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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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(155 days)
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.
This document is a 510(k) premarket notification for the MEDPOR® Fixation System - Cranial. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria. In the context of a 510(k) submission for a device like plates and screws, the "acceptance criteria" are generally related to demonstrating that the new device is as safe and effective as existing legally marketed devices (predicate devices) and that any differences do not raise new questions of safety or effectiveness.
Therefore, the requested information elements (1-9) which typically relate to performance studies for novel or significantly modified devices, are not explicitly provided in this 510(k) summary. A 510(k) does not usually include a formal "study" with stated acceptance criteria and device performance results in the same way a PMA or de novo submission might. Instead, it relies on comparisons to predicate devices and adherence to established material standards and manufacturing practices.
Here's a breakdown of what can be extracted and what is not applicable or stated:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific performance study in this 510(k) summary. The acceptance criteria for a 510(k) is generally the demonstration of "substantial equivalence" to predicate devices, meaning the new device has "similar technological characteristics" and "same intended use."
- Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life, etc.) are reported with numerical values in this summary. The submission implies that the material and design choices (titanium, specific alloys) meet established standards (ASTM F67, ASTM F136), which are themselves forms of performance criteria.
2. Sample size used for the test set and the data provenance
- Not applicable as no specific device performance testing study with a "test set" and "data provenance" is detailed in this 510(k) summary. The comparison is primarily against the characteristics of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as there is no "test set" ground truth established by experts in the context of this 510(k) summary. Substantial equivalence is assessed by regulatory reviewers based on design, materials, and intended use.
4. Adjudication method for the test set
- Not applicable for the same reasons as #3.
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 is a medical device for surgical fixation, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device for surgical fixation, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a 510(k) submission for this type of device is the evidence that the device's technological characteristics (materials, design, sterilization) and intended use are substantially equivalent to legally marketed predicate devices, which are themselves considered safe and effective. The reference to conformity with ASTM standards (F67 and F136) serves as a form of "ground truth" for material properties.
8. The sample size for the training set
- Not applicable as there is no "training set" in the context of this 510(k) submission. Design and manufacturing are based on established engineering principles and material standards.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as #8.
Summary based on the provided document:
The provided document is a 510(k) Summary. For devices like the MEDPOR® Fixation System - Cranial, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to predicate devices already on the market. The "study" proving this largely involves a comparison of technological characteristics (materials, design, indications for use, sterilization) and adherence to recognized standards.
Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Features:
| Criteria Category (Implied) | Acceptance Criteria (How substantial equivalence is demonstrated) | Reported Device Features / Performance |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices. | "Intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton." (Compared to predicate intended uses which include cranial, craniofacial, and reconstructive procedures of the craniofacial skeleton). |
| Device Classification | Must align with predicate devices or existing classifications. | Class II, Code HBW, Reg. No. 882.5360 - Cranioplasty plate fastener (Matches or is consistent with classifications of predicate devices). |
| Materials | Must be substantially equivalent to predicate devices, preferably with a history of safe use, and adhere to recognized standards. | Plates: CP Grade 4 Titanium (Adheres to ASTM F67 Standard). Screws: 6-4 ELI Titanium Alloy (Meets ASTM F136 standard). (Comparable to titanium/titanium alloy used in multiple predicate devices, though one predicate uses bioabsorbable material). |
| Design | Must be substantially equivalent in form and function (e.g., plates and screws for fixation). | Plate and screw system. (Exhibited by all predicate devices). Includes color anodization for ease of use. |
| Sterilization | Must use appropriate and validated sterilization methods. | Ethylene Oxide & Steam sterilization. (Comparable to predicate devices which use steam, or are supplied sterile/non-sterile with instructions for steam sterilization). |
| Instrumentation | Presence of dedicated instrumentation. | Yes. (Comparable to most predicate devices). |
Explanation of Study (Substantial Equivalence Demonstration):
The "study" in this context is the detailed comparison provided in the "Substantial Equivalence" section and the comparative table on page 2 of the document. This comparison directly addresses how the MEDPOR Fixation System - Cranial aligns with the identified predicate devices:
- Comparison of Intended Use: The document argues that the intended use of the MEDPOR system (fixating cranial implants to the cranial skeleton) is comparable to the broad craniofacial, cranial, and reconstructive procedures of the predicate devices.
- Comparison of Materials: The use of specific titanium grades (CP 4 Titanium for plates, 6-4 ELI Titanium Alloy for screws) is stated to meet ASTM standards F67 and F136, respectively. The document highlights that titanium has a "long history of use in surgical implantable products" and that these materials are consistent with most predicate devices (Predicate Device #1 is an exception, being bioabsorbable).
- Comparison of Technological Characteristics: The document states that the "technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness." This includes design as a plate and screw system, dedicated instrumentation, and sterilization methods.
Missing/Not Applicable Information:
- Sample Size for Test Set/Training Set: Not applicable for a 510(k) based on substantial equivalence comparison of device characteristics.
- Data Provenance: Not applicable.
- Experts/Ground Truth for Test/Training set: Not applicable in the sense of clinical study experts. The "ground truth" hinges on the established safety and effectiveness of the predicate devices and conformity to recognized standards.
- Adjudication Method: Not applicable.
- MRMC or Standalone AI Study: Not applicable as this is not an AI/diagnostic device.
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(336 days)
The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
The provided document is a 510(k) summary for the MEDPOR® CONTAIN™ Implant. It describes the device, its intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.
Crucially, this document is a premarket notification for a medical device and does not contain a study or data proving the device meets acceptance criteria. Instead, it is a submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness.
Therefore, many of the requested sections, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, and details of comparative effectiveness studies (MRMC or standalone), cannot be extracted from this document, as they are not present.
However, I can provide information based on what is available regarding the comparison to predicate devices, which is the basis for its clearance.
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the typical sense of a performance study with numerical targets and results. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, material, design, sterilization, and biocompatibility.
The "reported device performance" in this context is implicitly the assertion that the MEDPOR CONTAIN Implant performs similarly to its predicates due to shared characteristics.
| Category | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as described in the document) |
|---|---|---|
| Intended Use | Stabilize, support, and provide space maintenance for bone graft materials in maxilla, mandible, and zygoma. | The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma. (Matches predicate intended uses or sufficiently similar) |
| Material | Biocompatible, linear, high-density polyethylene. | A linear, high-density polyethylene biomaterial. (Same as Predicate #1) |
| Design/Form | Sheets of various sizes and thicknesses; trimmable/cuttable. | 15mm x 30mm, 25mm x 30mm, 45mm x 30mm sheets in 0.25mm and 0.35mm thicknesses and other shapes and sizes, as well as patient specific customized shapes. Can be trimmed or cut to size and bent. (Similar to predicate forms) |
| Sterility | Sterile | Sterile |
| Sterilization Method | Appropriate and effective sterilization method. | EtO (Same as Predicate #1) |
| Biocompatibility | Biocompatible | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) premarket notification based on substantial equivalence to existing predicate devices, not a clinical study report with a test set. There are no "test sets" or "data provenance" details for a performance study in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no performance study with a test set is reported, there is no "ground truth" established by experts within this document. The assessment is regulatory by the FDA based on the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or performance data is presented, so no adjudication method is relevant here.
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. A MRMC comparative effectiveness study is not discussed. This device is a passive implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not an algorithm, so this type of study is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth data from a performance study is utilized in this 510(k) summary. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which the new device is compared.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, there is no associated ground truth establishment method.
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