(99 days)
The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts
The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone
The device in question is the DReal™, a handheld bone-removal device. The provided document is a 510(k) Pre-market Notification for the DReal™, demonstrating its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary indicates that for each performance test, the device "passed the test" and "The acceptance criteria were met." However, specific quantitative acceptance criteria values are generally not detailed in this type of summary. The table below lists the performance tests and the reported results:
| Test | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| GLP Cytotoxicity per ISO 10993-5 | Non-cytotoxic (less than grade 2 reactivity) | Non-cytotoxic |
| ISO- intracutaneous in Rabbits (irritation) per ISO 10993-10 | Not irritant (difference between test article extract and control is low) | Not irritant |
| Sensitization per ISO 10993-10 | Not considered a sensitizer (no evidence of delayed dermal contact) | Not considered a sensitizer |
| Systemic toxicity per ISO 10993-11 | Nontoxic (no mortality or evidence of systemic toxicity) | Nontoxic |
| Systemic toxicity USP pyrogen Study per ISO 10993-11 | Nonpyrogenic (total rise of rabbit temperatures within USP limits) | Nonpyrogenic |
| LAL test per NAMSA LAL SOP | Acceptable (less than 0.06 EU/ml) | Acceptable |
| Sterilization, Packaging, and Shelf Life Testing | ||
| Sterilization validation (ISO 11137-1) | Compliance with ISO 11137-1 | Successfully completed |
| Shelf life and packaging testing (including integrity, simulated use) | Support for labeled shelf life and packaging integrity | Successfully completed |
| Performance Testing | ||
| Simulated use testing (material removal, durability, integrity on hard tissue) | Efficacy, durability, and integrity for bone removal in clinical settings | Passed the test |
| Temperature Testing (tissue necrosis) | Compliance with safety requirements regarding tissue necrosis | Passed the test |
| Slippage testing (motor compatibility) | Compatibility with specified motors | Passed the test |
| Simulated distribution testing/transportation validation (Chatter testing) | Compatibility with ASTM D4169-09 and ASTM D4332-13 | Passed the test |
| Fatigue test (durability on hard tissue) | Durability and integrity for intended use | Passed the test |
| Motor compatibility | Compatibility with specified motors | Passed the test |
| Excessive Vibration | Compatibility with specified motor without malfunction | Passed the test |
| Animal Feasibility Test (safety and performance in spine) | Safety and performance for intended use in the spine | Passed the test |
| Cadaver Feasibility Test (performance in spine) | Performance for intended use in the spine (gross bone volume reduction) | Passed the test |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The sample sizes are specific to the biological tests performed (e.g., rabbits for irritation, guinea pigs for sensitization, mice for systemic toxicity). Specific numerical sample sizes beyond the general animal models are not explicitly stated in this summary.
- Sterilization, Packaging, and Shelf Life Testing: Sample sizes are not specified, but the tests were performed on device samples.
- Performance Testing:
- Animal Feasibility Test: One live adult (7 months) pig.
- Cadaver Feasibility Test: One skeletally mature human cadaver.
- For other performance tests (simulated use, temperature, slippage, chatter, fatigue, motor compatibility, excessive vibration), the sample size of devices tested is not specified in this summary.
- Data Provenance: Not explicitly stated, but given the manufacturer is Carevature Medical Ltd. in Israel, it is likely that the testing (especially feasibility tests) was conducted there or arranged through a contract research organization. The studies are assumed to be prospective as part of the premarket notification process for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is not typically required or provided in a 510(k) summary for mechanical surgical devices. The "ground truth" for these tests primarily relies on objective measurements against established engineering and biological standards (e.g., ISO, ASTM, USP standards) and direct observation by qualified technicians and researchers conducting the tests.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic or AI-based devices. For this mechanical surgical device, the "adjudication" is inherent in passing or failing objective engineering and biocompatibility tests against predefined standards. There is no mention of a separate expert adjudication process for these tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret images, and the AI's assistance to human readers is evaluated. The DReal™ is a surgical tool, not a diagnostic imaging AI.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The DReal™ is a mechanical surgical device operated by a surgeon, not an algorithm. Its performance is evaluated through its physical properties, safety, and functionality, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for this device is based on several objective measures and established standards:
- Biocompatibility: In vitro and in vivo testing against ISO and USP standards.
- Sterilization, Packaging, and Shelf Life: Validation against ISO standards.
- Performance Testing (Simulated Use, Temperature, Fatigue, etc.): Objective measurements of mechanical properties, material removal efficacy, temperature generation, durability, and compatibility against predefined engineering specifications and regulatory standards (e.g., ASTM).
- Feasibility Tests (Animal and Cadaver): Direct observation of safety, performance, and gross bone volume reduction in a controlled environment.
8. The Sample Size for the Training Set
This question is not applicable. The DReal™ is a mechanical device, not an AI or machine learning algorithm that requires a training set. Its design and manufacturing are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this mechanical surgical device.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).