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The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

This document is a 510(k) premarket notification for the MacroPore Surgical Barrier Film. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested categories (like MRMC study, sample size for training set, number of experts for ground truth) are not applicable or directly derivable from this type of document.

However, I can extract the "acceptance criteria" through the lens of proving substantial equivalence, which revolves around demonstrating similar performance to predicate devices, and the "study" is the in vitro testing and comparison described.

Here's the information formatted to the best extent possible given the document type:

Acceptance Criteria and Device Performance for MacroPore Surgical Barrier Film

Note: This document is a 510(k) for substantial equivalence, not a clinical trial report. "Acceptance criteria" are inferred from the requirements for substantial equivalence, and "reported device performance" refers to the results of the described in vitro tests and comparisons to predicate devices. A "study" in this context refers to the non-clinical testing performed to support the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as this is non-clinical testing. The "test set" would refer to the samples of the MacroPore Surgical Barrier Film subjected to in vitro heating, aging, and mechanical tests. The number of samples tested for each specific test (e.g., viscosity, tensile strength) is not quantified in this summary.
• Data Provenance: The data is from in vitro laboratory testing performed by MacroPore Biosurgery, Inc. It is considered prospective in the sense that the tests were specifically conducted for this 510(k) submission. Country of origin for data generation is likely the USA, implicitly where the manufacturer is located (San Diego, CA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable / not provided. This is an in vitro device and a 510(k) submission. It does not involve human subjects or expert assessment for establishing "ground truth" in a clinical sense. The "ground truth" for the material properties would be established by standard engineering and materials science principles and testing protocols.

4. Adjudication Method for the Test Set

• Not applicable / none. Since the "test set" refers to in vitro measurements against established material science parameters and comparisons to predicate device specifications, there is no need for expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is a type of clinical comparative effectiveness study involving multiple human readers evaluating diagnostic cases. This document describes an in vitro device and a 510(k) submission for substantial equivalence based on material properties and design, not diagnostic accuracy requiring human reader performance.

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

• Partially applicable, but in a non-AI context. The "standalone" performance here refers to the intrinsic material and mechanical properties of the device itself (e.g., its viscosity retention, strength, malleability, dimensions) as measured in laboratory tests, without human interaction beyond the initial setup and measurement. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

• Engineering and Material Science Standards / Predicate Device Specifications. The "ground truth" for the in vitro tests is derived from:
  • Established scientific principles for material behavior (e.g., viscosity, mechanical strength).
  • Comparison to the known performance and specifications of legally marketed predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant).
  • The assumption that the predicate devices are safe and effective for their intended use.

8. The Sample Size for the Training Set

• Not applicable / No training set in the AI sense. This is not an AI/machine learning device. The "training" for the device itself would refer to its manufacturing and design process, informed by polymer science and surgical needs, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI training set, this question is not relevant. The device's design and material selection are based on established engineering principles, material properties of polylactides, and the functional requirements for an orbital implant wrap, with reference to predicate devices.

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Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.

Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde.

Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm.

Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.

This 510(k) submission (K973552) for Ocu-Guard™ and Supple Ocu-Guard™ Orbital Implant Wrap does not contain detailed acceptance criteria or a specific study proving the device meets stated acceptance criteria in a format directly comparable to modern AI/ML device submissions. Instead, it relies on a demonstration of substantial equivalence to predicate devices. Therefore, the requested output in the format of acceptance criteria and device performance based on a standalone study cannot be fully extracted.

However, based on the provided text, we can infer the principles of acceptance and the types of studies performed to support the claim of substantial equivalence.

Here's an interpretation of the document in the requested format, with explanations where direct information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Rabbit Ocular Implant Studies: Sample size is not specified. Likely retrospective, as it refers to a "study" without details on its design or start/end dates for this specific 510(k). Data provenance: Not specified (but likely within the US given the submission to FDA).
• Canine Implant Studies: Sample size is not specified. Likely retrospective. Data provenance: Not specified.
• Clinical Report: "Preliminary clinical data" is mentioned, sample size not specified. Likely retrospective from existing clinical use of the bovine material (Peri-Guard and Supple Peri-Guard). Data provenance: Not specified.

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

This document does not describe "ground truth" in the context of expert consensus as relevant to AI/ML devices. The "truth" here is established through pre-clinical (animal) studies and preliminary clinical observations by researchers/clinicians, which are then evaluated by the FDA for substantial equivalence. No specific number or qualification of experts establishing ground truth in this manner is provided.

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

Not applicable. The studies mentioned (animal, preliminary clinical) are experimental observations rather than assessments requiring adjudication of interpretations of data by multiple human readers.

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 submission predates the widespread use of sophisticated AI in medical devices and does not involve human readers interpreting images with or without AI assistance. The focus is on the material's biological and physical performance.

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

Yes, in a sense, the animal studies (Rabbit Ocular Implant, Canine Studies) and the biocompatibility testing can be considered "standalone" evaluations of the device material's performance independent of human intervention in its function. These studies assess the biological and physical properties of the material itself.

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

The "ground truth" for demonstrating substantial equivalence is primarily derived from:

• Histopathological or gross observation in animal studies (e.g., tissue integration, inflammatory response).
• Biocompatibility testing results (standard tests for cytotoxicity, sensitization, irritation, etc.).
• Mechanical and physical testing results of the material characteristics.
• Clinical observations/outcomes data from the "preliminary clinical data" and "history of safety and effectiveness" for the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The "history of safety and effectiveness" and predicate device data can be conceptualized as a vast "experience base" rather than a formally labeled training set.

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

Not applicable, as no training set for an algorithm is involved. The "ground truth" for the historical data of processed bovine pericardium (Peri-Guard, Supple Peri-Guard) would have been established through extensive preclinical and clinical use, including pathology, clinical outcomes, and long-term safety monitoring over two decades (since 1982).

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