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The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.

The RapidFlap™ LS Cranial Flap Fixation System is comprised of three parts, an inner plate, an outer plate and a central post. The inner plate consists of a circular disk through which the post is centrally extruded outwardly. The outer plate consists of a circular disk which a threaded hole to accept the post. The devices are assembled by hand to force the plates together capturing the bone. When applied, the plates tightly grip the bone flap, and provide rigid attachment and coplanar alignment to the surrounding bone. The RapidFlap™ LS System is made from Polylactic / polyglycolic acid copolymer.

The LactoSorb® Heat /Contouring Pen is a disposable alkaline-battery powered device. Two tips are provided with the body or handle of the device. These tips can use the same handle to perform slightly different functions. The long wire tip is used to cut the LactoSorb® plates and the flat surfaced tip is used to smooth the edges of the plates. The device is supplied sterile.

This 510(k) summary (K130309) for the RapidFlap™ LS Cranial Fixation Flap System indicates that no clinical or non-clinical studies were performed to prove the device meets acceptance criteria.

The submission establishes substantial equivalence based on a comparison to predicate devices in terms of design, material, sterilization, and intended use, rather than through performance testing. The purpose of the submission was specifically to extend the indications for use to include adult populations, aligning it with predicate devices.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document as such studies were not conducted or reported in this 510(k).

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. Substantial equivalence was claimed solely based on comparison to predicate devices, not on specific performance criteria met through testing.

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

Not applicable. No test set or clinical study was conducted.

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

Not applicable. No test set or ground truth establishment by experts for performance evaluation was conducted.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication process for performance evaluation was conducted.

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:

Not applicable. This device is a physical medical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

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

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

Not applicable. No ground truth for performance evaluation was established as performance studies were not conducted.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used as this is a physical medical device.

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

Not applicable. No training set for an algorithm was used.

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The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures.

OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites.

OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation

The Synthes OrthoMesh Resorbable Graft Containment System is comprised of meshes of 0.5mm, 0.8mm and 1.2mm thickness, and lengths and widths ranging from 48mm to 125mm. The Synthes OrthoMesh Resorbable Graft Containment System is also comprised of screws with a diameter ranging from 1.5mm to 2.5mm, and a length ranging from 4mm to 8mm. These implants are made from the resorbable copolymer poly (L-lactide-co-glycolide) that resorbs in vivo by hydrolysis into lactic and glycolic acids, and that are then metabolized by the body. Synthes OrthoMesh implants are resorbed completely within approximately 12 months. The implants are provided sterile and are intended for single patient use. OrthoMesh may be held in place with screws.

The provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria.

The document is a 510(k) summary and an FDA clearance letter for the Synthes OrthoMesh Resorbable Graft Containment System. It describes the device, its intended use, contraindications, and declares its substantial equivalence to predicate devices. However, it does not include performance data, clinical study results, or specific acceptance criteria for device performance.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

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