The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.

Device Description

The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation.

All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized.

AI/ML Overview

This document appears to be a 510(k) Pre-market Notification for a medical device (Tactra™ Penile Prosthesis), not a study report detailing acceptance criteria and performance of a device based on clinical data or AI algorithm performance.

Therefore, many of the requested items related to "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. Specifically, there is no information regarding:

A table of acceptance criteria and reported device performance (in the context of clinical benchmarks or AI algorithm metrics).
Sample sizes for test sets, data provenance, or details about training sets.
Number/qualifications of experts, adjudication methods, or ground truth establishment for a study related to acceptance criteria.
MRMC comparative effectiveness studies or standalone algorithm performance.

This document describes the device, its intended use, and its substantial equivalence to predicate devices based on bench testing and biocompatibility testing. It explicitly states: "The Tactra Penile Prosthesis incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices... To demonstrate substantial equivalence... technological characteristics and performance criteria were evaluated using bench testing, and biocompatibility testing. The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices."

As such, I cannot provide the requested information that typically comes from a performance study or clinical trial report.

However, I can extract the following relevant information from the provided text:

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

Acceptance Criteria (Implied by Substantial Equivalence): The device's technological characteristics and performance (as evaluated by bench and biocompatibility testing) must not raise new questions of safety and effectiveness compared to the predicate devices (AMS Spectra™ Concealable Penile Prosthesis and Mentor (Coloplast) Genesis™).
Reported Device Performance: "The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices."

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/Not provided: This document describes bench and biocompatibility testing, not human clinical trials or AI algorithm testing with specific test sets in the traditional sense. Therefore, there are no details on sample size, data provenance, or study design types (e.g., retrospective/prospective).

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/Not provided: Ground truth establishment by experts is relevant for studies involving subjective human interpretation (e.g., medical imaging AI). This document details device engineering and material science testing, not interpretative tasks.

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

Not applicable/Not provided: Not relevant for the type of testing described.

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 penile prosthesis, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.

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

No: This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in the context of an AI study: The "truth" or reference standard for bench and biocompatibility testing would be established industry standards, specifications, and regulatory requirements for material properties, mechanical performance (e.g., rigidity, malleability, durability), and biological response. No details on specific "ground truth" establishment methods are provided beyond "bench testing, and biocompatibility testing."

8. The sample size for the training set

Not applicable/Not provided: No training set mentioned as this is not an AI/machine learning submission.

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

Not applicable/Not provided: No training set or associated ground truth discussed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a dark blue color. The words "Boston Scientific" are stacked on top of each other, with "Boston" on the top line and "Scientific" on the bottom line.

Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 508-683-4000 www.bostonscientific.com

510(k) Summary

Submitter	Boston Scientific Corporation
	10700 Bren Road West
	Minnetonka, MN 55343
	USA
	Phone: 952-930-6252
	Contact Person: Laura Kelly
	Date Prepared: December 21, 2018
Device:	Name of Device: Tactra™ Penile Prosthesis
	Common or Usual Name: Malleable Penile Prosthesis
	Classification Name: Penile Rigidity Implant (per 21 CFR 876.3630)
	Regulatory Class: II (Special Controls)
	Product Code: FAE
Predicate Device	AMS Spectra™ Concealable Penile Prosthesis (K090663)
	Mentor (Coloplast) Genesis™ (K040959)
	No reference devices were used for this submission.
Device Description	The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
	The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation.
	All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized.

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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 508-683-4000

www.bostonscientific.com

Configuration	Outer Diameter	Working Length	RTE Offering
1	9.5 mm	14 - 23 cm	0 cm, +0.5 cm, +1 cm
2	11 mm	16 - 25 cm	0 cm, +0.5 cm, +1 cm
3	13 mm	18 - 27 cm	0 cm, +0.5 cm, +1 cm
Indications for Use	The TactraTM device is designed to provide penile rigidity and malleability, and the device can be placed in either an erect or a concealed position.The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	The Tactra Penile Prosthesis incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices, AMS Spectra Concealable Penile Prosthesis (K090663) and the Mentor (Coloplast) Genesis (K040959).
Performance Data	To demonstrate substantial equivalence of the Tactra Penile Prosthesis to the predicate devices, technological characteristics and performance criteria were evaluated using bench testing, and biocompatibility testing.The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices.
Conclusion	As the intended use and fundamental scientific technology have not changed, non-clinical data supports a determination that there are no new questions of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate devices, and that it is at least as safe and effective for its intended use.

The Tactra Penile Prosthesis will be available in the following configurations:

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Image /page/2/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 16, 2019

Boston Scientific Corporation Laura Kelly Regulatory Affairs Specialist II 10700 Bren Road West Minnetonka, MN 55343

Re: K183619

Trade/Device Name: Tactra™ Penile Prosthesis Regulation Number: 21 CFR§ 876.3630 Regulation Name: Penile Rigidity Implant Regulatory Class: II Product Code: FAE Dated: March 13, 2019 Received: March 14, 2019

Dear Laura Kelly:

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for 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)

K183619

Device Name

TactraTM Penile Prosthesis

Indications for Use (Describe)

The Tactra™ device is designed to provide penile rigidity and the device can be placed in either an erect or a concealed position.

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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Regulation Number and Section

§ 876.3630 Penile rigidity implant.

(a)
Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”