The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for aligning of the implant are identifiable on patient imaging scans.

The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System remain the same as those cleared in the manufacturer's clearance for the implant system.

Device Description

The UNIKO PointCloud™ Knee Instruments use the TKA surqical plan that is output from the Vault® System Surgical Planning Software which was previously cleared by FDA through K124051. The surgeon plans a primary total knee replacement surgery using the Vault System and the output data file from the individualized surgical plan is utilized by the UNIKO PointCloud™ Knee Instruments (the subject of this submission) to create the necessary files for the production of patient specific cutting guides for the initial cuts to the distal femur and proximal tibia.

The UNIKO PointCloud™ Knee Instruments are patient specific cutting guides which are machined from polyoxymethylene material by the by means of customized off-the-shelf software. These quides (also called jigs) aid the surgeon in making the initial distal femoral and the initial proximal tibial bone cuts along with establishing the references (for example AP, posterior condylar or transepicondylar (TEA) axis) for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants.

The UNIKO Knee Cutting Guides are patient specific and are intended as single use instruments compatible with TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the UNIKO PointCloud™ Knee Instruments, a surgical instrument system for Total Knee Replacement. It details the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific information required to answer all parts of your request, especially regarding "acceptance criteria" and the type of study typically associated with AI/ML-based medical devices (like MRMC studies, ground truth establishment for large datasets, and detailed performance metrics beyond general accuracy statements). The device described is a set of physical surgical instruments (cutting guides) derived from pre-operative planning software, not an AI/ML algorithm that interprets imaging or diagnoses conditions directly.

Therefore, many of your requested points related to AI/ML evaluation (like expert consensus for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not provided in this document.

I will fill in the information that is available in the document and explicitly state when information is not present or not applicable to this type of device.

Device Description: UNIKO PointCloud™ Knee Instruments

The UNIKO PointCloud™ Knee Instruments are patient-specific cutting guides (jigs) made from polyoxymethylene. These guides assist surgeons in performing initial distal femoral and proximal tibial bone cuts and establishing references for femoral orientations during Total Knee Arthroplasty (TKA) surgery. They are based on a pre-operative surgical plan generated by the Vault® System Surgical Planning Software (previously FDA cleared) using patient imaging data. After these initial cuts, conventional knee instrumentation is used for subsequent steps.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several "acceptance criteria" generally, but does not provide a specific table with quantitative thresholds. It states that the device "met the biocompatibility requirements," "met the user needs," and "within the acceptance criteria of the study" for various tests.

Test/Validation Area	Acceptance Criteria (as described)	Reported Device Performance
Biocompatibility Testing	Met Biocompatibility requirements per ISO 10993-1:2009 for limited exposure (up to 24 hours) of an external communicating device in direct contact to patient tissue.	Met: Biocompatibility testing demonstrated that the device met the requirements per ISO 10993-1:2009.
Cutting Guide Leg Alignment Validation	Capable of accurately producing the planned limb alignment from the Vault Software within the acceptance criteria of the study.	Met: The UNIKO PointCloud™ Knee Instruments are capable of accurately producing the planned limb alignment from the Vault Software within the acceptance criteria of the study. Could accommodate varus/valgus cut angles of up to +/- 10 Degrees for the femur and tibia for severe deformities.
Jig Design Accuracy Validation	Standard deviation of errors for varus/valgus angles, internal/external rotation, flexion/extension angles, and anterior/posterior slope angles were within the acceptance criteria of the protocol, given various levels of user training.	Met: Testing showed that the standard deviation of errors for the varus/valgus angles, internal/external rotation, flexion/extension angles and anterior/posterior slope angles were within the acceptance criteria of the protocol, even with varying user training levels.
Accuracy in Cadaver Testing Study	Comparable accuracy relative to planned values for resection thickness. At least comparable to accuracy achieved using conventional jig-based instrumentation reported in literature.	Met: The difference between the measured resection thickness versus that specified in the pre-operative plan demonstrated a comparable accuracy relative to the planned values. Accuracy was at least comparable to the accuracy achieved using conventional jig-based instrumentation reported in the literature.
Usability Validation	All surgical teams able to perform all steps outlined in the validation plan. Surgeon satisfaction with the system exceeded the acceptance criteria.	Met: All surgical teams were able to perform all steps outlined in the validation plan. The overall acceptance criteria of this usability study were met, and surgeon satisfaction with the system exceeded the acceptance criteria of the study. The studies validated that the instruments are a safe and effective means of performing TKA.

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

Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of patients/cases for the cadaver study or the human factors/usability study. It mentions a "cadaveric model" for accuracy testing and "all surgical teams" for usability.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. The descriptions suggest prospective testing within a cadaveric laboratory setting and a simulated clinical environment for usability. The pre-operative surgical plan is based on patient imaging scans (presumably from real patients, though no details are given on how these scans were acquired or sampled for the design/testing process).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the device is a physical instrument derived from a surgical plan. The "ground truth" for its performance is assessed by its physical accuracy, alignment, and usability in practical settings, compared to the pre-operative plan (which a surgeon approves). The document does not describe a clinical study where human experts (e.g., radiologists) are assessing images based on AI output.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This type of adjudication is typically relevant for studies involving human interpretation of medical images or data, especially when establishing ground truth for AI algorithms. For a surgical instrument, performance is assessed through engineering tests, dimensional accuracy, and functional usability within a simulated or cadaveric environment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done.
This type of study is specifically designed to evaluate the impact of AI assistance on the diagnostic performance of human readers (e.g., radiologists interpreting images). The UNIKO PointCloud™ Knee Instruments are physical surgical guides, not an AI diagnostic tool. Therefore, a MRMC study is not relevant to their evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not directly applicable in the sense of an AI diagnostic algorithm.
The device itself is a physical instrument. Its "performance" in a "standalone" sense would relate to its manufacturing accuracy and ability to fit the anatomy as planned.
The document mentions that the pre-op surgical plan is an "output from the Vault® System Surgical Planning Software" (previously cleared by FDA through K124051). The UNIKO instruments utilize this output. The "Accuracy in Cadaver Testing Study" assesses how accurately the instruments (the physical cutting guides) align with the pre-operative plan.
The process involves human approval ("Surgeon approves plan"), meaning it's a human-in-the-loop system in the overall surgical workflow, but the "device" itself is the physical guide, not the software.

7. The Type of Ground Truth Used

For the performance testing of the physical instruments:

Cutting Guide Leg Alignment Validation & Jig Design Accuracy Validation: The ground truth appears to be the pre-operative surgical plan output by the Vault System Surgical Planning Software, against which the manufactured jigs and their ability to guide cuts are compared. This pre-operative plan is surgeon-approved.
Accuracy in Cadaver Testing Study: The "ground truth" for this study is also the pre-operative surgical plan (i.e., the intended resection thickness and angles) compared to the actual resections performed using the UNIKO guides on cadavers. Comparison is also made against "literature values for conventional knee surgical instruments."
Usability Validation: The "ground truth" for usability is successful completion of surgical steps and surgeon satisfaction, likely assessed against predefined qualitative and quantitative metrics for task completion, errors, and user feedback.

8. The Sample Size for the Training Set

Not applicable/Not provided. The UNIKO PointCloud™ Knee Instruments are physical cutting guides. They are "manufactured based on surgical plan," not "trained" in the way an AI/ML algorithm is trained on a dataset. The software (Vault System Surgical Planning Software) that generates the surgical plan would have undergone its own development and validation, which might involve training data if it includes machine learning components, but those details are not provided in this 510(k) summary for the instruments.

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

Not applicable/Not provided. As explained in point 8, the product being cleared is a physical instrument, not an AI algorithm requiring a training set with established ground truth. The "training" of the plan-generating software (Vault System Surgical Planning Software) is outside the scope of this document.

Summary

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August 12, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Unik Orthopedics, Inc. Charlie Chi CEO 1701 Fortune Drive, Unit E San Jose, California 95131

Re: K193312

Trade/Device Name: UNIKO PointCloud™ Knee Instruments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Additional product code: OOG Dated: August 7, 2020 Received: August 7, 2020

Dear Charlie Chi:

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 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,

Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K193312

Device Name UNIKO PointCloud™ Knee Instruments

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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Image /page/3/Picture/0 description: The image contains the logo for UNIK Orthopedics. The word "UNIK" is written in large, blue, sans-serif font. Below the word "UNIK" is the word "ORTHOPEDICS" in a smaller, black, sans-serif font. The "O" in UNIKO is gray.

SECTION 6 510(k) SUMMARY

510(k) Number: K193312

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

Owner Name:	Unik Orthopedics, Inc.
Address:	1701 Fortune Drive, Unit E
	San Jose, CA 95131
Phone:	(408) 883-5842
Contact Person:	Charlie Chi, Ph.D.
Phone:	(408) 887-5842
Date Prepared:	11 August 2020

Device Information:

Classification:	Class II
Trade Name:	UNIKO PointCloud™ Knee Instruments
Common name:	Knee Cutting Guide
Classification name:	Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis;Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis
Regulation number:	21 CFR 888.3565 and 21 CFR 888.3560
Classification Code:	MBH, OOG

Predicate Device:

The UNIKO PointCloud™ Knee Instruments are substantially equivalent in Intended Use, Indications for Use, Materials, Fundamental Scientific Technology and Performance to the following legally marketed devices in commercial distribution: Zimmer Patient Specific Instrument System 6.0 which was cleared by FDA through K140027 and the Stryker ShapeMatch Cutting Guide cleared through K122053

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, bold, blue letters. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in smaller, black letters. The "O" in UNIKO is gray.

UNIKO PointCloud™ Knee Instruments Traditional 510(k) Submission

femoral and the initial proximal tibial bone cuts along with establishing the references (for example AP, posterior condylar or transepicondylar (TEA) axis) for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants.

The UNIKO Knee Cutting Guides are patient specific and are intended as single use instruments compatible with TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System remain the same those cleared in the manufacturer's clearance for the implant svstem.

Intended Use / Indication for Use:

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in quiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Substantial Equivalence:

Like the predicates, Zimmer Patient Specific Instruments System 6.0 and Stryker ShapeMatch Cutting Guides, the UNIKO PointCloud™ Knee Instruments are intended to be used as a Knee Arthroplasty Implantation System. A device accessory or set of device accessories that aids the surgeon in performing the implantation of the knee implant. Also, like the predicates, the UNIKO PointCloud™ Knee Instruments are indicated for use with femoral and tibial components of compatible FDA cleared total knee implant systems. Specifically, the UNIKO PointCloud™ Knee Instruments are cleared for use with the compatible femoral and tibia components of the FDA cleared uncemented DJO Surgical EMPWR 3D Knee System.

Technological Characteristics/Performance Data:

Substantial equivalence in materials and technological characteristics of the UNIKO PointCloud™ Knee Instruments and the predicate devices is outlined in the table below:

Product	UNIKO PointCloud™ Knee Instruments	Zimmer Patient Specific Instruments System 6.0	Stryker ShapeMatch Cutting Guides	Conclusion
510(k) number	Subject Device	K140027	K122053
Manufacturer	Unik Orthopedics Inc.	Materialise N.V.(Zimmer)	Stryker Corporation
Materials
Femur Jig Guide	polyoxymethylene	polyamide	polyoxymethylene	Substantially Equivalent
Product	UNIKOPointCloud™ KneeInstruments	Zimmer PatientSpecificInstruments System6.0	Stryker ShapeMatchCutting Guides
510(k) number	Subject Device	K140027	K122053	ConclusionSubstantiallyEquivalent
Manufacturer	Unik OrthopedicsInc.	Materialise N.V.(Zimmer)	Stryker Corporation
Femur Cutslot	polyoxymethylene	metal	polyoxymethylene
Tibia Jig Guide	polyoxymethylene	polyamide	polyoxymethylene	SubstantiallyEquivalent
Tibia Cutslot	polyoxymethylene	metal	polyoxymethylene	SubstantiallyEquivalent
Design
Two part jig andcutslot	Yes	Yes	NoOne Piece Jig &Cutslot	SubstantiallyEquivalent
Cutting Jigs aresingle use	Yes	Yes	Yes	SAME
Cutting Slotsare single use	Yes	No	Yes	SubstantiallyEquivalent
Cutting Guidesare providednon-sterile	Yes	Yes	Yes	SAME
TechnologicalCharacteristics
Softwarecreates pre-opsurgical planbased on MRIdata	Yes	Yes	Yes	SAME
Surgeonapproves plan	Yes	Yes	Yes	SAME
Patient specificcutting guidesmanufacturedbased onsurgical plan	Yes	Yes	Yes	SAME
Guides for initialdistal femoraland proximaltibial bone cuts	Yes	Yes	Yes	SAME
Implantmanufacturer'simplant specificguides used tocompleteimplant specificcuts	Yes	Yes	Yes	SAME

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Image /page/5/Picture/0 description: The image shows the logo for UNIK Orthopedics. The word "UNIK" is in large, blue, sans-serif font. Below it, the words "UNIK ORTHOPEDICS" are in a smaller, black, sans-serif font. The "O" in UNIK is gray.

UNIKO PointCloud™ Knee Instruments Traditional 510(k) Submission

Performance Testing

Biocompatibility testing demonstrates that the UNIKO PointCloud™ Knee Instruments, with limited exposure (up to 24 hours) of an external communicating device in direct contact to patient tissue, met the biocompatibility requirements per ISO 10993-1:2009.

Bench testing was performed on the UNIKO PointCloud™ Knee Instruments to verify and validate that the performance of the device meets the user needs and that the

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Image /page/6/Picture/0 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, bold, blue letters. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in smaller, black letters. The "O" in UNIKO is gray.

device is substantially equivalent to the predicate when used with compatible femoral and tibial components of the DJO Surgical EMPWR 3D Knee System.

Testing consists of the following:

Cutting Guide Leg Alignment Validation •
. Jig Design Accuracy Validation
. Accuracy in Cadaver Testing Study
. Usability Validation

The results of this testing demonstrated that the UNIKO PointCloud™ Knee Instruments are capable of accurately producing the planned limb alignment from the Vault Software within the acceptance criteria of the study. For patients with severe varus/valgus deformities, the UNIKO PointCloud™ Knee Instruments could accommodate varus/valgus cut angles of up to +/- 10 Degrees for the femur and tibia. Testing also showed that given various levels of training of users in designing the jigs for femur and tibia, the standard deviation of errors for the varus/valgus angles, internal/external rotation, flexion/extension angles and anterior/posterior slope angles were within the acceptance criteria of the protocol.

Testing also conducted to quantify the accuracy of the UNIKO PointCloud™ Knee Instruments cutting guides relative to the pre-op surgical plan output by the Vault System Surgical Planning Software in a cadaveric model and to assess the accuracy in relation to literature values for conventional knee surgical instruments that are not patient specific. The difference between the measured resection thickness versus that specified in the pre-operative plan demonstrated a comparable accuracy relative to the planned values. Furthermore, the accuracy of the UNIKO cutting quides for use in total knee arthroplasty was at least comparable to the accuracy achieved using conventional jigbased instrumentation reported in the literature.

Usability testing of the UNIKO PointCloud™ Knee Instruments in a simulated clinical environment was conducted and indicated that all surgical teams were able to perform all steps outlined in the validation plan. The overall acceptance criteria of this usability study were met and surgeon satisfaction with the system exceeded the acceptance criteria of the study. The usability studies succeeded in validating that the UNIKO PointCloud™ Knee Instruments are a safe and effective means of performing TKA.

Conclusion

In summary, the UNIKO PointCloud™ Knee Instruments are equivalent to the predicates, Zimmer Patient Specific Instrument System 6.0 (K140027) and the Stryker ShapeMatch Cutting Guide (K122053), in the following ways: it has the same intended use, similar Indications for Use, the same or similar technological characteristics and operating principles, incorporates the same basic design and incorporates the same or similar materials. The results of performance testing demonstrate that the UNIKO PointCloud™ Knee Instruments performed substantially equivalent to the predicates and did not raise any new questions of safety and effectiveness. The data presented supports a determination of Substantial Equivalence.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.