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510(k) Data Aggregation
(135 days)
AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
The AcceleDent® Optima is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Optima should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
The provided text is a 510(k) summary for the AcceleDent® Optima device, which is an orthodontic accessory. It focuses on demonstrating substantial equivalence to a predicate device (AcceleDent® Aura, K153048) rather than presenting a standalone study with clinical acceptance criteria for a new clinical claim.
Therefore, the document does not contain a study that proves the device meets clinical acceptance criteria in the way medical imaging or diagnostic devices typically would. Instead, it demonstrates that the modified device (AcceleDent® Optima) maintains the safety and performance characteristics of its predicate device, primarily through non-clinical (engineering, material, and software) testing.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria listed in the document are primarily for engineering, material, and software verification, ensuring the modified device functions safely and as intended, similar to its predicate. There are no clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in treatment time) with associated acceptance criteria reported in this document.
| Test Category | Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (E): Cytotoxicity | |
| ISO 10993-10:2010(E): Intracutaneous Reactivity Irritation, Maximization Sensitization | ||
| ISO/USP: Acute System Toxicity | "AcceleDent® Optima passed Biocompatibility testing." | |
| Bioburden Enumeration | No identified acceptance criteria (for study purposes only). | "AcceleDent® Optima passed Bioburden Enumeration testing." |
| System Verification | "The full system requirements, which includes the medical device hardware and optional/external mobile application and cloud server software, met the requirements serving as enhancements over Aura." | "AcceleDent® Optima passed System Verification testing." |
| Firmware Unit Test Verification | "The design requirements for the AcceleDent® Optima firmware was tested." (No specific standards mentioned) | "AcceleDent® Optima passed Firmware Unit Verification testing." |
| SubSystem Test Verification | "The medical device hardware met the performance requirements of Aura for therapeutic force delivery, battery charging, usage logging, and environmental operation without the interface of optional/external software." | "AcceleDent® Optima passed SubSystem Verification testing." |
| IEC 60601 3rd ed. (Electrical Safety) | "Each applicable requirement from IEC 60601 3rd was treated as an acceptance criterion for the product and/or documentation." (Ensuring electrical safety for medical devices.) | "AcceleDent® Optima passed IEC 60601 3rd ed. testing." |
| IEC 62133 Battery Safety | "Each requirement from IEC 62133:2012 was treated as an acceptance criterion for the battery and/or documentation." (Covers charging, vibration, temperature cycling, short circuit, free fall, abuse, etc.) | "AcceleDent® Optima passed IEC 62133 Battery Safety testing." |
| Packaging Distribution Testing | ASTM D 4169-14, ASTM D 6198-12, ASTM D3951-10 (Standards for performance testing of shipping containers). | "AcceleDent® Optima passed Packaging Distribution testing." |
| DEHP | "Could contain more than or equal to 0.1% by mass of DEHP as per design requirements." (This appears to be a limit for detection, not an upper limit for presence.) | "AcceleDent® Optima passed DEHP testing." |
| Latex Evaluation | "Test was conducted for study purposed to substantiate the claim that the device is not intentionally manufactured with latex." (No specific acceptance criterion given, but aims to ensure no adverse biological reactions due to latex.) | "AcceleDent® Optima passed Latex testing." |
| HFE-75 (Summative Testing / Human Factors) | ANSI/AAMI HE75:2009/(R):2013 Human factors engineering - Design of medical devices | |
| ANSI/AAMI/IEC 62366:2007/(R)2013 & A1:2013 Medical Devices - Application of usability engineering to medical devices | "AcceleDent® Optima passed Summative testing." (Demonstrates safe and effective use by intended users). | |
| Bluetooth Certification | Bluetooth SIG (Includes approval of BLE RF sub-system performance). | "AcceleDent® Optima passed Bluetooth Certification testing." |
| FCC Compliance Testing | IEC 60601 (specifically EMC testing standards). (Ensuring electromagnetic interference is within approved limits). | "AcceleDent® Optima passed FCC Compliance testing." |
| Physical Properties Testing for Mouthpiece | Hardness DIN ISO 7610 | |
| Density DIN EN ISO 1183-1 | ||
| Tensile Strength DIN 53504/ISO 37 | ||
| Elongation at Break DIN 53504/ISO 37 | ||
| Tear Resistance ISO 34-1 Method B | No specific pass/fail values or ranges reported in this summary, just that the tests were performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test where such information might be relevant (e.g., how many units were tested for biocompatibility, system verification, or human factors). It refers to "the full 3G system" or "the 3G product" as being tested.
The data provenance is from non-clinical testing performed by the manufacturer (OrthoAccel Technology Inc.) and potentially by third-party testing labs (e.g., for certifications like Bluetooth, FCC, IEC standards). The data is retrospective in the sense that it describes tests performed on the device. No country of origin for the internal testing data is specified, but the device is marketed in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a 510(k) submission for a modified orthodontic accessory, relying on engineering and safety testing, not clinical studies requiring expert-established ground truth for a diagnostic outcome. The human factors testing ("Summative Testing") would have involved intended users, but they are not referred to as "experts establishing ground truth" in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations for a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This device is not an AI-assisted diagnostic tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a physical orthodontic accessory; it does not have a standalone "algorithm-only" performance as would be relevant for an AI or diagnostic software device. Its function is to facilitate tooth movement in conjunction with traditional orthodontic treatment. The "software" aspect refers to data transfer and internal device control, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Established standards and regulations: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ASTM for packaging, Bluetooth SIG, and FCC regulations.
- Design requirements/specifications: for internal system, firmware, and subsystem verifications, ensuring the device meets its intended engineering performance.
- Performance of the predicate device (AcceleDent® Aura): for verifying that the therapeutic force delivery, battery charging, usage logging, and environmental operation are maintained.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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