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The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, and sheets.

In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

DePuy Synthes RAPIDSORB IPS Injectable Polymer System consists of a sterile resorbable polymer, 85:15 Poly (L-lactide co-glycolide) and a battery powered delivery device. The polymer can be extruded from the delivery device into a predrilled pilot hole at the surgical site.

The polymer is presented as a rod in a sterile package (cartridge) that fits into the delivery device. The device then briefly heats the polymer at the implant site beyond the glass transition temperature of the polymer, allowing the polymer to be extruded in a controlled manner in a preselected length from the device through a plate, mesh, or sheet and into a predrilled hole at the site of the defect. The extruded polymer fills the predrilled hole. Retention is attained through friction and interdigitation with the surrounding bone.

The delivery device consists of three principal components: 1) a Power Drive Unit, which is nonsterile and reusable, and which fits into and is enclosed by 2) a disposable, sterile, single-use, rigid plastic shell and cap, and 3) a sterile, single-use, battery pack that attaches to the shell and serves as the power source. The delivery device is comfortably shaped and balanced to fit the left or right hand of the surgeon.

Enclosing the Power Drive Unit thus assures sterile delivery of the polymer at the implant site. The brevity of the increase in the temperature of the polymer combined with the controlled, minimized volume of polymer implanted prevents tissue injury or necrosis at the implant site.

The given text describes the DePuy Synthes RAPIDSORB Injectable Polymer System (IPS) and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does NOT include a table of acceptance criteria for specific performance metrics nor does it directly list "reported device performance" against such criteria. Instead, it summarizes the conclusions of various nonclinical, in vitro, and animal studies.

Here's an attempt to extract the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. The "Conclusion" sections for each test type indicate whether the device "Passed" or met a comparative standard (e.g., "identical to the cleared polymers," "significantly greater," "superior," "comparable").

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Biocompatibility (Guinea Pig, Intra-cutaneous Reactivity, Acute Systemic Injection): Guinea pigs (number not specified, but stated as "Guinea pigs were injected...", "Test animals were topically patched...", implying multiple). Rabbits (three male NZW rabbits). Mice (number not specified, but "Mice were treated...").
  • In Vitro Axial Pullout Test: "two different IPS fasteners lengths" compared to "a 1.5 x 3mm (length) Direct Drive Lactosorb Screw." (Specific number of samples per group not specified).
  • In Vitro Shear Testing: IPS fastener compared to predicate Lactosorb Fastener. (Specific number of samples per group not specified).
  • Immature Ovine Model Animal Test: Number of animals used for the study is not specified, but the study was conducted in an "immature ovine model."
• Data Provenance: The studies are nonclinical (in vitro bench tests, animal tests, and laboratory tests) and are likely prospective studies conducted specifically for this 510(k) submission. The country of origin for the data is not specified, but the submitting company is based in West Chester, Pennsylvania, USA.

3. Number of Experts and Qualifications

This document does not describe the use of human experts to establish ground truth for a test set in the context of diagnostic accuracy. The studies described are engineering, material science, and animal studies, not interpretive diagnostic studies.

4. Adjudication Method

Not applicable for the types of studies described (nonclinical, in vitro, and animal studies).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes the evaluation of a medical device (a polymer system for craniofacial repair), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

No. This device is a polymer system, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth or reference standard for these studies is based on:

• Standard biological responses (e.g., absence of toxicity, sensitization, irritation for biocompatibility tests).
• Quantitative mechanical measurements (e.g., Newtons for pullout strength, peak load for shear strength).
• Histopathological evaluation of bone and soft tissues in animal models for biocompatibility and healing.
• Chemical identity comparison for controlled extraction studies.
• Compliance with electrical safety standards.

8. Sample Size for the Training Set

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

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