(148 days)
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The proposed pre-sterilized, single-use, disposable drills, taps and burs (3i UniSystem) will be of the same design as previous products but will be constructed of "High Speed Surgical Steel" per AISI M2. All 3i drills are marked at the appropriate depth lengths to assist the clinician in proper drilling and are labeled with the correct drill diameter(s). Each drill is also identified as a "3i" device.
This document is a 510(k) summary for a medical device (pre-sterilized, single-use, disposable drills, taps, and burs) and does not contain the kind of study information requested. The document describes the device, its intended use, packaging, sterilization methods, contraindications, warnings, precautions, adverse effects, and substantial equivalence to previously cleared devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as that information is not present in the provided text.
Here is an explanation for each point, indicating why the information is not present:
- A table of acceptance criteria and the reported device performance: This document does not define specific performance acceptance criteria for the drills, taps, and burs. It discusses features like "sharper cutting edge" and "improved drilling efficiency with less trauma to remaining bone" as benefits, but these are not quantified or presented as acceptance criteria.
- Sample size used for the test set and the data provenance: No performance testing data or a "test set" is mentioned. The device is being cleared based on substantial equivalence to existing devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there is no "test set" or performance data, this information is not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or performance study is described.
- 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: This device is a surgical tool, not an AI diagnostic or assistive device. Therefore, an MRMC study is not relevant, and no such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical tool, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance study is described. The "ground truth" for this device's efficacy relies on its design, material, and proven sterilization methods, and its substantial equivalence to other legally marketed devices.
- The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no "training set" is used.
- How the ground truth for the training set was established: Not applicable for the same reasons as above.
The document focuses on demonstrating that the new disposable, pre-sterilized drills are substantially equivalent to existing, legally marketed drills, primarily by detailing the material change (from stainless steel to "High Speed Surgical Steel" per AISI M2) and the addition of pre-sterilization. The only "performance" discussed is the sterility assurance level (SAL).
Specifically, regarding sterility, the document states:
- Acceptance Criteria (Implied): A Sterility Assurance Level (SAL) of ten to the minus six (10^-6).
- Reported Device Performance (Implied): Achieved by using Co60 Irradiation at a minimum dose of 25.0 kGy (2.5 mRads).
- Study Proving Acceptance: "Validation of sterilization process shall be accomplished as specified by the Association for the Advancement of Medical Instrumentation. Irradiation sterilization shall be accomplished by an FDA registered irradiation sterilization facility." This indicates that the sterilization process itself is validated according to established standards, rather than a performance study on the device's cutting ability. This validation procedure is the study that proves the device meets the sterility acceptance criteria, although specific raw data or sample sizes from this validation are not included in this summary.
§ 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.