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The Remington Medical (RMI) CentreFire 22 Biopsy Instrument is a semi-automatic, reusable, spring-loaded mechanical device that is designed to be used with Remington Medical NAC Biopsy Needles to obtain core biopsy samples from the prostate.

AI/ML Overview

1. Table of acceptance criteria and reported device performance:

The document describes non-clinical performance studies for the Remington Medical CentreFire 22 Biopsy Instrument, focusing on its substantial equivalence to a predicate device, the Medical Device Technologies, Inc. Ultra (K962969). The acceptance criteria for the subject device are implicitly met if its performance is equivalent to the predicate device and meets established requirements for consistent performance and reprocessing.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from study description)	Reported Device Performance
Device Performance: Needle Excursion	Equivalent penetration depth to predicate device; meets established requirements for consistent performance.	The study results demonstrate that the device meets established requirements necessary for consistent performance during its intended use and performs equivalent to the predicate device.
Device Performance: Biopsy Sampling	Equivalent quality/consistency of biopsy samples to predicate device; meets established requirements for consistent performance.	The study results demonstrate that the device meets established requirements necessary for consistent performance during its intended use and performs equivalent to the predicate device.
Reprocessing Validation: Cleaning	Ensures appropriate cleaning methods for the end user and meets established requirements for consistent reprocessing.	The device meets the established requirements necessary for consistent reprocessing.
Reprocessing Validation: Sterilization	Ensures appropriate sterilization methods for the end user (Gravity Displacement Steam Sterilization (Autoclave)) and meets established requirements for consistent reprocessing.	The device meets the established requirements necessary for consistent reprocessing.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for the non-clinical performance studies (Needle Excursion and Biopsy Sampling) or the reprocessing validations.
The data provenance is from internal non-clinical testing performed by Remington Medical, Inc. (prospective, as it was performed for this 510(k) submission). The geographical origin of the data is not explicitly stated, but it would be assumed to be conducted in the USA where Remington Medical Inc. is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring expert consensus for ground truth.

4. Adjudication method for the test set:

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The evaluation was based on non-clinical performance studies demonstrating equivalence to a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (biopsy instrument), not an AI algorithm. The performance testing was for the physical instrument.

7. The type of ground truth used:

For the non-clinical performance studies (Needle Excursion and Biopsy Sampling), the ground truth was established through measurement and observation of physical characteristics and outcomes based on predefined test protocols and acceptance criteria. This would involve objective metrics such as actual penetration depth, visual assessment of sample quality and consistency, etc.

For the reuse/reprocessing validations, the ground truth was established by testing the efficacy of cleaning and sterilization protocols to ensure the instrument consistently met accepted standards for reprocessing (e.g., absence of biological residues, sterility assurance levels).

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a medical device, not an AI algorithm.

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