The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.

The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:

Cycle Type: Pre-vacuum Temperature: 132°C (270°F) Exposure Time: 4 minutes Dry Time: 30 minutes

Device Description

The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray.

AI/ML Overview

The provided text describes a medical device, the "iTotal Family Reusable Instrument Tray," and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not contain the specific details required to fully address your request in the format of acceptance criteria, device performance, and study characteristics.

Here's an attempt to extract and infer the information based on the provided text, while highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets and corresponding "reported device performance." Instead, it discusses "similarity" to predicate devices, which implies that the device must perform adequately in the tested areas, consistent with the predicates.

Based on the "Testing was performed to establish similarity" section and the "Device Comparison Table," we can infer the tested characteristics and the implicit performance required (i.e., demonstrated to be similar or meet functional requirements for a sterilization tray).

Acceptance Criteria (Implied)	Reported Device Performance (Inferred from "similarity" and testing)
Cleaning and Disinfection Validation: The device must withstand and be effectively cleaned through the validated methods.	Testing demonstrated the device is similar to predicate devices, indicating it withstands and is effectively cleaned.
Sterilization and Dry Time Validation: The device must allow for effective steam sterilization and drying within specified parameters.	Testing demonstrated the device is similar to predicate devices, indicating successful sterilization and drying.
Shelf Life Testing: The device must maintain its integrity and functionality over its intended shelf life.	Testing demonstrated the device is similar to predicate devices, implying its durability over time.
Reprocessing Fatigue Simulation: The device must withstand repeated reprocessing cycles without compromising functionality.	Testing demonstrated the device is similar to predicate devices, indicating its ability to endure repeated reprocessing.
Indication for Use: Must align with stated purpose of housing instruments for sterilization, transport, and storage.	The device meets its defined indication for use.
Maximum Load Capacity: Must safely hold up to 17 pounds of instruments.	Demonstrated to hold up to 17 pounds, which is comparable to or exceeds predicate devices.
Sterilant Penetration: Must allow for adequate sterilant penetration.	Confirmed to allow sterilant penetration ("Yes").
Microbial Barrier Properties: Must function effectively with an FDA cleared sterilization wrap to maintain sterility.	Confirmed for use with an FDA cleared wrap ("For use with an FDA cleared wrap").
Material Compatibility with Sterilization Method: Materials must be compatible with steam sterilization.	Confirmed as compatible ("Yes"), and materials (Aluminum, Radel R5000, Silicone Medical Grade Class 6) are noted.

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

Sample Size for Test Set: Not mentioned. The document states that "non-clinical testing was conducted," but it does not specify the number of units or cycles tested for each of the validations (Cleaning, Sterilization, Shelf Life, Reprocessing Fatigue).
Data Provenance: The testing was conducted by the submitter, ConforMIS, Inc., located in Billerica, MA, USA. The studies are retrospective in the sense that they are conducted on a manufactured device to demonstrate its performance against established standards and predicate devices, rather than a prospective clinical trial.

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

Number of Experts: Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation or subjective assessments. For a physical device like a sterilization tray, "ground truth" is established through standardized laboratory testing (e.g., measuring sterilization efficacy, material degradation, and mechanical integrity) against engineering specifications and regulatory guidelines, rather than expert consensus on interpretive data.
Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not mentioned. As noted above, this kind of testing does not typically involve adjudication in the medical imaging or diagnostic sense. The results of the non-clinical tests would be objectively measured and reported.

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 type of study is completely irrelevant to the device described, which is a physical sterilization tray, not an AI-powered diagnostic or interpretive tool.

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

Standalone Performance: No. This terminology applies to AI algorithms. The device is a physical product, and its "standalone performance" refers to its functional characteristics (like holding instruments, allowing sterilization) as validated by the non-clinical tests.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for this device's performance is based on objective, measurable criteria established by:
- Regulatory standards and guidance for sterilization and reprocessing.
- Engineering specifications for material properties, structural integrity, and validated sterilization cycle parameters.
- Performance data from legally marketed predicate devices (Signia™ Sterilization Tray K161347 and iDrive™ Ultra Sterilization Tray K130532), which serve as benchmarks for "similarity."

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not mentioned. This device does not involve machine learning or AI, and therefore no "training set" of data would be used. The design and validation are based on engineering principles and regulatory compliance.

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

How Ground Truth for Training Set was Established: Not applicable/Not mentioned. As there is no training set, there is no ground truth for it.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (sterilization tray), focusing on demonstrating "substantial equivalence" through non-clinical performance testing. It does not involve AI, image analysis, or clinical studies with human readers, which are the contexts for many of your questions.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

ConforMIS, Inc Emmaniel Nyakako Sr. Vice President, Quality and Regulatory Affairs 28 Crosby Drive Bedford, Massachusetts 01730

Re: K170226

Trade/Device Name: iTotal Family Reusable Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 25, 2017 Received: September 26, 2017

Dear Emmaniel Nyakako:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170226

Device Name iTotal Family Reusable Instrument Tray

Indications for Use (Describe)

The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 171bs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.

The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:

Cycle Type: Pre-vacuum Temperature: 132°C (270°F) Exposure Time: 4 minutes Dry Time: 30 minutes

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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6.0 510(K) SUMMARY (K170226)

Submitter's Nameand Address:	ConforMIS, Inc.600 Technology Park DriveBillerica, MA 01821
EstablishmentRegistrationNumber:	3009844603 and 3004153240
Date of Summary:	October 17, 2017
Contact Person:Telephone Number:Fax Number:	Emmanuel O. Nyakako, Sr. Vice President, Quality andRegulatory Affairs(781) 345-9164(781) 345-0147
Name of the Device:	iTotal® Family Reusable Instrument Tray
Common Name:	Sterilization Tray
Regulatory Statusand RegulationNumber:	Class II21 CFR 880.6850
ClassificationName:	Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories
DeviceClassification:	Product Code:KCT: Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories

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510(K) SUMMARY (K170226)

Indications for Use:	The iTotal Family Reusable Instrument Tray is intended to house the ConforMIS reusable instrumentation associated with ConforMIS knee implant systems and define their organization and configuration during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
	Cycle Type	Temperature	Exposure Time	Dry Time
	Pre-vacuum	132°C(270°F)	4 minutes	30 minutes
Identification of the Legally Marketed Devices (Predicate Devices):	Signia™ Sterilization TrayDevice Class: IIProduct Code: KCTRegulation Number: 21 CFR 888.6850510(k) Number: K161347iDrive™ Ultra Sterilization TrayDevice Class: IIProduct Code: KCTRegulation Number: 21 CFR 880.6850510(k) Number: K130532

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510(K) SUMMARY (K170226)

Device Description: The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray. The tray may contain the following instruments: . Keel punches (not to exceed 6 per load) . Patella clamp (not to exceed 1 per load) . Angel wing resection quide (not to exceed 1 per load) . Alignment rod tapers (not to exceed 2 per load) . Drill bits and adaptors (not to exceed 6 per load) ● Coring tool with adaptors (not to exceed 1 per load) . Pin puller (not to exceed 1 per load) ● Impactor handles, heads, and tips (not to exceed 5 per load) . Townley caliper (not to exceed 1 per load) ● Patellar osteotomy guide (not to exceed 1 per load)
- . Patella trials (not to exceed 5 per load)
- . Patella sizers (not to exceed 5 per load)
- . Guidance plugs (not to exceed 2 per load)
- . Steinman pins (not to exceed 7 per load)
- . Tack pins (not to exceed 3 per load)

The ConforMIS iTotal Family Reusable Instrument Tray is similar to the following cleared devices:

Signia™ sterilization tray (K161347) .
. iDrive™ Ultra sterilization tray (K130532)

Summary of The iTotal Family Reusable Instrument Tray is designed to Technological withstand the indicated cleaning and sterilization conditions to aid Characteristics: in storage and sterilization of the iTotal knee accessories. The tray itself is made primarily of aluminum and doesn't require any special storage conditions. Repeated processing according to the instructions for use has been shown to have minimal effect on the sterilization tray.

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510(K) SUMMARY (PAGE 4 OF 4)

Device Comparison	The iTotal Family Reusable Instrument Tray, subject of thispremarket notification, is similar to the predicate devices: SigniaTMSterilization Tray (K161347, cleared September 7, 2016), andiDriveTM Ultra Sterilization Tray (K130532, cleared May 20, 2013).Non-clinical testing was conducted to confirm that the iTotal FamilyReusable Instrument Tray is similar to the predicates.
Discussion:

Specifically, the following testing was performed to establish similarity:

Cleaning and Disinfection Validation .
. Sterilization and Dry Time Validation
. Shelf Life Testing
Reprocessing Fatigue Simulation .

All testing has demonstrated that the device is similar to the predicate devices.

A detailed comparison of the subject device with the predicate sterilization trays is provided in the following Device Comparison Section of this document.

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DEVICE COMPARISON

Characteristic	iTotal Family Reusable Instrument Tray(This submission)	Signia™ sterilization tray (K161347)	iDrive™ Ultra sterilization tray (K130532)
Indication for Use	The iTotal Family Reusable Instrument Tray isintended to house the ConforMIS reusableinstrumentation associated with ConforMIS kneeimplant systems and define their organization andconfiguration during sterilization, transportation,and storage within the hospital environment. TheiTotal Family Reusable Instrument Tray can holdup to 17lbs of instruments. The iTotal FamilyReusable Instrument Tray is only intended tomaintain sterility of the enclosed devices if it isused in conjunction with an FDA clearedsterilization wrap and has only been evaluated fora non-stacked configuration.The tray is intended to allow steam sterilization ofthe enclosed medical devices. The validatedsterilization cycle parameters are as follows:Cycle TypeTemperatureExposureDry Time	The Signia™ sterilization tray is intended toprovide storage for the Signia™ adapters,Signia™ reusable insertion guide and Signia™manual retraction tool during sterilization,storage and transportation within the hospitalenvironment. The Signia™ sterilization tray isonly intended to maintain sterility of theenclosed devices if it is used in conjunction withan FDA cleared sterilization wrap and has onlybeen evaluated for a non-stacked configuration.The tray can contain at a maximum: one (1)Signia™ adapter, one (1) Signia™ reusableinsertion guide and one (1) Signia™ manualretraction tool. The tray is intended to allowsteam sterilization of the enclosed medicaldevices. The validated sterilization cycleparameters are as follows:132 °C Pre-vacuum (HiVac) Steam CyclesTemperature: 270 °F (132 °C)Exposure: 4 minutesDry Time: 20-40 minutes134 °C Pre-vacuum (HiVac) Steam CyclesTemperature: 273 °F (134 °C)Exposure: 3 minutesDry Time: 20-40 minutes	The iDrive™ Ultra sterilization tray, an over-the-counter, accessory, is intended toprovide storage for the iDrive™ Ultrapowered stapling system duringsterilization, storage and transportationwithin the hospital environment. The traycan contain at a maximum: one (1) iDrive™Ultra powered handle, two (2) Endo GIA™adapters, two (2) iDrive™ battery insertionguides and one (1) iDrive™ Ultra manualadapter tool. The tray is intended to besterilized by the following cycles:Prevacuum Steam Cycles132 C for 4 minutes134 C for 3 minutesVacuum Dry Time: 20
Enclosed devices forsterilization	The tray may contain the following instruments:• Keel punches (not to exceed 6 per load)• Patella clamp (not to exceed 1 per load)• Angel wing resection guide (not toexceed 1 per load)	The tray can contain at maximum:One (1) Signia™ adapter,One (1) Signia™ reusable insertion guideAndOne (1) Signia™ manual retraction tool.	The tray can contain at a maximum:one (1) iDrive™ Ultra powered handle,two (2) Endo GIATM adapters,two (2) iDrive™ battery insertion guides andone (1) iDrive™ Ultra manual adapter tool
Characteristic	iTotal Family Reusable Instrument Tray(This submission)	Signia™ sterilization tray (K161347)	iDrive™ Ultra sterilization tray (K130532)
	Alignment rod tapers (not to exceed 2 per load) Drill bits and adaptors (not to exceed 6 per load) Coring tool with adaptors (not to exceed 1 per load) Pin puller (not to exceed 1 per load) Impactor handles, heads, and tips (not to exceed 5 per load) Townley caliper (not to exceed 1 per load) Patellar osteotomy guide (not to exceed 1 per load) Patella trials (not to exceed 5 per load) Patella sizers (not to exceed 5 per load) Guidance plugs (not to exceed 2 per load) Steinman pins (not to exceed 7 per load) Tack pins (not to exceed 3 per load)
Dimensions	Base layer of the tray: 20.59" (L) X 9.84" (W) X 13.32" (H)Accessory Box: 6.000" (L) X 2.500" (W) X 1.200" (H)	Approx. 10.0 x 21.4 x 3.0 (H) inches	Approx. 10 x 21x 3 (H)
Sterilization methods	Pre-vacuum steam	Pre-vacuum steam	Pre-vacuum steam
Steam SterilizationParameters	Cycle Type: Pre-vacuumTemperature: 132°C (270°F)Exposure: 4 minutesDry Time: 30 minutes	Pre-vacuum (HiVac) Steam CyclesTemperature: 132°C (270°F)Exposure: 4 minutesDry Time: 20 - 40 minutes	Prevacuum Steam Cycles132 C for 4 minutes134 C for 3 minutesVacuum Dry Time: 20
Base & Lid Materials	Trays and accessory box: AluminumTray Lid: Radel R5000Base Inserts (Grommets) – Silicone MedicalGrade Class 6	Stainless Steel	Base - AluminumLid- AluminumBase Inserts (Grommets) - Silicone MedicalGrade Class 6
Characteristic	iTotal Family Reusable Instrument Tray(This submission)	Signia™ sterilization tray (K161347)	iDrive™ Ultra sterilization tray (K130532)
Stacking	Do not stack trays in the autoclave chamber.Stacking of trays will adversely affect sterilizationand drying effectiveness.	Do not stack cases and trays in the sterilizationchamber.	Do not stack cases and trays in thesterilization chamber. Stacking of cases andtrays will adversely affect sterilization anddrying effectiveness.
Max. Load Capacity	17 pounds	10 pounds	15 pounds
SAV/Hole Pattern	The ratio of total surface area of openings tovolume (SAV) is: 52.3 in²/641.7 in³ (excludingaccessory caddy).Accessory Box: Evenly distributed hole pattern	Evenly distributed hole pattern	Evenly distributed hole pattern
Product Code	KCT	KCT	KCT
Sterilant Penetration	Yes	Yes	Yes
Microbial BarrierProperties	For use with an FDA cleared wrap	For use with an FDA cleared wrap	For use with an FDA cleared wrap
Material Compatibilitywith Sterilization Method	Yes	Yes	Yes

Table: Device Comparison Table

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Conclusion: Based upon the supporting data above, the subject device iTotal® Family Reusable Instrument Tray (K170226) is as safe and effective as the legally marketed devices Signia™ Sterilization Tray (K161347) and iDrive™ Ultra Sterilization Tray (K130532).

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).