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The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

This document is about the FDA 510(k) clearance for Implantech Associates Inc.'s Customized Contour Implant. It is a premarket notification, and as such, it does not typically contain detailed studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, the information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI/ML performance, human readers, sample sizes for test/training sets, and ground truth establishment, is not applicable to this document.

The document primarily focuses on:

• Device Description: A patient-matched device made of medical-grade silicone elastomer for augmentation, reconstructive, and cosmetic surgery (facial, gluteal, calf, pectoralis implants).
• Predicate Device Identification: Listing several previously cleared Implantech implants (K191130, K052504, K052505, K952708) with similar materials and intended uses.
• Non-Clinical Testing: The only "studies" mentioned are non-clinical tests to demonstrate safety based on industry standards, including:
  • Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
  • Packaging validation per ISO 11607
  • Shelf life validation with accelerated and real-time aging studies
  • Cytotoxicity testing per ISO 10993-5
  • 3D printer validation
• Conclusion: These non-clinical tests indicate that the device does not raise new issues of safety or effectiveness compared to the predicate device and is substantially equivalent.

No information is provided in the document regarding:

1. A table of acceptance criteria and reported device performance (in the context of clinical/AI performance): Not applicable for this type of device and submission.
2. Sample sizes used for the test set and data provenance: No clinical test set discussed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable; no ground truth establishment for AI performance.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done; this is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable; this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable; there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "Customized Contour Implant." This document primarily focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing.

Based on the provided text, there is no information related to acceptance criteria, a study proving device meets acceptance criteria, sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth used, sample size for training set, or how ground truth for training set was established, as these typically pertain to studies involving AI/ML-driven devices or clinical trials, which are not detailed here.

The document describes non-clinical testing for the Customized Contour Implant:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc., are provided, as this document focuses on non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This information is not provided in the context of the non-clinical tests performed.

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. This is not a study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
No MRMC study was done, nor is there any mention of AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests described, "ground truth" would relate to established standards or validated measurements. For example, for "3D printer validation," the ground truth would be the known dimensions of the predetermined shape (1 inch cube, 1 inch diameter sphere).

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Summary of Non-Clinical Testing Performed (as reported in the document):

The manufacturer conducted the following non-clinical tests to demonstrate safety based on current industry standards:

• Sterilization validation: Per ISO 17655-1 and ANSI/AAMI/ISO 20857.
• Packaging validation: Per ISO 11607.
• Shelf life validation: Included accelerated and real-time aging studies.
• Cytotoxicity testing: Per ISO 10993-5.
• Bacterial endotoxins testing: Per ANSI/AAMI ST72.
• 3D printer validation: The Fortus 360MC 3D Printer and its ancillary equipment were validated to accurately print a 3D image of a predetermined shape (1 inch cube, 1 inch diameter sphere) using STL file inputs. STL file creation using the VSP® software was validated prior to the 3D printer validation.

Conclusion: The results of these tests indicated that the Customized Contour Implant is substantially equivalent to the predicate device and does not raise different questions of safety or effectiveness.

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The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.

The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.

The provided text is a 510(k) Premarket Notification from the FDA regarding an ePTFE-Coated Auricular Implant. This document is a regulatory approval for a physical medical device (an implant for ear reconstruction), not a software or AI-based medical device.

Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, AUC) are not applicable to this document. The document describes:

1. Device Description: A silicone elastomer core with an ePTFE outer layer, shaped for external ear reconstruction.
2. Intended Use: Reconstruction of the external ear.
3. Predicate Devices: Other ear prostheses and facial implants, primarily based on material and design similarities, and identical indications for use.
4. Non-Clinical Testing:
   • Biocompatibility testing: In compliance with ISO 10993-1, covering cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, implantation, and chemical characterization.
   • Bond strength testing: To confirm the integrity of the silicone/ePTFE bond despite aging, repetitive sterilization, and pigment.
5. Conclusion: The device is substantially equivalent to predicate devices based on identical indications for use and similar technological characteristics, and material testing indicates it does not raise new issues of safety or efficacy.

There is no mention of a "study that proves the device meets the acceptance criteria" in terms of an AI/ML algorithm's performance on a test set, nor are there any acceptance criteria related to diagnostic accuracy, statistical metrics, or human reader performance. The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices through material testing and design comparison to ensure safety and effectiveness.

In summary, none of the requested information regarding AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies can be extracted from this document, as it pertains to a traditional physical medical implant, not an AI/ML diagnostic or assistive device.

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The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

The provided text is an FDA 510(k) clearance letter for the Implantech ePTFE Facial Implants. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

Therefore, I cannot provide the requested table and information based on the input text. The letter is a regulatory approval document, not a detailed study report.

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The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ePTFE Sheeting," which is a surgical mesh. This document grants market clearance based on substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or any of the other details you are asking for.

Therefore, I cannot provide the requested information based on this input. It's likely that such information would be found in the actual 510(k) submission document itself, not in the clearance letter.

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The Caff Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Calf Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Calf Implant (Silicone Carving Blocks)

The provided text is a 510(k) clearance letter from the FDA for a Gluteal Implant (later identified as a Calf Implant in the "Indications for Use" section). It confirms substantial equivalence to a predicate device.

However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting detailed performance study data against specific acceptance criteria in the format requested.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a detailed device specification.

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The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Gluteal Implants (Silicone Carving Blocks)

This document is a 510(k) premarket notification letter from the FDA regarding a Gluteal Implant. This type of document, particularly one from 2005, is highly unlikely to contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/ML-based medical devices.

The information provided is primarily an FDA clearance letter for a physical medical device (gluteal implant made of silicone) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested fields are not applicable.

Here's a breakdown based on the provided text, highlighting what is not applicable (N/A):

Summary of the Document's Actual Content:

The document is an FDA 510(k) clearance letter dated November 4, 2005, for a device named "Gluteal Implant" (Trade/Device Name) under the product code MIB (Ear, nose, and throat synthetic polymer material, although the device is for gluteal augmentation, the regulation number 21 CFR 874.3620 typically covers synthetic polymer materials used in ENT, implying a material-based classification rather than anatomical region).

• Indications for Use: The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. They are carvable to allow the surgeon to shape the device.
• Regulatory Status: The device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
• Applicant: Implantech Associates, Inc., submitted the 510(k) (K052504).
• Classification: Class II device.

The information you are seeking about acceptance criteria for an AI/ML device is not present in this physical device clearance letter.

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Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.

The provided 510(k) summary for the Implantech Associates Inc. "Gelzone" device does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study. This is a premarket notification where substantial equivalence to a predicate device is claimed, not a study demonstrating efficacy against defined metrics.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from this document as no such study is presented.

The summary states:

"Efficacy
Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information."

This indicates that the efficacy is primarily supported by the known properties of the silicone gel material and its prior use in substantially equivalent devices, rather than a new clinical study with specific acceptance criteria for the Gelzone product itself.

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Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.

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This document is an FDA 510(k) clearance letter for a medical device called "Conform Sheeting, Model IGEL." It is a regulatory document addressing the substantial equivalence of the device to legally marketed predicate devices.

This document DOES NOT contain information about acceptance criteria, device performance specifications, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

The letter is focused on the regulatory approval process and states that the device is substantially equivalent for its intended use, which is in the management and prevention of keloid and hypertrophic scars. It does not provide any technical performance data or a study description of the kind requested.

Therefore, I cannot fulfill the request using only the provided text.

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