The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.

Device Description

The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called the "Pre-Formed Penile Silicone Block." The document describes the device, its intended use, and its equivalence to predicate devices, including summaries of non-clinical and clinical testing. However, it does not explicitly list acceptance criteria in a formal table or report specific performance metrics against such criteria in the way typically expected for an AI/ML device.

Here's an analysis based on the information provided, framed as closely as possible to your request, but with the understanding that this is a medical device submission, not an AI/ML algorithm submission. Therefore, many of your requested points, particularly those related to AI/ML specific studies (MRMC, standalone algorithm performance, training set details), are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds against specific performance metrics in a numbered or tabular format. Instead, it discusses the outcomes of a clinical study demonstrating the risks of the device and comparing them to existing similar devices.

Performance Metric	Reported Device Performance (N=100 patients)
Pain Assessment	Weighted average pain rating: 3.2 (on a 0-10 Comparative Pain Scale). Pain relief experienced on average in 7.2 days.
Erosion	3 cases observed (3% incidence). Occurred on average 8 months post-procedure (min 6 months, max 10 months). 3/3 cases linked to patient non-compliance.
Migration	4 cases observed (4% incidence). Occurred on average 1.5 months post-procedure (min 1 month, max 2 months). 3/4 cases linked to patient non-compliance.
Infection	3 cases observed (3% incidence). Occurred on average 3.5 months post-procedure (min 2.5 months, max 4.5 months).
Overall Risk	"Rates of pain, erosion, migration, and infection are low compared to reports of other silicone implants on the market." (Comparative statement, no specific threshold)

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

Sample Size: 100 patients
Data Provenance: Clinical evidence on 100 patients, without explicit mention of country of origin. The study is prospective, as follow-up data was collected after the surgical procedure at specified time points.

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

The ground truth in this context refers to the clinical outcomes and adverse events observed in patients. It's not explicitly stated how many "experts" established the ground truth in terms of retrospective review or consensus. The data appears to be collected clinically by the "clinic" observation and patient self-reporting (for pain). The "surgeon's discretion" is mentioned for contouring the device, implying a medical professional involved in the procedure itself.

4. Adjudication method for the test set

Not explicitly stated. Clinical observations and patient self-assessment (for pain) are the methods of data collection. It's not specified if multiple independent reviewers or an adjudication committee validated each reported adverse event. The document notes that a clinic observed the adverse events.

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 physical implant, not an AI/ML algorithm. Therefore, no MRMC study, human reader improvement with/without AI, or effect size related to AI assistance would be relevant or performed.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The ground truth is based on clinical outcomes and adverse events observed in patients following the surgical implantation of the device. This includes:

Patient-reported pain levels.
Clinically observed events such as erosion, migration, and infection.

8. The sample size for the training set

Not applicable. This not an AI/ML algorithm requiring a training set. The clinical study of 100 patients serves as the primary evidence for the device's safety and performance in humans.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 1, 2017

International Medical Devices, Inc. % Allison Komiyama Principal Consultant Acknowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104

Re: K162624

Trade/Device Name: Pre-Formed Penile Silicone Block Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: December 20, 2016 Received: December 22, 2016

Dear Allison Komiyama,

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162624

Device Name Pre-Formed Penile Silicone Block

Indications for Use (Describe)

The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary K162624

DATE PREPARED

January 27, 2016

MANUFACTURER AND 510(k) OWNER

International Medical Devices, Inc. 717 North Maple Drive, Beverly Hills, CA 90210, USA Telephone: (310) 652-2600 Fax: (310) 657-0500 Official Contact: James Elist, MD

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com

PROPRIETARY NAME OF SUBJECT DEVICE

Pre-Formed Penile Silicone Block

COMMON NAME Elastomer, Silicone Block

DEVICE CLASSIFICATION

21 CFR 874.3620, Product Code MIB, Class II

INDICATIONS FOR USE

The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.

DEVICE DESCRIPTION

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PREDICATE DEVICE IDENTIFICATION

The Pre-Formed Penile Silicone Block is substantially equivalent to the following predicates:

510(k)	Predicate Device Name / Manufacturer	Primary
Number		Predicate
K042380	Silicone Block / National Medical Devices, Inc.*	✓
K040042	Medisil Silicone Sheeting / Medisil Corporation
K022511	AART Calf Implant / Aesthetic and Reconstructive Technologies, Inc.
K021839	AART Gluteal Implant / Aesthetic and Reconstructive Technologies, Inc.

National Medical Devices, Inc. is now International Medical Devices, Inc.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Pre-Formed Penile Silicone Block. No additional non-clinical testing was provided in this submission in order to demonstrate substantial equivalence.

SUMMARY OF CLINICAL TESTING

Clinical evidence on 100 patients was collected to evaluate the risks of migration, erosion, and pain. After the surgical procedure, follow-up data for all patients was collected and evaluated at the following time points: the three successive days following the procedure, and at two weeks, one month, three months, six months, and twelve months following the procedure.

Pain was assessed post-operatively using a validated 0 to 10 Comparative Pain Scale. In 100 patients the weighted average pain rating across the patient population reviewed was 3.2. Pain relief was experienced on average in 7.2 days. In 100 patients there were 3 cases of erosion. This adverse event was observed by the clinic on average 8 months after the patient's procedure with a minimum of 6 months and a maximum of 10 months. In 100 patients there were 4 cases of migration. This adverse event was observed by the clinic on average 1.5 months after the patient's procedure with a minimum of 1 month and a maximum of 2 months. In 100 patients there were 3 cases of infection. This adverse event was observed by the clinic on average 3.5 months after the patient's procedure with a minimum of 2.5 months and a maximum of 4.5 months. 3 out of the 3 cases of erosion and 3 out of the 4 cases of migration were determined to be caused by failure of the patient to follow post-operative instructions (e.g., avoid use of external devices for the stretching/expansion of penile skin). Labeling to mitigate these risks has been added to the package insert in order to more directly address post-operative care.

IMD believes that the unique anatomy, physiology, and function of the penis does not increase the overall potential risks compared to the predicate devices. Clinical evidence demonstrates that rates of pain, erosion, migration, and infection are low compared to reports of other silicone implants on the market.

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EQUIVALENCE TO PREDICATE DEVICES

International Medical Devices, Inc. believes that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, has an equivalent intended use, and uses identical materials as the device cleared in K042380. The subject device has similar or identical technological characteristics to the devices cleared in K042380, K040042, K022511 and K021839.

CONCLUSION

The Pre-Formed Penile Silicone Block is considered substantially equivalent to the predicate devices based on the similar indications for use, clinical testing, and similar or identical technological characteristics. Based on this comparison, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices.

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.