The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

AI/ML Overview

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

The provided document is a 510(k) summary for a medical device (Temporary Fixation Pins), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way you've described.

Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness studies is not present in this type of document because such studies are generally not required for 510(k) clearances.

However, I can extract the relevant information and explain why other parts are missing based on the nature of a 510(k) submission.

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

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(Specific performance metrics and their acceptance thresholds are not provided as a separate study was not conducted.)	The document states: "The subject Temporary Fixation pins are manufactured from the same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device. Therefore, it is expected that they would perform equivalent to the predicate devices."

Explanation: In a 510(k) submission like this, the "acceptance criteria" for the device's performance are implicitly met by demonstrating substantial equivalence to a predicate device that has already established safety and effectiveness. No new, specific performance acceptance criteria are defined for this particular submission.

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 applicable. No performance study was conducted.
Data Provenance: Not applicable. No performance study was conducted.

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)

Number of Experts: Not applicable. No performance study was conducted.
Qualifications of Experts: Not applicable. No performance study was conducted.

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

Adjudication Method: Not applicable. No performance study was conducted.

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

MRMC Study: No. This is a physical medical device (fixation pins), not an AI/software device that would involve human readers or AI assistance.
Effect Size: Not applicable.

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

Standalone Study: No. This is not an algorithm or AI device.

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

Type of Ground Truth: Not applicable. No performance study was conducted in this 510(k) submission. The "ground truth" here is the prior FDA clearance of the predicate device, which established its safety and effectiveness.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. No AI/software device or training data set is involved.

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

Ground Truth Establishment for Training Set: Not applicable. No AI/software device or training data set is involved.

Summary of Device and Rationale from the Document:

Device: Eisertech, LLC Temporary Fixation Pins
Indications for Use: Guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), application as implant according to the principles of fracture management.
Predicate Device: aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire, Steinmann Pin (K131459)
Primary Argument for Substantial Equivalence: The subject device is substantially equivalent because it uses the "same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device." It also notes that the surface treatment is identical to a reference device (K190565).
Performance Testing: "Performance testing is not necessary and was not performed on the subject device" due to the substantial equivalence argument based on materials, geometry, dimensions, and intended use to the predicate.

In essence, this 510(k) submission is a regulatory filing arguing that the new device is sufficiently similar to an already-approved device that it does not raise new questions of safety or effectiveness, therefore eliminating the need for extensive new performance studies as would be required for a novel device or a PMA.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 26, 2019

EiserTech, LLC % Dawn Norman Executive Vice President MRC/X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119

Re: K192768

Trade/Device Name: Temporary Fixation Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW. HTY Dated: September 28, 2019 Received: September 30, 2019

Dear Dawn Norman:

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,

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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Indications for Use

510(k) Number (if known)

K192768

Device Name Temporary Fixation Pins

Indications for Use (Describe)

Eisertech, LLC Temporary Fixation Pins are indicated for the following:

guide wire for osteosynthesis implants
accessories for external fixation (Steinmann Pin)
application as implant according to the principles of fracture management

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

Temporary Fixation Pin September 28, 2019

Company:	Eistertech, LLC9988 Hibert Street Suite 302San Diego, CA 92131
EstablishmentRegistration:	3009381326
Primary Contact:	Dawn NormanPhone: 618-604-3064
Company Contact:	Lukas EisermannPhone: 888-262-2817
Trade Name:	Temporary Fixation Pin
Common Name:	Pin, Fixation, SmoothPin, Fixation, Threaded
Classification:	Class II
Regulation Number:	21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
Panel:	87- Orthopedic
Product Code:	JDW, HTY
PrimaryPredicate Device:	aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire,Steinmann Pin (K131459)
ReferencePredicate Device:	Eisertech, LLC Cervical Plate System Instruments (K190565)

Device Description:

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Indications for Use:

Eisertech, LLC Temporary Fixation Pins are indicated for the following:

guide wire for osteosynthesis implants
accessories for external fixation (Steinmann Pin)
application as implant according to the principles of fracture management

Substantial Equivalence:

The subject Eisertech, LLC Temporary Fixation Pin is substantially equivalent to predicate aap Implantate AG's aap Wire Bone / K-Wire; Cerclage Wire, Steinmann Pin (K131459, S.E. 10/17/2013) with the surface treatment being identical to the surface treatment cleared for use in instruments in reference device Eisertech, LLC's Cervical Plate System Instruments (K190565, S.E. 05/31/2019).

The Indications for Use, Materials, and Geometry for predicate devices are all similar to those of the subject device. The surface treatment is identical to the surface treatment applied to the reference device Eisertech, LLC Cervical Plate Instruments.

Performance Testing:

The subject Temporary Fixation pins are manufactured from the same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device. Therefore, it is expected that they would perform equivalent to the predicate devices. Thus, performance testing is not necessary and was not performed on the subject device.

Conclusion:

There are no substantial differences between the Temporary Fixation Pins and the predicate device with respect to intended use and technological characteristics, including basic design, base materials of manufacture, mechanical properties, and intended effect.

Therefore, the Temporary Fixation Pins can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.

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.