BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

AI/ML Overview

The provided text is a 510(k) Summary for the BioSiCar Silicone Implant. This document describes the device and its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical testing. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The "acceptance criteria" discussed in the document are general requirements for the device's safety and performance related to its physical and biological properties, not performance metrics for an AI/ML algorithm.

Therefore, I cannot provide accurate answers to most of the requested points, as they pertain to AI/ML device validation studies.

However, I can extract the information that is present:

Metalware Technology Corp. BioSiCar Silicone Implant - 510(k) Summary Analysis

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

The document mentions that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use". However, it does not explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values. It only states that the device "meets the requirements".

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met requirements
Performance & Shelf life	Met requirements
Sterilization verification	Met requirements

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

Not applicable. The tests performed are non-clinical (e.g., material testing, sterilization, shelf-life), not a clinical study with a "test set" of patient data in the context of an AI/ML device.

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

Not applicable. This information is relevant for AI/ML validation where expert review establishes ground truth for image or data interpretation. The BioSiCar Silicone Implant is a physical implant.

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

Not applicable. This is for AI/ML performance evaluation.

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. This device is a physical implant, not an AI/ML-driven diagnostic or assistive tool.

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

No. This device is a physical implant.

7. The type of ground truth used

For biocompatibility, performance, and sterilization, the "ground truth" would be established by industry standards (e.g., ISO standards for biocompatibility) and regulatory requirements, rather than expert consensus on medical images or pathology in the context of AI/ML.

8. The sample size for the training set

Not applicable. This is for AI/ML model training.

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

Not applicable. This is for AI/ML model training.

Summary of what the document does provide:

The document describes the BioSiCar Silicone Implant as "intended for the augmentation or reconstruction of the nasal and/or chin contour." It confirms that "BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use."

It states that non-clinical testing was conducted, including:

Biocompatibility
Performance & Shelf life
Sterilization verification

The conclusion drawn from this non-clinical testing is that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device."

Crucially, "No clinical test data was used to support the decision of substantial equivalence," and the substantial equivalence determination is based on the device having "similar intended use, same technology/mechanism of action, same claim of safety and performance, and similar technological specification as the predicate device, SOFTXIL (K171851)." This implies the acceptance criteria for this type of medical device are primarily focused on material properties, biocompatibility, and manufacturing processes, rather than diagnostic accuracy or clinical outcomes demonstrated in patient studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 20, 2020

Metalware Technology Corp. Megan Chang Product Manager 10F, No. 117, Minquan Rd., Xindian Dist. New Taipei City, 231 Tw

Re: K193392

Trade/Device Name: BioSiCar Silicone Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: June 19, 2020 Received: June 22, 2020

Dear Megan Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193392

Device Name BioSiCar Silicone Implant

Indications for Use (Describe)

BioSiCar Silicone Implant is intended for the augmentation of the nasal and/or chin contour.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

5.1 Type of Submission:	Traditional
5.2 Date of Summary:	11/26/2019
5.3 Submitter:	Metalware Technology Corp.
Address:	10F, No.117, Minquan Rd., Xindian Dist., NewTaipei City, 231, Taiwan (R.O.C.)
Phone:	+886-2-8667-2878
Fax:	+886-2-8667-3686
Contact:	Megan Chang(megan.chang@metalware.com.tw)

5.4 Identification of the Device:

Proprietary/Trade name:	BioSiCar Silicone Implant
Classification Product Code:
Primary Product code:	MIB
Additional Product code:	LZK, FWP
Regulation Number:	874.3620
Regulation Description:	Ear, nose, and throat synthetic polymer material.
Review Panel:	General & Plastic Surgery
Device Class:	II

5.5 Identification of the Predicate Device:

Predicate Device Name:	SOFTXIL
Manufacturer:	Bistool
Classification Product Code:	MIB, LZK, FWP
Regulation number:	874.3620
Device Class:	II
510(k) Number:	K171851

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5.6 Indications for Use / Intended Use of the Device

BioSiCar Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.

5.7 Device Description

5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, BioSiCar Silicone Implant:

. Biocompatibility
. Performance & Shelf life
Sterilization verification

All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

5.9 Clinical and Usability Testing

No clinical test data was used to support the decision of substantial equivalence.

5.10 Substantial Equivalence Determination

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The subject device has similar intended use, same technology/mechanism of action, same claim of safety and performance, and similar technological specification as the predicate device, SOFTXIL (K171851). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

Item	Subject device	Predicate device	Substantial equivalence determination
Manufacturer	Metalware Technology Corp.	BISTOOL
Trade Name	BioSiCar Silicone Implant	SOFTXIL
510(k) No.	(to be assigned)	K171851
Product Code	MIB, LZK, FWP	MIB, LZK, FWP	Same
RegulationNumber	874.3620	874.3620	Same
Intended UseIndications forUse	BioSiCar Silicone Implant isintended for the augmentationor reconstruction of the nasaland/ or chin contour.	SOFTXIL is intended for theaugmentation or reconstructionof the nasal, malar, and or chincontour.	SimilarSubject device is for nasaland/ or chin contour,while the predicate devicehas a wider usage thatincludes nasal, chin, andmalar.
Material	Silicone elastomer	Silicone elastomer	Same
Design	Offers two major shapes tomeet the needs in nasal andchin locations.	Offers various shapes to meetthe needs in differentlocations.	Same
Function	Augmentation/ Reconstructionof the nasal and/or chincontour.	Augmentation of the nasal,malar, and or chin contour.	SimilarSubject device is for nasaland or chin contour, whilethe predicate device has awider usage that includesnasal, chin, and malar.

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Size	Provided in various sizes(Please see Section 11 fordetailed sizes). Can be carvedor cut by the physician to fiteach patient.	Provided in various sizes. Canbe carved or cut by thephysician to fit each patient.	Same
Usage	For single use only	For single use only	Same
Sterile	Yes	Yes	Same

5.11 Similarity and Difference

The BioSiCar Silicone Implant has been compared with "SOFTXIL". The subject device has similar intended use, same technology/mechanism of action, same safety and performance, and similar technological specification as the predicate device. Although there are some different specifications between these devices, the performance test was completed and demonstrated similar test results (please refer to Section 18). The subject device has also undergone safety and performance tests, and the results complied with the test requests (referring to Section 14 and 15). Therefore, the differences between the subject device and the predicate device do not raise any new issue of substantial equivalence.

5.12 Conclusion

In conclusion, Metalware Technology Corp. believes that BioSiCar Silicone Implant maintains the same safety and effectiveness, and thus, is substantially equivalent to the predicate device.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.