The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Device Description

The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium). The BioZorb Marker is provided sterile for single use and is implantable.

AI/ML Overview

The provided document is a 510(k) summary for the BioZorb Marker, which is an implantable radiographic marker. The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way that an AI/ML device would be evaluated for clinical performance metrics like sensitivity, specificity, accuracy, etc.

Instead, this 510(k) pertains to a physical medical device (an implantable marker) and focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and certain performance tests related to safety and physical properties.

Therefore, many of the requested elements (like "acceptance criteria for clinical performance", "sample size for test set", "number of experts for ground truth", "MRMC study", "standalone performance", "training set sample size") are not applicable to the type of device and study described in this 510(k) summary.

However, I can extract the information that is present and indicate where information is not applicable or not provided.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Device Performance for BioZorb Marker

Given that this is a 510(k) for an implantable radiographic marker (a physical device), the "acceptance criteria" and "device performance" are primarily focused on physical and material properties, sterilization, and biocompatibility, rather than clinical efficacy metrics associated with AI/ML devices. The "performance data" listed below serves as the basis for demonstrating that the device is safe and performs as intended, and crucially, is substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Test	Acceptance Criteria (Implied by standard conformance)	Reported Device Performance (as stated in document)
Physical/Material Properties
Overall Technological Characteristics	Radiographically visible permanent marker	SAME as predicate (radiographically visible permanent marker element(s) in bioabsorbable polymer spacer)
Principle of Operation	Marker positioned into tissue for radiographic visualization	SAME as predicate (Marker is positioned into tissue site for radiographic visualization of tissue site)
Visualization Compatibility	Mammography, Ultrasound, X-Ray, CT compatible	SAME as predicate (Mammography, Ultrasound, X-Ray, CT)
Materials of Construction	Titanium, bioabsorbable polymer	SAME as predicate (Titanium, bioabsorbable polymer (spacer))
Overall Device Length	2-5 cm	SAME as predicate (2-5 cm)
Typical Anatomical Treatment Site	Soft tissue including breast	SAME as predicate (Soft tissue including breast)
Method of Marker Deployment	Manual, open surgical	SAME as predicate (Manual, open surgical)
Marker Stability	Sutured in place	SAME as predicate (Sutured in place)
Safety & Sterilization
Pyrogenicity (USP Pharmacopeia <85>)	Conformance to USP <85>	Performance data included.
Sterility (Provided sterile)	Yes	Yes
Sterilization Method	Radiation	SAME as predicate (Radiation)
Biocompatibility
MR Compatibility (ASTM 2052-14, ASTM F2213-06, ASTM 2182-11a, ASTM F2119-07)	Conformance to relevant ASTM standards	Performance data included.
Shelf Life
Shelf life testing (ASTM D4169, ASTM F2096, ASTM F88/F88M, ASTM F1980, ISO 11607-1)	Conformance to relevant ASTM/ISO standards within specified shelf life	Performance data included.

Summary Statement: The document states, "The Focal BioZorb Marker performance is identical to the predicate device (K113202)." This is the primary "proof" of meeting performance expectations, by demonstrating substantial equivalence to an already marketed device.

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 / Not Provided: The document describes performance data related to physical and material testing (pyrogenicity, MR compatibility, shelf life) and states the device performance is "identical to the predicate device (K113202)". It does not discuss a "test set" in the context of clinical data or AI/ML model validation with a specific sample size of patients/cases, nor does it specify data provenance in terms of country or retrospective/prospective collection for clinical evaluation.

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 information is relevant for studies validating diagnostic or predictive AI/ML models. For a physical implantable marker, ground truth for clinical performance in this context is not established by expert review of images, but rather by the physical and biological performance of the device itself (e.g., its visibility on imaging, biocompatibility, resorption rate).

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

Not Applicable: Adjudication methods are used to establish a consensus ground truth in reader variability studies, which is not described for this device.

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 is a submission for a physical implantable marker, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described.

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

Not Applicable: This is not an algorithm or AI device.

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

For the performance data listed (pyrogenicity, MR compatibility, shelf life), the "ground truth" implicitly relies on validated standard testing methodologies (e.g., USP Pharmacopeia, ASTM, ISO standards) that define acceptable parameters for these physical and biological characteristics. For the primary claim of substantial equivalence, the "ground truth" is the performance of the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable: There is no AI/ML model for which a training set would be used.

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

Not Applicable: There is no AI/ML model for which a training set ground truth would be established.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle with three human profiles incorporated into its design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem.

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

June 29, 2015

Focal Therapeutics Mr. George Hermann Official Correspondent 4370 Alpine Road, #101 Portola Valley, California 94028

Re: K143484

Trade/Device Name: BioZorb Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: May 22, 2015 Received: May 28, 2015

Dear Mr. Hermann:

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

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device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K143484

Device Name BioZorb Marker

Indications for Use (Describe) The BioZorb Marker is indicated for radiographic marking of sites in soft tissue.

In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

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)

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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6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Focal Therapeutics
DATE PREPARED:	June 23, 2015
CONTACT PERSON:	George HermannFocal Therapeutics4370 Alpine Rd. #101Portola Valley, CA 94028Phone: 650.530.2394Fax: 650.530.2397
TRADE NAME:	BioZorb Marker
COMMON NAME:	Implantable Radiographic Marker
CLASSIFICATION NAME:	Implantable Clip, 21 CFR, 878.4300, 892.5050
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE	NEU
PREDICATE DEVICES:	Mixed Media Marker (K102506)Civco Suture-type Marker [reference predicate] (K071614)Focal Therapeutics BioZorb Tissue Marker (K113202)

Substantially Equivalent To:

The BioZorb Marker is substantially equivalent in intended use, principal of operation and technological characteristics to the Mixed Media Marker (K 102506), Suture-type Marker (K071614) and the BioZorb Tissue Marker (K113202).

Description of the Device Subject to Premarket Notification:

The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium).

The BioZorb Marker is provided sterile for single use and is implantable.

Indication for Use:

The BioZorb Marker is indicated for radiographic marking of sites in soft tissue.

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In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Technical Characteristics:

The BioZorb Marker has similar physical and technical characteristics to the predicate devices, as illustrated in the table below.

	Subject device	Primary	Primary	Reference
		Predicate	Predicate	Predicate
	Focal	Focal	Cortex	Civco Medical
	BioZorb	BioZorb	Mixed Media	Suture-type
	Marker	Tissue	Marker	Marker
		Marker	(K102506)	(K071614)
		(K113202)
Overall	Radiographically	SAME	Radiographically	SAME
Technological	visible		visible
Characteristics	permanent		permanent
	marker		marker
	element(s) in		element(s) with
	bioabsorbable		or without
	polymer spacer		polymer
Principle of	Marker is	SAME	SAME	SAME
Operation	positioned into
	tissue site for
	radiographic
	visualization of
	tissue site
Visualization	Mammography	SAME	SAME	X-Ray
Compatibility	Ultrasound			CT
	X-Ray			(presumed)
	CT
Materials of	Titanium,	SAME	Gold, titanium or	Gold.
Construction	bioabsorbable		PEEK polymer,	bioabsorbable
	polymer		stainless steel	polymer
	(spacer)			(suture)
Overall Device	2-5 cm	SAME	1 mm x ~ 20 mm	>5 cm (with
Length				suture)
Typical	Soft tissue
Anatomical	including breast	SAME	SAME	breast
Treatment Site
Method of	Manual,	SAME	Manual,	SAME
Marker	open surgical		percutaneous
Deployment
Marker	Sutured in place	Tissue	Tissue retention	SAME
Stability		retention
Provided sterile	Yes	Yes	Yes	Yes
Steriliz. method	Radiation	SAME	Unknown	Unknown

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Performance Data:

Performance data included:

Pyrogenicity, LAL (USP Pharmacopeia <85>) .
MR compatibility (ASTM 2052-14, ASTM F2213-06, ASTM 2182-11a, . ASTM F2119-07) and,
Shelf life testing (ASTM D4169, ASTM F2096, ASTM F88/F88M, . ASTM F1980, ISO 11607-1).

The Focal BioZorb Marker performance is identical to the predicate device (K113202).

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioZorb Marker is determined by Focal Therapeutics to be substantially equivalent to existing legally marketed devices.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.