(186 days)
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
• replacing maxillary lateral incisors and mandibular incisors,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.
The Piccolo Implants and Accessories is a threaded root-form dental implant and abutment system.
The implants are Ø3.0 mm in diameter with lengths of 8.5, 10, 11.5, 13 and 15 mm. There is a standard version and a MSC version with a 1 and 3 mm machined surface coronal region respectively. The rest of the body has a roughened surface. The system has an external hexagonal implant-abutment interface.
The following abutments are included in the range: Cover Screws, Healing Abutments (all made from commercially pure titanium (CPTi)), Gold Abutments (made from gold alloy), Passive Abutments and Compact Conical Abutments (both made from titanium alloy). All abutments (except the onepiece abutments) are used with a titanium alloy retaining screw.
The provided text is a 510(k) summary for a medical device (Piccolo Implants and Accessories) and details its substantial equivalence to predicate devices. It does not describe an acceptance criteria and study as typically conducted for performance claims of AI/ML or diagnostic devices. Instead, it focuses on non-clinical performance and material equivalence.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on demonstrating substantial equivalence through engineering analysis, dimensional analysis, dynamic compression-bending tests, and material/sterilization/packaging equivalence to predicates, rather than a clinical performance study with human readers, AI assistance, or expert ground truth.
However, I can extract the information that is present concerning performance data and equivalence.
Acceptance Criteria and Device Performance (Based on Non-Clinical Data)
| Acceptance Criteria Category | Reported Device Performance / Method of Proof |
|---|---|
| Material Equivalence | The device is manufactured from the same material (CPTi - cold worked for implants, CPTi, Titanium alloy, Gold alloy for abutments) using the same manufacturing method as predicate devices (K163060, K163634). Biocompatibility is also established in accordance with ISO 10993-1 and ISO 10993-5 (Cytotoxicity testing) for the same materials. |
| Dimensional & Design Equivalence | The implants are Ø3.0 mm in diameter with lengths 8.5, 10, 11.5, 13, and 15 mm, with an external hexagonal implant-abutment interface, and have both standard and MSC versions with varying machined surface coronal regions. This was compared to the primary predicate (K163060) which also has Ø3.0 implants, and a reference device (K163634) which has Ø3.25 tapered implants with similar shape, lengths, thread, flutes, taper, apex, collar, and connection interface. Dimensional analysis was performed. |
| Mechanical Performance | Dynamic compression-bending to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) was performed. No specific performance metrics (e.g., fatigue cycles, load limits) are presented in this summary, but the test was used to demonstrate equivalence. |
| Sterilization | The sterilization method (Gamma radiation) is the same as predicate devices (K163060, K163634) and was validated per ISO 11137-1 and ISO 11137-2. Moist heat sterilization for end-user sterilized devices was validated per ISO 17665-1 and ISO 17665-2. The Limulus Amebocyte Lysate (LAL) test for bacterial endotoxin (USP 39-NF 34 ) was conducted. |
| Packaging & Shelf Life | Packaging is the same as predicate devices and was validated per ISO 11607. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life. |
Study Details (Based on Information Provided)
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical tests (engineering analysis, dimensional analysis, dynamic compression-bending tests, biocompatibility testing, sterilization validation, packaging validation) and comparison to predicate devices, not a clinical "test set" of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.
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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. This is a submission for a dental implant and accessories, which are physical medical devices, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical "ground truth." For non-clinical tests, "ground truth" would correspond to established engineering standards (e.g., ISO 14801 for fatigue testing, ISO 11137 for sterilization) and established material properties, which serve as the reference for successful performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device submission.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device submission.
Summary of what was done:
The submission uses non-clinical data including:
- Engineering analysis
- Dimensional analysis
- Dynamic compression-bending tests to ISO 14801 for mechanical performance.
- Biocompatibility testing to ISO 10993-1 and ISO 10993-5.
- Sterilization validation to ISO 11137-1, ISO 11137-2, ISO 17665-1, and ISO 17665-2, and bacterial endotoxin testing (USP 39-NF 34 ).
- Packaging validation to ISO 11607 and accelerated aging per ASTM-F-1980 to demonstrate a 5-year shelf life.
The primary method of demonstrating device performance and meeting the implicit "acceptance criteria" of safety and effectiveness for a 510(k) submission is through "substantial equivalence" to legally marketed predicate devices, particularly K163060 (Southern Implants Deep Conical Implants and Accessories) and K163634 (Southern Implants External Hex Implants and Accessories), and K120414 (Astra Tech AB OsseoSpeed™ Plus). The submission highlights that the subject device shares the same intended use, similar technological characteristics, same materials, manufacturing methods, sterilization methods, and packaging as the predicate devices.
§ 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.