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The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.

The Renovo Life Small Bone IM Nail System nails are available in diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and either solid or cannulated and materials are surgical grade stainless steel or titanium. Renovo Life Screws are 3.5 mm in diameter and are available in lengths from 10mm to 34 mm in materials of surgical grade stainless steel or titanium. The Renovo Life Small Bone IM Nail System is provided non-sterile and are intended for single use only.

The provided text is a 510(k) premarket notification for a medical device called the "Renovo Life Small Bone IM Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance or safety through extensive clinical trials for novel devices.

Therefore, the acceptance criteria and study information requested, particularly regarding performance metrics, sample sizes for training/test sets, expert ground truth, and AI-related studies, are not applicable to this document because it describes a traditional medical device demonstrating substantial equivalence, not an AI/ML-driven device with performance metrics.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics in the way an AI/ML device submission would. Instead, it relies on demonstrating mechanical equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. The "test set" here refers to mechanical testing, not a dataset of patient cases. The document mentions "comparative testing" with a predicate device.
• Data Provenance: Not applicable in the context of patient data. The testing involved mechanical tests and a cadaveric implant trial. No information on the provenance of cadaveric material is provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth in this context refers to the expected mechanical behavior according to standards, not expert interpretations of clinical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling expert disagreements in clinical data labeling. Mechanical tests are typically performed according to established protocols with objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is specifically for evaluating the impact of AI on human reader performance. This device is not an AI/ML device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This device is a physical intramedullary nail system, not an algorithm.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be the established performance characteristics and behavior of the predicate device and the specified ASTM standards.

8. The Sample Size for the Training Set:

Not applicable. No training set is involved as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set or associated ground truth for training.

In summary, the provided document is a 510(k) summary for a conventional medical device (intramedullary nail system). It demonstrates substantial equivalence primarily through material specifications and mechanical testing against a predicate device, rather than through clinical performance metrics or AI/ML specific evaluations.

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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:

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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