The BioZorb SP 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 SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb SP Marker is provided sterile for single use and is implantable.

AI/ML Overview

The provided text is a 510(k) summary for the BioZorb SP Marker and a letter from the FDA determining substantial equivalence. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.

Here's what can be extracted and what is missing:

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

The document states:

Acceptance Criteria (Implied): "The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions." (This is a general statement, not specific criteria points).
Reported Device Performance: "Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence."

A specific table cannot be created from the given text as the detailed acceptance criteria and performance metrics are not listed. The document broadly indicates that the device met its intended performance based on imaging assessment and MR compatibility, which are considered sufficient to establish substantial equivalence to predicate devices.

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

This information is not provided in the document. The text mentions "performance data with regards to imaging assessment and MR compatibility," but gives no details about the studies' design, sample sizes, or data provenance.

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)

This information is not provided in the document. The document refers to "imaging assessment" but does not detail how ground truth was established or who assessed it.

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

This information is not provided in the document.

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

An MRMC study, particularly one involving AI, is not mentioned or implied in this document. The device is an implantable radiographic marker, not an AI diagnostic algorithm. Therefore, "human readers improve with AI vs without AI assistance" is not applicable in this context.

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

This is not applicable as the device is a physical implantable marker, not an AI algorithm.

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

This information is not explicitly stated. Given the device's nature (radiographic marker), the "imaging assessment" likely relied on visual confirmation by experts, but the exact method (e.g., expert consensus on image quality, visibility, or MR safety) is not detailed.

8. The sample size for the training set

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

In summary, the provided FDA document is for an implantable radiographic marker and focuses on demonstrating substantial equivalence to predicate devices based on its physical characteristics, indications for use, and general performance (imaging assessment and MR compatibility). It does not contain the detailed clinical study data, AI performance metrics, or reader study information typically associated with evaluating AI-powered diagnostic devices per your request.

Summary

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September 26, 2019

Focal Therapeutics Dhaval Saraiya Principal Regulatory Affairs Specialist 1010 Stewart Drive Sunnyvale, California 94085

Re: K192371

Trade/Device Name: BioZorb SP Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: August 29, 2019 Received: August 30, 2019

Dear Dhaval Saraiya:

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

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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 (OS) 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 mediation-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 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) K192371

Device Name BioZorb® SP Marker

Indications for Use (Describe)

The BioZorb SP Marker is indicated for radiographic marking of sites 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)

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510(k) SUMMARY

Date: August 29, 2019

I. SUBMITTER

Focal Therapeutics A Hologic Company 1010 Stewart Drive Sunnyvale, CA 94085

Contact person: Dhaval Saraiya Phone: 508.263.8823 Email: Dhaval.saraiya@hologic.com

II. DEVICE

Name of the device: BioZorb® SP Marker Common or usual name: Implantable Radiographic Marker Regulation name: Implantable Clip Regulation Number: 21 CFR 878.4300 Product Code: NEU Classification: Class II Panel: General and Plastic Surgery

III. PREDICATE DEVICE BioZorb Marker (K143484) BioZorb LP Marker (K152070) These cleared products have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE The BioZorb SP 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.

TECHNICAL CHARACTERISTICS

The BioZorb SP Marker has similar physical and technical characteristics as the predicate devices. The shape of the implant is identical to the current BioZorb (K143484) and the titanium clips (i.e. markers) are identical to those cleared in the BioZorb LP Marker (K152070).

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VI. PERFORMANCE DATA

All necessary testing has been performed for the subject BioZorb SP Marker to ensure substantial equivalence to the predicate device and demonstrate the device performs as intended.

Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence.

The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions.

VII. DETERMINATION OF SUBSTANTIAL EQUIVALENCE BASIS FOR The Indication/Intended Use and the fundamental scientific technology of the subject device have not been changed and are the same as those described in the predicate devices. The BioZorb SP Marker device is found to have a safety and effectiveness profile that is substantially equivalent to the predicate 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.