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General Indication for Use: Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children. Specific Indications for Use: - Fractures of the cranium, mid-face, maxilla and chin. - Infant craniofacial surgery (i.e. Craniosynostosis, Congenital malformations) . - Le Forte ( I, II, III ) Osteotomies. . - Pediatric Reconstructive procedures of Cranial facial Skeleton . - Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. ● - Facial Craniotomy flap fixation. ●

Xsorb™ Bicabsorbable Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable Bone Fixation plates, meshes, fixation screws, fastners and tacks designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable Bone fixation plates and meshes are offered in various sizes and configurations to meet anatomical needs of the patients. The Xsorb™ - Bioabsorbable Craniofacial Bone Fixation pltaes & screws / wires are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ) . The bone plates and meshes are designed to be used with 1.8mm screws and 2.1 mm emergency screws for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm screw driver.

The provided text describes a 510(k) submission for the Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not typically a study proving performance against strict acceptance criteria like those for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of submission.

However, I can extract information related to "performance data" as mentioned in the document for the device itself, rather than an AI/ML algorithm.

Here's a breakdown of the requested information based on the provided text, focusing on what is available and noting what is not applicable for this type of device clearance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the way an AI/ML study would define performance thresholds (e.g., specific sensitivity/specificity targets). Instead, it refers to the device performing "as intended" and being "satisfactory" compared to predicate devices. The "performance" is based on mechanical testing.

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

• Sample Size for Test Set: Not specified. The performance data section refers to "Preclinical testing" and "Laboratory product testing," which typically involves specific test articles (e.g., plates, screws) but doesn't quantify a "sample size" in terms of cases or patients as an AI/ML study would.
• Data Provenance: Not specified. This relates to laboratory testing of the physical device, not patient data derived from a specific geographic location.
• Retrospective or Prospective: Not applicable. The testing described is mechanical/laboratory testing of the device itself.

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

• Not applicable. This device is a physical craniofacial fixation system, not an algorithm that requires expert ground truth labeling. Performance is assessed through mechanical properties.

4. Adjudication method for the test set

• Not applicable. This is not an AI/ML study requiring adjudication of expert opinions.

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. This is not an AI/ML device, so an MRMC study is not relevant or performed.

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

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

7. The type of ground truth used

• Not applicable / Mechanical Properties. The "ground truth" for this device's performance is objective mechanical measurements (tensile strength, breakage force, degradation time) compared against established standards for predicate devices or biomechanical requirements for the intended application.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.

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