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StarPore™ implants are intended for the restoration of bony contour in craniofacial defects.
StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.

StarPore™ (previously cleared as PoreStar™ Patient Specific Implants) is a range of anatomically shaped surgical implants manufactured from porous high-density polyethylene (HDPE). The star ("Star-") shaped particles create an interconnecting porous ("-Pore") architecture resembling trabecular bone. The implants are provided sterile and intended for single-use. StarPore™ is manufactured from medical grade HDPE (an electrically nonconductive and nonmagnetic polymer) and is suitable for use during Magnetic Resonance Imaging (MRI).
The purpose of this Traditional 510(k) submission is to add "off-the-shelt" implant options to the StarPore™ product line. These off-the-shelf implants would provide surgeons the options of various sizes of implants which, unlike the predicate, would not be individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. Instead, the subject implants would be offered in various off-the-shelf sizes and shapes which could then be cut by the prescribing surgeon intra-operatively to create an anatomically matched patient specific design.
StarPore™ is intended for single use only and is provided sterile, using ethylene oxide gas.

This document, K200532, is a 510(k) premarket notification for the StarPore™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with acceptance criteria in the typical sense of diagnostic or AI-driven device evaluation.

The StarPore™ device is a range of anatomically shaped surgical implants made from porous high-density polyethylene (HDPE), intended for restoring or augmenting bony contour in craniofacial defects. The current submission is for "off-the-shelf" implant options, which can be cut by surgeons intra-operatively.

Given the nature of this submission, the provided information does not include a traditional performance study with accuracy metrics, sensitivity, specificity, etc., as would be expected for a diagnostic or AI device. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037) based on intended use, technological characteristics, material, and performance.

Here's an attempt to address your requests based on the provided text, while acknowledging that many points related to AI/diagnostic device performance studies are not applicable:

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

Based on the provided text, specific quantitative acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for StarPore™ are not explicitly stated or reported in the context of a new performance study. The submission relies on "substantial equivalence" to a predicate device.

The "performance" documented here refers to the equivalence of the characteristics to the predicate.

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

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted. The assessment is based on substantial equivalence to a predicate device and a risk analysis.

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)

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted which would require ground truth established by experts.

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

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted.

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

This information is not applicable. StarPore™ is a physical surgical implant, not an AI or diagnostic tool that would involve human readers or comparative effectiveness studies of this nature.

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

This information is not applicable. StarPore™ is a physical surgical implant, not an algorithm.

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

This information is not applicable as no new performance study (in the context of AI/diagnostic evaluation) was conducted. The "ground truth" for this substantial equivalence submission would be the established safety and effectiveness of the predicate device (K171037) through its previous clearance, and the assessment that the new device does not introduce new questions of safety or effectiveness.

8. The sample size for the training set

This information is not applicable as StarPore™ is a physical surgical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable as StarPore™ is a physical surgical implant, not an AI or machine learning model.

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The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

The PoreStar Patient Specific Implants are a range of anatomically shaped, patient specific surgical implants manufactured from high density polyethylene (HDPE) to the reconstructive boundaries indicated by the surgeon. The interconnecting porous ("Pore-") architecture created from a star ("-Star”) shaped particle resembles trabecular bone and permits tissue ingrowth into the implant. PoreStar Patient Specific Implants are individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. The PoreStar Patient Specific Implants are provided sterile and intended for single-use.

The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects. The submission demonstrates substantial equivalence to a predicate device, the MEDPOR Customized Surgical Implant (K083621).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a stand-alone "acceptance criteria" table with corresponding "reported device performance" in the typical sense for clinical performance. Instead, it focuses on non-clinical testing to demonstrate equivalence to a predicate device. The acceptance criteria are implicitly met if the results of all non-clinical tests are successful and demonstrate substantial equivalence.

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

This submission relies on non-clinical bench testing to demonstrate substantial equivalence, rather than clinical data or a "test set" of patient cases, as would be typical for an AI/ML device. Therefore, a sample size for a test set of patient data, data provenance, retrospective/prospective nature, number of experts, or adjudication methods are not applicable to this type of submission.

The "samples" used were for the various material and mechanical tests (e.g., test specimens for tensile, flexural, and pull-out tests, packaging samples for integrity and shelf-life tests). The specific number of samples for each test is not detailed in the provided summary but would be standard for compliance with the cited ASTM and ISO standards. The provenance of these test samples (e.g., where the HDPE material was manufactured) is not given.

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, as this is a non-clinical bench testing submission for a physical implant.

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

Not applicable, as this is a non-clinical bench testing submission for a physical implant.

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 device is a passive implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a passive implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in the ASTM and ISO documents. For example:

• Material Safety: Compliance with biocompatibility limits defined by ISO 10993 standards.
• Mechanical Integrity: Measured mechanical properties (e.g., tensile strength, flexural strength) meeting established material specifications or being equivalent to the predicate device’s properties.
• Sterilization: Sterility assurance levels (SAL) and residual limits defined by ISO 11135-1, 11737-1, and 10993-7.
• Shelf-life: Packaging integrity and mechanical properties after accelerated aging meeting predefined acceptance criteria referenced in ASTM F1980-07, ASTM F88-09, ASTM F1929-98, ASTM F1929-12, ASTM F1929-15, ASTM F2096-11, ISTA 2A.

8. The sample size for the training set

Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set.

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

Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set or its associated ground truth establishment.

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The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.

This 510(k) premarket notification describes a medical device, the MEDPOR® Customized Surgical Implant, and seeks to demonstrate its substantial equivalence to a predicate device, the MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implants.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific strength/durability for an implant). Instead, the acceptance criteria in this context are primarily focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions.

The table presented in the document itself serves as the core of this comparison:

Reported Device Performance:
The document doesn't report specific quantitative performance metrics for the customized implant that would be typically seen in a study evaluating a device's effectiveness or safety against numerical criteria. Instead, the performance is implicitly demonstrated by showing that the customized implant shares fundamental characteristics (material, intended use, sterilization, biocompatibility, etc.) with a legally marketed device known to be safe and effective. The key difference noted is the customization aspect (patient-specific shapes) and the associated absence of a "Non-Pyrogenic Claim" and a specific labeling change reflecting "not tested for endotoxin."

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

The provided documentation does not describe a clinical study or a test set in the traditional sense that would involve a sample size of patients or data for evaluation. The "study" here is a comparison of characteristics between the new device and the predicate device, not an empirical performance trial with a patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective do not directly apply to this type of regulatory submission. The data provenance is primarily the design specifications and manufacturing information of the device itself and the predicate.

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)

This regulatory submission (510(k)) does not involve the establishment of a "ground truth" by experts in the context of a clinical study or algorithm evaluation. The "ground truth" for demonstrating substantial equivalence is the predicate device's known characteristics and regulatory clearance. The experts involved are primarily the manufacturer's R&D, regulatory, and quality assurance teams who have compiled the technical specifications and performed the comparison, and subsequently, the FDA reviewers who evaluate the submission. Their qualifications are not detailed here, but they would be regulatory and scientific experts.

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

As there is no clinical or performance test set described that requires expert review and adjudication, this information is not applicable to this document. The "adjudication" is the FDA's regulatory review process.

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

This is not applicable. The device is an implant for craniofacial defects, not a diagnostic imaging device involving human readers or AI assistance.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

As explained above, the "ground truth" in this context is the established characteristics and regulatory clearance of the predicate device. The manufacturer demonstrated that their new customized implant has substantially equivalent characteristics for safety and effectiveness.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI model that requires a training set.

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

This is not applicable as there is no training set for an AI model.

Ask a specific question about this device

Ask a specific question about this device