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Adjustable Bone Plates™- 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. .

Device Description

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable, Self Compression Bone Fixation plates, meshes, fixation screws, fasteners, tacks, tenion wires and anchor pins designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable, self compression, Bone fixation plates are offered in various sizes and configurations to meet anatomical needs of the patients. TheAdjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation plates, mesh, screws .tension wires, tacks and anchor pins 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 and 2.1 mm screws, tacks and anchor pins for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm conventional screw driver or deployed with endoscopic device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device and not a study that evaluated an AI/ML device. Therefore, the requested information for acceptance criteria and a study proving the device meets them, specifically in the context of AI/ML, cannot be fully extracted.

However, I can provide the information that is present concerning the device's comparison to a predicate device, which is a form of "acceptance criteria" for 510(k) submissions.

Here's a breakdown of what can be extracted, heavily acknowledging the limitations:

No AI/ML device is described in the provided text. The device is a physical craniofacial bone fixation system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate device comparison)	Reported Device Performance
Technological Characteristics: Substantially equivalent to predicate device Xsorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories (K070737) in:	Met. "Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories... is substantially equivalent to the predicated device Xsorb™ Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737."
- Product design	Identical. "the proposed product is substantially equivalent to predicated devices in product design..."
- Materials	Identical. "...materials..."
- Packaging	Identical. "...packaging..."
- Intended Use	Identical. "...and intended use."
- Material compatibility	Met. (Implied by substantial equivalence and material selection being identical)
- Product specifications	Met. (Implied by substantial equivalence)
Mechanical Performance:	Met. "Mechanical testing of the devices also demonstrated that the tensile strength, breakage force and degradation time for the device are equivalent to predicated devices & are satisfactory for its intended use."
- Tensile strength (Equivalent to predicate)	Average Tensile Strength: X= 2.5 Lb / in²
- Breakage Pull force (Equivalent to predicate)	Average Breakage Pull Force: 4.0 Lb/ in²
- Pull force during installation (Less than 1.0 Lb/in²)	Average pull force applied during Adjustable Bone plate installation, using Clamp Tool (with 2.0mm pre-set stops) is less than 1.0 Lb/in².
- Degradation time (Equivalent to predicate)	"The actual degradation time of the proposed and predicate device are practically identical."
Manufacturing Processes:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical."
Sterilization Process:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical."
Indications for Use:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical." Note: The indications for use are explicitly listed and are deemed equivalent to the predicate.

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

Sample Size: Not specified quantitatively. The text only mentions "Preclinical testing was performed" and "Laboratory product testing has indicated that the Adjustable Bone Plates™..." It does not provide specific numbers of units tested for mechanical properties.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is "Preclinical testing" and "Laboratory product testing", suggesting controlled lab environments rather than clinical data.

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

Not applicable. This relates to diagnostic interpretation, which is not relevant for a physical bone fixation system. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication method for the test set

Not applicable. This also pertains to expert interpretation, not physical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. The device described is a physical implant.

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

No. This refers to AI/ML algorithm performance. The device is a physical product.

7. The type of ground truth used

Direct physical measurement/bench testing. The "ground truth" for the mechanical properties (tensile strength, breakage force, degradation time, pull force during installation) was established through laboratory testing and measurement of the device itself.

8. The sample size for the training set

Not applicable. The device is not an AI/ML system that requires a "training set."

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

Not applicable. As above, no training set for an AI/ML model is involved.

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