The OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Device Description

The OSSIOfiber™ Hammertoe Fixation Systems\OSSIOfiber™ Hammertoe Fixation Implants include implants that have a ribbed design that is inserted between the proximal and middle phalanges, so the ribs fixate on the phalangeal canal of the toe. The OSSIOfiber™ Hammertoe fixation implants are made of OSSIOfiber " material which is degradable poly (L-lactide-co-D.L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber™ Hammertoe Fixation Implants are supplied sterile, pre-mounted on an implant inserter, offered in straight and 10-degree variations, and are available in several sizes: 16-21 mm long and 2.5-3.2 mm nominal diameter.

The OSSIOfiber™ Hammertoe Fixation System is a sterile kit which includes in addition to the implant pre-mounted on an inserter, a drill bit and a k-wire which are the instrumentations required for the procedure.

AI/ML Overview

The provided document is a 510(k) summary for the OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant. This document describes the device, its intended use, and the performance data used to demonstrate substantial equivalence to a predicate device.

Crucially, this document is NOT about an AI/ML-driven medical device. It's about a physical implant used for bone fixation. Therefore, most of the specific questions asked in the prompt, which are tailored for AI/ML device studies (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment, etc.), are not applicable to the content of this document.

However, I can extract the relevant information regarding acceptance criteria and performance as presented in this document for a physical medical device.

Acceptance Criteria and Device Performance (for a physical medical device)

The acceptance criteria for this non-AI/ML device are primarily demonstrated through mechanical testing and biocompatibility. The study's goal was to show substantial equivalence to a predicate device, meaning its performance metrics should be comparable or superior to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter/Test	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Mechanical Strength	Equivalent to or better than the predicate device (OSSIO™ Pin Product Family, K181180)	"Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation."
Biocompatibility	Material must be well-established or identical to predicate; additional testing (cytotoxicity, pyrogenicity) performed	"Material biocompatibility for the implants and instruments was primarily established by use of material identical to the predicate or use of well-established material. Additional testing of cytotoxicity and pyrogenicity (LAL) testing was performed on final, finished products."
Degradation Profile	Sufficient mechanical stability over 12-week healing period; substantial degradation within ~18 months	In vitro degradation testing: Weight loss, decrease in molecular weight, flexural strength, shear strength, and pullout testing performed over 12 weeks. "Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies."
Corrosion Resistance	Stainless steel instruments must meet relevant acceptance criteria	"Stainless steel instruments were tested for resistance to corrosion and met the relevant acceptance criteria."
MR Safety	Device must be safely used in an MRI environment	"A rationale was provided to support the MR safe labeling of the device."
Sterilization	Device must be supplied sterile	Device and predicate are supplied sterile and sterilized by EtO.

Since the prompt's specific questions are geared towards AI/ML device studies, and this document is for a physical implant, the following answers are either "Not Applicable" or infer what might be analogous in a non-AI context.

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 for Test Set: Not specified in terms of "samples" as it's a physical device being tested, not an algorithm. The testing involves flexural bending, shear, and pull-out tests on the implants. The number of samples for each mechanical test would typically be defined by engineering standards, but the exact count is not listed.
Data Provenance: The preclinical studies were conducted by Ossio Ltd., an Israeli company. The document does not specify if the studies were retrospective or prospective, as these terms are less relevant for mechanical and bench testing.

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

Not Applicable: This is a physical device, so "ground truth" isn't established by human experts in the way it is for AI image interpretation. Ground truth for mechanical properties is established by physical measurement against engineering standards.
The "experts" involved would be engineers and material scientists conducting the testing in a lab setting.

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

Not Applicable: Adjudication methods are relevant for human interpretation of data, particularly in AI studies where there might be disagreement on labels or classifications. For mechanical testing, no such adjudication is needed. Results are quantitative measurements.

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: MRMC studies are specific to AI-assisted human reader performance. This document concerns a physical implant.

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

Not Applicable: This is a physical implant; there is no algorithm for standalone performance.

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

Analogous Ground Truth: For this type of device, the "ground truth" for performance is based on established engineering standards and material science principles. For biocompatibility, it's based on ISO standards for biological evaluation of medical devices and comparison to well-characterized materials. For degradation, it's based on quantitative measurements of material properties over time in an in vitro environment. Comparison to the predicate device also acts as a benchmark.

8. The sample size for the training set

Not Applicable: This is a physical implant, not an AI model that requires a training set.

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

Not Applicable: No training set or AI model is involved.

Summary

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March 6, 2020

Ossio Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K190652

Trade/Device Name: OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: February 25, 2020 Received: February 25, 2020

Dear Janice Hogan:

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.

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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 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 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

Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K190652

Device Name

OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

OSSIOfiber™ Hammertoe Fixation System

Submitter

Ossio Ltd.

8 HaTochen Street, Caesarea, Israel, 3079861

Phone: +972-4-9986600 Facsimile: +972-4-9986601

Contact Person: Taly Lindner Date Prepared: March 13, 2019

Name of Device: OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant

Common or Usual Name: fixation, pin, smooth

Classification Name: Smooth or threaded metallic bone fixation fastener

Regulatory Class: Class II, 21 C.F.R. § 888.3040

Product Code: HTY

Primary Predicate Devices

OSSIO™ Pin Product Family (K181180)

Reference Devices

Arthrex PIP Dart (K141577)

Device Description

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Indications for Use

The OSSIOfiber™ Hammertoe Fixation System\OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Summary of Technological Characteristics

The OSSIOfiber 10 Hammertoe Fixation System has the same intended use, indications for use and material composition, and very similar design characteristic and principles of operation as the predicate device OSSIO™ Pin Product Family (K181180). The OSSIOfiber™ Hammertoe Fixation System's biocomposite material as well as the manufacturing techniques are the same as that of the cleared predicate. Both the device and the predicate are supplied sterile and are sterilized by EtC. Although there are differences in regards to shape and size as compared to the predicate, mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber™ Hammertoe Fixation System and its predicate device do not raise different questions of safety and effectiveness.

Performance Data

Mechanical testing of flexural bending, shear and pull-out was performed to verify the strength and fixation properties of the OSSIOfiber™ Hammertoe Fixation System, and to compare them to those of the predicate device. Testing was conducted initially and after in vitro degradation.

In vitro decradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over the 12week healing period. Testing included weight loss, decrease in molecular weight, flexural strength testing, shear strength testing, and pullout testing over 12 weeks.

Material biocompatibility for the implants and instruments was primarily established by use of material identical to the predicate or use of well-established material. Additional testing of cytotoxicity and pyrogenicity (LAL) testing was performed on final, finished products. A rationale was provided to support the MR safe labeling of the device.

Stainless steel instruments were tested for resistance to corrosion and met the relevant acceptance criteria.

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Conclusions

The OSSIOfiber™ Hammertoe Fixation System and OSSIOfiber™ Hammertoe Fixation Implant is substantially equivalent to its predicate device, OSSIO™ Pin Product Family (K181180). The OSSIOfiber™ Hammertoe Fixation Implant has the same intended uses, indications of use and material composition and similar technological characteristics and principles of operation as its predicate device. The minor differences do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Non-clinical testing data demonstrate that the OSSIOfiber™ Hammertoe Fixation System is substantially equivalent to the predicate device. Thus, the OSSIOfiber™ Hammertoe Fixation System is substantially equivalent.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.