The Precision Screw is intended for establishing fixed reference point(s) in patients undergoing Stereotactic Surgery for procedures in the cortical bone of the vertebrae. The Precision Screw can be used as an accessory with frameless navigation systems.

Device Description

The Precision Screw is a self-drilling metallic fixation device used only as a reference point during stereotactic procedures. Commonly known as a Fiducial Screw or a stereotaxic instrument, the Precision Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.

AI/ML Overview

The provided document pertains to the 510(k) premarket notification for the "Precision Screw" device and focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data in the typical sense of a clinical or standalone AI performance study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this type of regulatory submission. The document emphasizes non-clinical testing for safety and technological equivalence.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format. Instead, it refers to fulfilling standards and demonstrating equivalence to a predicate device. The performance is reported in terms of meeting these standards and being "highly visible and fit for the purpose."

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Conforms to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Titanium material conforms to ASTM F136.
Mechanical Strength & Integrity	Meets performance standards identified in ASTM F543-13 and ISO 6475:1989 for torsional properties and driving torque.
Visual Acuity/Visibility (Frameless Navigation)	Screws are "highly visible and fit for the purpose they are intended for in the operative setting" when inserted into a Spinal Bone Model and assessed with O-Arm images.
Sterilization	Sterilization has been validated.
Anatomic Location Safety	Viable anatomic locations on the vertebrae were evaluated for safety and identified in the labeling.

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 for any of the non-clinical tests mentioned. For the "Visual Acuity" test, it mentions "inserting Precision Screws into a Spinal Bone Model" but does not give a number of screws or models used.
Data Provenance: Not explicitly stated. The submitter is Cryptych Pty Ltd. based in Australia. The testing standards (ASTM, ISO) are international. The location of the testing laboratories is not provided. The data is non-clinical (bench testing), not patient data.

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. The tests performed are non-clinical (biocompatibility, mechanical strength, visibility on imaging models) and do not involve expert consensus on diagnoses or interpretations of patient data. For the "Visual Acuity" test, no mention of expert readers or their qualifications is provided; it states "The visibility of the Precision Screw on O-Arm images... was assessed."

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

Not applicable. This type of adjudication method is used in clinical studies involving multiple human readers for diagnostic tasks, which is not what was performed.

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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (a screw for navigation), not an AI-powered diagnostic or assistive tool. The document states: "clinical testing was not required to support substantial equivalence."

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

No, a standalone algorithm performance study was not done. The device is a physical screw.

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

The concept of "ground truth" (in the sense of a gold standard for a diagnostic algorithm) is not directly applicable to the non-clinical tests conducted for this physical device. Instead, the "truth" is established by:

Adherence to recognized international standards (e.g., ASTM F136 for material, ASTM F543-13 and ISO 6475:1989 for mechanical properties, ISO 10993 for biocompatibility).
Validation against expected performance for a physical device (e.g., "Sterilization has been validated," "Screws are highly visible and fit for the purpose").

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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

July 27, 2016

Cryptych Pty Ltd. % Mr. Dave Thomson Director and QA /RA Manager Strategic Medical Compliance 42 Fountains Road Narara. NSW 2250 Australia

Re: K160385

Trade/Device Name: Precision Screw Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 17, 2016 Received: June 27, 2016

Dear Mr. Thomson:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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

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,

Carlos L. Pena -S/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160385

Device Name Precision Screw

Indications for Use (Describe)

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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Precision Screw Traditional 510(k) Premarket Notification

510(K) SUMMARY AS PER 21 CFR 807.92 (C)

.1 SUBMITTER

Submitter:	Cryptych Pty Ltd.
Address:	Suite 106, 275 Alfred Street, North Sydney, NSW 2060 AUSTRALIA
Phone:	+61 414 899 799
Contact Person:	David Thomson
Date Prepared:	4th December 2015, updated 22nd July 2016
.2
DEVICE
Name of Device:	Precision Screw
Model:	CRY01

Common or Usual Name: Fiducial Bone Screw or Stereotactic Instrument

Classification Name: Stereotactic Instrument or Accessory (21 CFR 882.4560)

Regulatory Class: ll

Product Code: OLO Reason for Submission New Device

.3 PREDICATE DEVICE

Lorenz Fiducial Screw, K010427

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

.4 DEVICE DESCRIPTION

.5 INDICATIONS FOR USE

The Precision screw is intended for establishing fixed reference point(s) in patients undergoing Stereotactic Surgery for procedures in the cortical bone of the vertebrae. The Precision Screw can be used as an accessory with frameless navigation systems.

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Sponsor: Cryptych Pty Ltd

Precision Screw Traditional 510(k) Premarket Notification

Feature	Precision ScrewK160385	Lorenz Fiducial ScrewK010427
Intended use	Fiducial marker used by a framelessnavigation system to identify a fixedreference point during surgery	Fiducial marker used by a framelessnavigation system to identify a fixedreference point during surgery
Anatomical Site	Vertebral bone	Bone
Material	Biocompatible metal(Titanium alloy)	Biocompatible metal(Titanium)
Reprocessing	Provided sterile,Single use	User sterilized,Single use
Insertion method	Self tapping threads inserted with amechanical driver	Self tapping threads inserted with amechanical driver

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE .6

The Precision screw has similar characteristics to the Lorenz predicate. Notable differences are that the Precision screw is delivered sterile and is specified for vertebral use. However, these differences have been shown to not impact the safety and effectiveness of the Precision screw:

Sterilization has been validated
Viable anatomic locations on the vertebrae were evaluated for safety and identified in the labeling. ●

Since most features are equivalent and new features do not add risk, the Precision screw system is equivalent to the predicate.

1.7 PERFORMANCE DATA

Since the predicate device was cleared based in part on the results of clinical studies, and since the comparison of bench testing to clinical outcomes is well understood for this type of device, clinical testing was not required to support substantial equivalence. The non-clinical data provided supports the safety of the device and its technological equivalence to the predicate device.

The following performance data were provided in support of the substantial equivalence determination.

- Biocompatibility testing

The biocompatibility evaluation for the Precision Screw was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Precision Screw is considered as permanent implants. The titanium material conforms to ASTM F136 for chemical composition and is suitable for surgical implant applications.

- Mechanical strength and integrity testing

The mechanical testing performed on the Precision Screw demonstrates that it meets the performance standards identified in ASTM F543-13 and ISO 6475:1989, for determining the torsional properties and driving torque of the Precision Screw.

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Sponsor: Cryptych Pty Ltd

Precision Screw

Traditional 510(k) Premarket Notification

Visual Acuity using a suitable frameless navigationsystem

The visibility of the Precision Screw on O-Arm images and the suitability for its use for spinal navigation was assessed by inserting Precision Screws into a Spinal Bone Model developed specifically for this tests performed on these screws serve to confirm that the screws are highly visible and fit for the purpose they are intended for in the operative setting.

1.8 SUMMARY

The Precision Screw is substantially equivalent to the Lorenz Fiducial Screw both in terms of its intended use, design and the fundamental scientific technology. The Precision Screw was found to have a safety and effectiveness profile that is similar to the predicate device. The Lorenz Fiducial Screw was cleared by FDA in K010427.

1.9 CONCLUSIONS

The Precision Screw is substantially equivalent to the predicate device (Lorenz Fiducial Screw K010427).

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).