(85 days)
The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The Restore Orthibiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a bionaterial desived from porcine small intestine. SIS is composed presionshately of water and collagen. This material to the material approved in IDF. G960196 for investigational use as an Anterior Cruciate Ligament (ACL) replacement device and submitted in K974540 for Hernia Repair. The device is intended to act as a resorbable scaffold which initially has sufficient mechanical strength to assist with a soft tissue repair, but then resorbs and is replaced by the patients own tissue.
The provided text is a 510(k) submission summary for the DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information, which is relevant to AI/ML device testing, is not applicable to this document.
However, I can extract the information that is present and indicate where the requested information is not available in the provided text.
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A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the context of specific quantitative acceptance criteria and device performance metrics, as is common for AI/ML device evaluations. The document focuses on showing "comparable" mechanical properties to predicate devices.Acceptance Criteria (Implied) Reported Device Performance Comparable suture retention strength Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable suture retention strength. Comparable mechanical strength (ball burst tests) Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable mechanical strength as measured by ball burst tests. Biocompatibility (ISO 10993 and other standards) Biocompatibility tests, performed according to ISO 10993, other accepted standards and other appropriate test methods indicate that the SIS material is biocompatible. Efficacy for soft tissue repair/replacement (animal studies) Numerous animal efficacy studies indicate that SIS, in various configurations, is efficacious when used for soft tissue repair or soft tissue replacement. Absence of rejection In all animal studies, the SIS implant served as a scaffold for new tissue formation and no evidence of rejection of the material was observed. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document refers to "numerous animal efficacy studies" but does not specify a sample size for an overall "test set."
- Data Provenance: The studies are described as "animal efficacy studies." No country of origin is specified. The nature of these studies (e.g., retrospective or prospective) is not detailed.
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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. The ground truth for this type of device (surgical mesh) is typically established through histopathological analysis in animal studies and clinical outcomes, not expert consensus reading of images or diagnoses. No information on experts establishing ground truth is provided. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for human-read interpretations (e.g., medical image analysis) where multiple experts assess cases. This document describes material and animal studies. -
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 is not an AI/ML device and therefore, no MRMC study or AI assistance evaluation was performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the description of "animal efficacy studies," the ground truth would inherently involve:- Pathology/Histology: Assessing new tissue formation, scaffold resorption, inflammation, and integration in animal models.
- Outcomes Data (Animal Models): Functional outcomes related to the repair (e.g., strength of repair, recurrence of defect).
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The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the sense of machine learning. The "numerous animal efficacy studies" that establish efficacy of SIS material generally pre-date this 510(k) submission, serving as foundational evidence for the material's properties and performance. -
How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned in the context of AI/ML. The evidence used to support the device's efficacy and substantial equivalence comes from scientific studies and established material characteristics of SIS.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.