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This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

The Fassier-Duval Telescopic IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Peqa Medical Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized Ø3.2 – Ø6.4 stainless steel Fassier-Duval implant components. All subject components have previously been cleared as non-sterile implants. All other components of the Fassier-Duval Telescopic IM System will remain non-sterile to be sterilized by end-user.

This document is a 510(k) Premarket Notification summary for a medical device called the Fassier-Duval Telescopic IM System. It is a submission to the FDA regarding a change to an already cleared device, specifically the addition of gamma sterilized stainless steel components.

Based on the provided information, there is no study to prove the device meets acceptance criteria in the traditional sense of an AI/software performance study for which the specified information (sample sizes, ground truth experts, etc.) would be provided.

Instead, this document describes a renewal/modification to an existing device (K020885 & K041393) where the primary change is the sterilization method and packaging for certain components. The "acceptance criteria" here relate to the successful validation of this new sterilization and packaging process, and adherence to established regulatory and engineering standards.

Here's a breakdown of the requested information based on the provided text, while noting that most of the requested parameters are not applicable to this type of submission:

1. Table of acceptance criteria and reported device performance:

Notes:

• The "device performance" in this context refers to the validated efficacy and safety of the new sterilization and packaging process, not clinical outcomes or algorithmic performance.
• The primary "acceptance criteria" for the original device are related to its mechanical properties, biocompatibility, and functionality as an intramedullary fixation rod, which are not explicitly detailed in this document but were part of the previous 510(k) clearances (K020885 & K041393).

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

• Not applicable (N/A) in the context of an AI/software performance study. For sterilization validation, the "sample size" would refer to the number of devices or test units subjected to the sterilization and packaging validation tests. This specific number is not provided in the document.
• Data Provenance: The tests for sterilization and packaging would have been conducted internally by Pega Medical Inc. or by a contracted laboratory. The document does not specify country of origin for these test results.

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

• N/A. This information pertains to studies where human experts establish ground truth for clinical data, which is not applicable here. Sterilization validations are typically performed by qualified microbiologists and technicians following established protocols.

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

• N/A. Adjudication methods are used for resolving disagreements among multiple human readers of clinical data. This is not relevant to sterilization validation.

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:

• N/A. This device is a physical medical implant, not an AI/software device. No MRMC study was conducted.

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

• N/A. This device is a physical medical implant, not an AI/software algorithm.

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

• N/A. In the context of sterilization and packaging, the "ground truth" would be established by validated scientific and regulatory standards (e.g., successful sterilization to a defined sterility assurance level, successful package integrity, acceptable endotoxin levels).

8. The sample size for the training set:

• N/A. This is a physical device, not an AI algorithm requiring a training set.

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

• N/A. (See point 8)

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