The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

AI/ML Overview

The provided text is a 510(k) summary for the BRM Extremities NewPrim System, a toe joint polymer constrained prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

The document does not contain information about a clinical study with acceptance criteria, human readers, or ground truth for evaluating the device's performance in the context of diagnostic accuracy or clinical outcomes. Instead, it describes bench testing conducted to support substantial equivalence.

Therefore, many of your requested points cannot be answered based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document mentions two types of bench testing:

Test Type	Acceptance Criteria	Reported Device Performance
Static Tensile Testing	The subject device should demonstrate static strength substantially equivalent to the reference predicate (K023562).	"Static tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562)." (Specific numerical values for acceptance or performance are not provided in this summary, but the conclusion of substantial equivalence is stated.)
Fatigue Testing	The NewPrim spacer should perform as intended in fatigue displacements more extreme than expected with physiologic implant displacement.	"Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement." (Again, specific numerical values for acceptance or performance are not provided, but the conclusion of proper performance is stated.)
LAL Testing	Compliance with LAL testing requirements for orthopedic devices per AAMI ST-72.	"Additionally, the NewPrim System is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing." (Demonstrates compliance with a safety standard for endotoxins.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the bench tests.
Data Provenance: This is bench testing, not clinical data from patients. The manufacturer is BRM Extremities, located in Milano, Italy.

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

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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 prosthesis, not an AI diagnostic tool.

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

Not applicable. This device is a prosthesis, not an AI diagnostic tool.

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

For the bench tests, the "ground truth" would be the predefined engineering specifications and comparison to the predicate device's measured performance for mechanical characteristics and compliance with a standard for LAL testing. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary

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February 13, 2020

BRM Extremities % Margeaux Rogers Associate Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K191966

Trade/Device Name: NewPrim System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe Joint Polymer Constrained Prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 16, 2020 Received: January 16, 2020

Dear Margeaux Rogers:

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

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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 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,

For Ting Song, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Device Name BRM Extremities NewPrim System

Indications for Use (Describe)

The BRM Extremities NewPrim device is intended for use in:

Hallux rigidus or hallux limitus;
Painful rheumatoid arthritis;
Hallux abducto valgus associated with arthritis;
Unstable or painful joint from previous surgery

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Manufacturer:	BRM Extremities
	Via Ciro Menotti 10
	20129 Milano, Italy
Contact:	Ing. Andrea De Maglio
	Regulatory Affairs Manager
	BRM Extremities Srl
	Tel. 02.36735123
	Cell. 389.1938034
	Email. A.demaglio@brm-extremities.com
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC
	1050 K Street, NW, Suite 1000
	Washington, DC 20001
	Phone: 202.552.5800
Date Prepared:	February 12, 2020
Device Trade Name:	BRM Extremities NewPrim System
Device Common Name:	Toe joint polymer constrained prosthesis
Classification:	21 CFR 888.3720 – Prosthesis, Toe, Constrained Polymer
	Class II
Product Codes:	KWH

Indications for Use:

The BRM Extremities NewPrim device is intended for use in:

Hallux rigidus or hallux limitus; -
Painful rheumatoid arthritis; -
Hallux abducto valgus associated with arthritis; -
Unstable or painful joint from previous surgery -

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Device Description:

Predicate Devices:

The NewPrim system is substantially equivalent to the primary predicate RTS Flexible 1st MPJ Implant w/ Grommets (K153609) and reference predicate Integra Classic Great Toe Implant (K023562).

Substantial Equivalence:

The NewPrim System and the legally marketed predicate device have the same intended use and indications for use, similar dimensions, geometry and materials. The stems of the devices are fit into the intramedullary canals of the first metatarsal joint. The devices are constrained and made of silicone elastomer. The devices also have proximal and distal grommets that may be used with the silicone implant.

Static tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562). Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement. Additionally, the NewPrim System is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing.

Regulation Number and Section

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.