LACTOSORB SHEETS

• K Number: K992158
• Device Name: LACTOSORB SHEETS
• Manufacturer: BIOMET, INC.
• Date Cleared: 1999-08-20 ( 56 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The LactoSorb® Sheets are used as fixation devices in the following procedures:

A. General Indication: Trauma procedures of the midface or craniofacial skeleton. Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Pediatric midface or craniofacial trauma
4. Orbital floor fractures
5. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
   B. General Indication: Reconstructive procedures of the midface or craniofacial skeleton.

Specific Indications:

1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
2. Tumor reconstruction in midface or craniofacial procedures
3. Bone graft procedures in the midface or craniofacial skeleton
4. Pediatric reconstructive procedures
5. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
6. Craniotomy flap fixation
   C. Mandible Indication: Used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

Device Description

The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid polymer degrades and resors IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resors by 9-15 months.

AI/ML Overview

The provided text is a 510(k) summary for the LactoSorb® Sheets, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this type of submission (510(k)) generally does NOT involve "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one would describe for an AI/algorithm-based diagnostic device.

Instead, the 510(k) process focuses on demonstrating substantial equivalence to an existing, legally marketed device (the predicate device). This often involves comparing technological characteristics, intended use, and performance data (which may include bench testing, biocompatibility testing, or, less commonly, limited clinical data if necessary to demonstrate equivalence). It does not typically involve a formal study with a 'test set', 'ground truth', or 'experts' as you'd find for evaluating AI performance.

Therefore, I cannot extract the information requested in your bullet points because the provided document and the nature of a 510(k) submission for this type of device do not contain that kind of data.

To directly address your request, based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific study within the document. The implicit "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.
   • Reported Device Performance:
     • "The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue."
     • "The material retains its strength for at least 8 weeks and completely resorbs by 9-15 months."
     • Context: These are descriptions of material properties and biological behavior, not performance metrics from a comparative clinical study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. The document does not describe a "test set" in the context of an algorithmic performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

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 MRMC study was done. This device is a physical implant, not an AI diagnostic tool for human readers.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

In summary: The provided document describes a 510(k) premarket notification for a physical medical implant (bioresorbable sheets). The regulatory pathway for such devices, especially from 1999, does not require the types of "acceptance criteria" and "studies" that are relevant to AI/machine learning diagnostic tools. The information you're asking for is specific to AI performance evaluation and is not contained within this document.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.