The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

Device Description

The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

Different handles (Large, Standard, for use with Rotating Shafts)
Different shaft lengths (6-14 inches)
Different Bite Sizes (0.5-6 mm)
Different Angles (40° and 90°, up and down)
Different Footplates (Standard, Thin and Ultra-Thin)
With or without ejector
Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ace Medical Surgical Instruments, based on the provided FDA 510(k) summary:

This device is a manual surgical instrument (rongeur), not an AI/ML-driven device. Therefore, many of the typical AI/ML study components (like expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable. The studies focus on the physical and functional characteristics of the surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Mechanical Strength	The predicate device (Fehling Punches) demonstrated fatigue resistance and appropriate cutting displacement in relation to applied force. The subject device must be identical to the predicate in materials, manufacture, design, and function to meet this.	The subject device is identical to the predicate in materials, manufacture, design, and function. No further mechanical testing was conducted as direct testing on the subject device was deemed unnecessary due to this identity.
Cleaning	Instruments must be free of visible soil and meet acceptance criteria for protein and hemoglobin content as specified by AAMI TIR 30:2011.	Instruments were free of visible soil and met acceptance criteria for protein and hemoglobin content per AAMI TIR 30:2011.
Sterilization	Sterilization parameters must provide a sterility assurance level (SAL) of 10^-6.	Sterilization parameters will provide a sterility assurance level of 10^-6.
Biocompatibility	The device materials and manufacturing processes must be biocompatible, consistent with the predicate.	The subject device is identical to the predicate in materials, manufacturing processes, manufacturer, sterilization, and technical specifications. No further biocompatibility testing was required.

2. Sample Size Used for the Test Set and Data Provenance

Mechanical Strength: The summary indicates that the predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing. The specific sample size for this predicate testing is not provided in this document. The subject device was deemed identical, so no separate test set was used for mechanical strength for the subject device.
Cleaning: A cleaning validation was performed on a "worst case instrument." This implies a single instrument or a very small sample to represent the most challenging cleaning scenario.
Sterilization: The validation used a "half-cycle approach," which is a common method for sterilization cycle validation, but the exact sample size (number of devices or cycles performed) is not specified.
Biocompatibility: No specific test set was used for the subject device as it was determined to be identical to the predicate.

Data Provenance: Not applicable in the context of clinical data for a manual surgical instrument. The tests are laboratory/benchtop validations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for tests related to mechanical, cleaning, sterilization, and biocompatibility of a manual surgical instrument. Ground truth is established by test standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable for these types of benchtop tests. Results are typically determined by measurement against established standards rather than expert adjudication.

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. This is a manual surgical instrument, not an AI-driven device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a manual surgical instrument.

7. The Type of Ground Truth Used

Mechanical Strength: Ground truth is based on the performance characteristics of the predicate device as demonstrated through static and dynamic mechanical testing against engineering specifications for fatigue and cutting displacement.
Cleaning: Ground truth is established by adherence to a recognized standard: AAMI TIR 30:2011 for protein and hemoglobin content, and visual inspection for soil.
Sterilization: Ground truth is established by achieving a specific sterility assurance level (SAL) of 10^-6, which is a recognized regulatory benchmark for sterility.
Biocompatibility: Ground truth is established by the predicate device's proven biocompatibility and the material equivalence of the subject device. Compliance with material standards (ASTM F899) is also implied.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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July 21, 2020

Ace Medical % Cassandra Petrov Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K200387

Trade/Device Name: Ace Medical Surgical Instruments Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE, HTX Dated: June 15, 2020 Received: June 19, 2020

Dear Cassandra Petrov:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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).

Sincerelv.

Adam D. Pierce -S 2020.07.21 14:23:56 -04'00'

Adam D. Pierce, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K200387

Device Name Ace Medical Surgical Instruments

Indications for Use (Describe)

The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

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

Submitted By:	Ace Medical Co.2230 Park Ave. #202Cincinnati, OH 45206
Date:	July 21, 2020
Contact Person:Contact Telephone:Contact Fax:	Cassandra Petrov, Regulatory Engineer(440) 541-0060(440) 933-7839
Device Trade Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Predicate Device:	Ace Medical Surgical Instruments882.4840 Manual Rongeur, 888.4540 Orthopedic Manual Surgical InstrumentClass II , Class INeurology, OrthopedicHAE, HTXFehling Punches (K153243)Integra Kerrison Rongeurs (K150428)
	The predicate device has never been subject to recall.

Device Description:

Different handles (Large, Standard, for use with Rotating Shafts) ●
Different shaft lengths (6-14 inches) ●
Different Bite Sizes (0.5-6 mm) .
Different Angles (40° and 90°, up and down) .
Different Footplates (Standard, Thin and Ultra-Thin)
With or without ejector
. Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

Intended Use:

The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

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Summary of Technological Characteristics:

The Ace Medical Surgical Instruments are identical to the predicate as they are manufactured by the same company, have the same intended use and the same fundamental scientific technology. Both devices are identical in several aspects which are summarized in the table below. A more detailed comparison of the Ace Medical Surgical Instruments with predicate and reference predicate devices is included in this submission.

Table 1. Technological Characteristics Comparison

Verification and Validation Testing:

Test	Test Summary	Result
Mechanical Strength	The Fehling Punches (predicate)	The subject device is identical to
	were subject to static and	the predicate in materials,
	dynamic mechanical testing to	manufacture, design, and
	demonstrate fatigue resistance

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	and cutting displacement inrelation to force applied.	function. No further mechanicaltesting was conducted.
Cleaning	A cleaning validation wasperformed on worst caseinstrument per the processprovided in the IFU.	Instruments were free of visiblesoil and met acceptance criteriafor protein and hemoglobincontent per AAMI TIR 30:2011.
Sterilization	A steam sterilization validationwas performed using the halfcycle approach.	Sterilization parameters willprovide a sterility assurancelevel of 10-6.
Biocompatibility	The predicate device wasdeemed biocompatible. Thesubject device is identical to thepredicate in materials,manufacturing processes,manufacturer, sterilization, andtechnical specifications.	No further biocompatibilitytesting is required.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

§ 882.4840 Manual rongeur.

(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).