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510(k) Data Aggregation
(210 days)
HTW
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
Renovo Life Hard Carbon Coated Drill Bits are available in diameters ranging from 1.1 mm to 8.0 mm, lengths ranging from 60 mm to 300 mm, and either solid or cannulated. The drill bits are designed with a standard connections.
Renovo Life Hard Carbon Coated Drill Bits are made of surgical grade stainless steel. The bone-cutting portion of the drill is coated with a hard carbon coating.
Renovo Life Hard Carbon Coated Drill Bits are provided non-sterile and are intended for single use only.
The Renovo Life Hard Carbon Coated Drill Bit is a medical device used to cut bone prior to the insertion of bone screws or guide pins. The device's acceptance criteria are demonstrated through a series of non-clinical tests, as no clinical testing was performed.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Test Standards/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 (various parts) | The device's materials (surgical grade stainless steel with a hard carbon coating) are considered biocompatible. The submission indicates these tests were conducted, and based on the substantial equivalence claim, it can be inferred the device met these criteria. The specific results are not detailed in the provided text. |
| Cytotoxicity | ISO 10993 | Performed |
| Maximization Sensitization | ISO 10993 | Performed |
| Intracutaneous Study | ISO 10993 | Performed |
| Systemic Toxicity | ISO 10993 | Performed |
| Sterilization | ANSI/AAMI/ISO 17665-1:2006 (EN ISO 17665-1:2006) (Parts I & II) | Performed. The device is provided non-sterile, but validation of sterilization methods for reprocessing is crucial. |
| Accelerated Aging | ASTM F1980-07 (for 1 year) | Performed. Supports the longevity claims for the device. |
| Mechanical Integrity of Coating | No Standards for this test (implied internal specifications/comparison to predicate) | Performed to show the "coating provided an adequate interface for drilling bone and demonstrated reduced heating and improved resistance to fatigue (longevity)." Specific quantitative results are not detailed. |
| Wear Surface Analysis of Drill Bits | ASTM F1877 - guideline for methods and comparison (implied comparison to predicate) | Performed, specific results not detailed, but contributes to the claim of "reduced heating and improved resistance to fatigue (longevity)." |
| Material Composition | Surgical grade stainless steel conforming to ASTM F899 | Device is made of surgical grade stainless steel. (This is a compliance statement, not a performance test result per se, but fundamental to acceptance). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample sizes used for each of the non-clinical tests (biocompatibility, sterilization, accelerated aging, mechanical integrity, wear surface analysis). It only mentions "A comprehensive series of tests were conducted on the Renovo Life drill bits coated with a hard carbon coating (manufactured by BioMedFlex LLC.). Testing was performed on uncoated, coated, and aged coated Renovo Life drill bits."
- Data Provenance: The tests were conducted internally/contracted by Renovo Life LLC or BioMedFlex LLC. The country of origin of the data is not specified, but the companies are U.S.-based (Renovo Life LLC in Belmont, NC; Orgenix LLC in Douglassville, PA). The data is prospective in the sense that the tests were specifically designed and executed to evaluate this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- This information is not applicable as the provided text describes non-clinical performance testing of a physical medical device, not a diagnostic algorithm or imaging system requiring expert interpretation. The "ground truth" for these tests would be objective scientific measurements and compliance with established standards.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reasons as point 3. Testing involves objective measurements against predefined standards, not expert adjudication of subjective assessments.
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:
- This information is not applicable. The device is an orthopedic manual surgical instrument (a drill bit), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Standardized biological responses as defined by ISO 10993.
- For sterilization: Validation against sterilization cycle parameters and microbial kill as defined by ANSI/AAMI/ISO 17665-1.
- For accelerated aging: Physical and mechanical properties maintained within specified limits after exposure to accelerated aging conditions defined by ASTM F1980-07.
- For mechanical integrity and wear surface analysis: Mechanical performance metrics (e.g., drilling efficiency, force, heat generation, fatigue resistance) and surface characteristics compared against internal specifications or predicate device performance.
- For material composition: Material specifications (e.g., ASTM F899 for stainless steel).
8. The sample size for the training set:
- This information is not applicable, as this device is a physical instrument, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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