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510(k) Data Aggregation
(92 days)
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.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate K171037) | Reported Device Performance (StarPore™) |
|---|---|---|
| Intended Use | Matching the intended use of the predicate device: augmentation or restoration of bony contour in craniofacial defects. | StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects. (Matches predicate) |
| Material | Matching the material of the predicate device: Medical grade, HDPE (high density polyethylene). | Medical grade, HDPE (high density polyethylene). (Matches predicate) |
| Dimensions | The predicate device had patient-specific implants based on CT scans. The new device introduces "off-the-shelf" options. The criterion is that these off-the-shelf sizes are suitable for intra-operative cutting to achieve a fit for craniofacial defects. | Various shapes consisting of lengths 27mm - 80mm, widths 27mm - 110mm, and thicknesses/heights 1mm - 8mm to be further cut by prescribing surgeons intraoperatively to achieve best fit. (Difference from predicate, but deemed safe/effective through risk analysis). |
| Packaging | Similar packaging to ensure sterility and integrity. | Double steri-pouch and put in shelf box. (Similar to predicate's "Double peel pouched and put in a shelf box"). |
| Sterility | Same sterilization method as the predicate device. | Sterile, by Ethylene Oxide gas. (Matches predicate) |
| Safety Testing | Previous design validation and verification activities (material properties, sterilization, biocompatibility, shelf-life, stability) for the predicate (PoreStar™) are applicable. | A new risk analysis assessment for StarPore™ showed no new worst case introduced. All previous testing from PoreStar™ (now StarPore™) is applicable. No further performance testing was deemed needed. |
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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