(183 days)
The PROPEL Device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.
The PROPEL Device has a stainless steel drill tip with an outer diameter (drill bit OD) of 1.6 mm that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth (0, 3, 5, or 7 mm), thus preventing the drill tip from penetrating the bone beyond the targeted depth when used for osteotomies during dental operative procedures. The handle contains the red LED operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.
The provided text is a 510(k) summary for the PROPEL Device, which is a manual bone drill used in orthodontics and dental operative procedures. The submission is focused on demonstrating substantial equivalence to a predicate device (K150392).
Based on the provided information, the device is a manual bone-cutting instrument, not an AI or imaging device, and therefore the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC) and an MRMC study are not applicable in this context. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and bench testing performed to ensure the device's functional integrity and safety.
Here's an analysis of the provided text in relation to your request, with an emphasis on why certain aspects of your prompt are not present or applicable given the nature of this medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" with quantitative performance metrics in the way one would for an AI algorithm's diagnostic performance. Instead, it relies on demonstrating that the proposed device is substantially equivalent to its predicate. The "performance" is implicitly tied to meeting the same standards as the predicate and the general expectations for such a device.
Here's how we can extract the implicit acceptance criteria and reported performance:
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Equivalence to Predicate | The proposed device has identical intended use, technological features, design, and materials as the predicate device (K150392). The only change is an addition to the indications for use. |
| Biological Safety/Biocompatibility | Biocompatibility data for the predicate PROPEL Device demonstrates compliance with FDA Guidance Document, ISO 10993-1. (Since no changes were made to the device, this data is considered applicable to the proposed device). |
| Sterilization Efficacy & Shelf-Life | Sterilization validation (according to ISO 11137-1, -2, -3 to ensure a SAL of 10-6) and shelf-life validation (according to ASTM F1980-07) were conducted for the predicate device, validating a 2-year shelf-life. (Again, applicable to the proposed device due to no changes). |
| Electrical Safety | Electrical safety testing for the predicate PROPEL Device was conducted in compliance with IEC 60601-1 and IEC 60601-1-2. (Applicable to the proposed device). |
| Mechanical Performance & Reliability | Bench testing for the predicate PROPEL Device demonstrated compliance with product specifications, medical community expectations, and product labeling. Specific tests mentioned: |
- Bit reliability, including deflection resistance and hole depth repeatability
- Various tensile and compression tests of components
- Dial and bit depth reliability
- LED light reliability (Applicable to the proposed device, as no changes were made apart from the added indication). |
| Ability to Create Micro-osteoperforations (New Indication) | Clinical studies demonstrate that the PROPEL Device (which is the same device as the predicate) can be used as a tool to create micro-osteoperforations (OD 1.6 mm and depth of 0, 3, 5, and 7 mm). This is the key "performance" demonstration for the new specific indication. The document states "performance testing supports the subject device for the proposed indications for use" in the "Substantial Equivalence Conclusion." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many bits were tested for reliability, how many devices for electrical safety). It refers to "bench testing" and "clinical studies" but doesn't provide numbers of subjects or devices.
- Data Provenance: Not specified. Given it's a medical device, the studies would typically be conducted under Good Laboratory Practice (GLP) or similar standards. The clinical studies mentioned are stated to "demonstrate that the PROPEL Device (1) can be used to manually drill holes... and (2) can be used as a tool to create micro-osteoperforations." This suggests a prospective design for clinical evaluation, but details like location (country), number of subjects, or how the studies were conducted are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here. Ground truth in the context of an AI device typically refers to definitive labels or diagnoses from experts or pathology to train/evaluate the AI. For a manual surgical instrument, "ground truth" would be established by the physical and mechanical properties of the device, its manufacturing specifications, and its ability to perform its intended function in a clinical setting (i.e., successfully drilling holes/micro-osteoperforations). The "experts" are the engineers and clinicians who conducted and evaluated the bench and clinical studies, ensuring the device met its functional requirements and safety standards. Their qualifications are implicit in the fact that the studies were conducted within a regulated medical device development framework.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is a method used for resolving discrepancies in expert labeling for AI training/evaluation datasets.
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:
Not applicable. The PROPEL Device is a manual instrument, not an AI or imaging diagnostic tool that assists human "readers." The "clinical studies" mentioned are to show the device's capability, not to compare human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI algorithm. Its "standalone" performance is its mechanical and electrical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" would be:
- Engineering Specifications: For dimensions, material properties, electrical function (LED light).
- Standardized Test Methods: Compliance with ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, and mechanical performance.
- Clinical Observation/Functionality: Evidence from clinical use showing that the device can manually drill holes and create micro-osteoperforations as intended, to the specified depths and diameters.
8. The sample size for the training set:
Not applicable. This device does not use an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. No AI training set is involved.
Summary of Key Takeaways from the document relevant to your request:
The fundamental premise of this 510(k) submission is that the proposed device is substantially equivalent to a previously cleared predicate device. This means that:
- The non-clinical testing already performed for the predicate device (biocompatibility, sterilization, electrical safety, bench testing for mechanical reliability) supports the proposed device because there are no changes to its core design, materials, or underlying technology.
- The only new element is the explicit addition of "micro-osteoperforations" to the indications for use. For this specific addition, the document states that "performance testing supports the subject device for the proposed indications for use," and "Clinical studies demonstrate that the PROPEL Device... can be used as a tool to create micro-osteoperforations." This implies that the clinical studies provided sufficient evidence for this expanded indication without needing a full de novo clearance or a different type of study, given the device's existing clearance for drilling holes in bone.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.