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The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

RMST Staple is an absorbable polymer strap with cleat tips. RMST Staple is composed of absorbable synthetic polyester derived from lactic acid and dyed with D&C Violet #2. The RMST Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical.

The Rotation Medical Soft Tissue Staple (RMST Staple) was evaluated through a series of in vitro and in vivo tests to establish its safety and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

• Cytotoxicity
• Sensitization
• Intercutaneous reactivity
• Acute systemic toxicity
• Pyrogenicity
• Muscle implantation
• Subchronic toxicity
• Hemolysis |
  | Product Characterization & Bench Testing | Evaluation of general physical properties, including tensile strength and retention strength (pull-out), to demonstrate substantial equivalence to the predicate device. | The RMST Staple underwent in vitro product characterization studies and bench testing. These included assessments of:
• Tensile strength
• Retention strength (pull-out)
• General physical properties (e.g., size, surface area, weight, and strength retention)
  The results demonstrated that the RMST Staple is substantially equivalent to the predicate device, Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device (K093845). |
  | Animal Efficacy Study | Not explicitly stated as acceptance criteria, but performed to demonstrate safety and equivalence. | An animal efficacy study was performed. The results from this study, along with the in vitro and in vivo biocompatibility studies and bench testing, demonstrate that the RMST Staple is safe and substantially equivalent to the predicate devices. |

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

• The document does not explicitly state specific sample sizes for each individual test (e.g., cytotoxicity, tensile strength). The phrasing "a number of in vitro and in vivo tests" suggests a sufficient number were conducted to meet regulatory requirements.
• The data provenance is not explicitly stated in terms of country of origin.
• The studies were likely prospective in nature, as they were conducted specifically for the purpose of demonstrating safety and efficacy for regulatory submission.

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

• This information is not provided in the document. The studies described are primarily laboratory and animal-based, not involving human expert interpretation for "ground truth" in the way a diagnostic AI might.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. The studies described are pre-clinical (in vitro, in vivo animal) and bench testing, not reliant on human adjudication of a specific output like in a clinical diagnostic study.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a surgical staple, not a diagnostic imaging device or an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical surgical staple, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the biocompatibility studies, the "ground truth" would be established by standard scientific and regulatory methods for assessing biological response (e.g., cellular observation for cytotoxicity, macroscopic/microscopic tissue evaluation for implantation studies).
• For the product characterization and bench testing, the "ground truth" would be objective measurements and engineering standards (e.g., force required for tensile strength, displacement for pull-out).
• For the animal efficacy study, the "ground truth" would be pre-defined clinical and histological endpoints observed in the animal models.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI model requiring a training set.

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

• Not applicable, as no training set for an AI model was involved.

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