece connection and shaft. The tool has a centring tap in relation to the prepared hole.
Material of bone cutting instruments is medical grade stainless steel currently being used for similar components.
The provided text describes the Neoss Ltd Neo Implant System and its submission for 510(k) premarket notification. It asserts substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.
Instead, the submission relies on the concept of substantial equivalence to existing legally marketed devices. This means that the manufacturer argues their new device is as safe and effective as a predicate device already on the market, rather than conducting a new, comprehensive clinical study to prove performance against pre-defined acceptance criteria.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC study, standalone performance) cannot be answered from the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here implicitly refer to the demonstration of substantial equivalence to predicate devices.
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Reported Device Performance: Not reported in terms of clinical outcomes or specific quantitative metrics against acceptance criteria. The performance is implied to be equivalent to the predicate devices.
The document mentions:- Mechanical Testing: "Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996."
- Conclusion regarding further testing: "Neo implant and abutment designs are within the scope of the Guideline... why we have come to the conclusion that further testing will not race new issues of safety and efficacy." and "Neo bone cutting instruments, are in terms of design, material, dimensions, and intended us in all relevant aspect identical to predicative devices why we have come to the aonclusion that further testing will not race new issues of safety and efficacy."
This indicates that the manufacturer believes their device meets the expectations of the guideline and is sufficiently similar to predicates that further testing for safety and efficacy to establish new acceptance criteria is not needed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. No clinical test set or data provenance is detailed, as the submission relies on substantial equivalence rather than a new clinical study with a test set.
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)
- Not applicable/Not provided. No test set requiring expert-established ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set requiring adjudication 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
- No MRMC study was done, as this is a dental implant system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (dental implant), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No new ground truth was established for a performance study. The "ground truth" for the submission is the established safety and efficacy of the predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. This is a medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a medical device, not a machine learning model.
In summary: The provided document is a 510(k) summary for a dental implant system. The regulatory pathway of "substantial equivalence" as utilized here means that the manufacturer is demonstrating that their device is as safe and effective as pre-existing, legally marketed predicate devices, rather than conducting new clinical trials to meet specific, quantified acceptance criteria. Therefore, most of the questions pertaining to clinical study design, data sets, expert review, and ground truth are not addressed in this type of submission.
§ 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.