(150 days)
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 6 mm in diameter, from 8 - 18 mm in length and are composed of titanium and hydroxyl-apatite (HA). They are available with a flat or hex lock superior surface, and are either cylindrical or threaded.
This document is a 510(k) summary for a medical device (Steri-Oss 6 mm Diameter HA Coated Implants) and does not describe a study that details acceptance criteria and device performance in the way typically seen for AI/software devices.
Instead, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than providing detailed performance study data against specific acceptance criteria for a novel device.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable (N/A) to this type of document and device.
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in a quantitative, measurable way for the Steri-Oss implant's performance, nor does it report specific device performance metrics in the way a clinical trial or performance study would. It focuses on comparison to a predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated/N/A) | Reported Device Performance (N/A) |
|---|---|---|
| Material Equivalence | Not explicitly stated, but implied: material composition is acceptable for an implant. | Platinum and HA (Steri-Oss) vs. Titanium (Predicate) - This is a characteristic, not a performance metric or acceptance criterion. |
| Dimensional Equivalence | Not explicitly stated, but implied: dimensions are within acceptable ranges for an implant. | Diameter: 6 mm (Steri-Oss) vs. 3.75 mm (Predicate); Length: 8-18 mm (Steri-Oss) vs. 7-20 mm (Predicate) - These are characteristics, not performance metrics or acceptance criteria. |
| Geometric Equivalence | Not explicitly stated, but implied: geometry is acceptable for an implant. | Threaded or Cylindrical (Steri-Oss) vs. Threaded (Predicate) - This is a characteristic, not a performance metric or acceptance criterion. |
| Sterility | Not explicitly stated, but implied: device must be sterile. | "Same" as predicate (Sterile) - This is a characteristic/safety feature, not a performance metric. |
| Functional Equivalence | Not explicitly stated, but implied: designed to serve as support for prosthetic devices to restore patient chewing function. | "A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products." - This is the justification for equivalence, not a direct performance measurement against criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: N/A - No "test set" in the context of clinical performance data is mentioned. The submission relies on a "mathematical justification" for substantial equivalence, not experimental data from a specific test set.
- Data Provenance: N/A - No data is presented in this format (e.g., patient data).
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)
- Number of experts: N/A
- Qualifications of experts: N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: N/A
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
- N/A - This document is for a physical medical implant, not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A - This document is for a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the predicate device (Nobelpharma's 3.75 mm implant). The submission aims to establish that the Steri-Oss implant is substantially equivalent to this existing, legally marketed device.
8. The sample size for the training set
- Sample Size: N/A - No "training set" in the context of machine learning or clinical trials is mentioned. The submission relies on a "mathematical justification" for substantial equivalence.
9. How the ground truth for the training set was established
- Ground Truth Establishment: N/A - There is no training set described. The "ground truth" for the comparison is the design and function of the predicate device, which is an already approved medical device.
§ 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.