Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts and implant positioning during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, relative to a CT or MR based model of the anatomy.

Example orthopaedic procedures for these instruments include, but are not limited to:

Total Joint Replacement (TJR)
Revision Surgery of TJR
Tumor resection and Bone/Joint Reconstruction

Device Description

DePuy CAS Hip Instruments are computer recognized by application specific VectorVision Hip software on Ci hardware platform, owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during orthopaedic hip surgery. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intraoperatively during surgery. BrainLAB designed the Ci hardware platform exclusively for DePuy. Instrument/implant data is tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and acetabular instrumentation and implants for the most accurate position.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

It is important to note that the provided documents (K052178 Summary of Safety and Effectiveness, and subsequent FDA correspondence) do not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them, in the typical sense of a performance study with metrics like sensitivity, specificity, accuracy, etc.

The document primarily focuses on establishing substantial equivalence to predicate devices for the purpose of 510(k) clearance. This means the device is deemed safe and effective because it is similar enough to devices already on the market. The "study" here is more of a demonstration of similarity and shared characteristics rather than a rigorous performance evaluation against predefined metrics.

However, I will extract what information is present related to equivalency and performance.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a Computer Assisted Surgery (CAS) Hip Instrumentation device emphasizing substantial equivalence, "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as its predicates, rather than achieving specific numerical performance thresholds (e.g., 95% accuracy).

From the provided text, the core "performance" of the device is its ability to track instruments and allow for accurate navigation. The "acceptance criteria" would thus implicitly revolve around the successful demonstration of this functionality, as evidenced by its similarity to predicate devices.

Acceptance Criteria Category	Specific Criteria (Inferred from substantial equivalence)	Reported Device Performance (Inferred from substantial equivalence)
Intended Use	Device's intended use is consistent with predicate devices for computer-assisted orthopaedic hip surgery.	Device enables operational planning and navigation during orthopaedic hip surgery, consistent with predicate devices.
Technological Characteristics	Device utilizes recognized technology for tracking and navigation (infrared passive markers, 3D computer image of patient's bone).	Device tracks instrument/implant data via flexible passive markers on a virtual computer 3D image for intraoperative navigation, consistent with predicate devices.
Safety and Effectiveness	Device provides a similar level of safety and effectiveness as legally marketed predicate devices.	The FDA determined the device is substantially equivalent to legally marketed predicate devices, implying similar safety and effectiveness.
Accuracy of Navigation	Implicitly, the device should allow surgeons to accurately navigate the position of instrumentation, similar to predicates. (No quantitative metric provided.)	"Enable a surgeon to accurately navigate the position of instrumentation...for precise hip reconstructive procedures." (Qualitative statement, no quantitative data.)

Study Details (Based on Substantial Equivalence Justification)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly mentioned. In a 510(k) for substantial equivalence, a "test set" in the sense of a clinical trial or performance study with quantified metrics against ground truth is often not required or present in the summary. The demonstration is typically based on technical characteristics, engineering testing, and comparison with predicate devices.
- Data Provenance: Not explicitly mentioned for any specific test data. The submission relies on the established safety and effectiveness of the listed predicate devices (K040368, K033223, K033341, K021798), which are already marketed in the US. The "study" isn't a new clinical trial; it's a comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. There is no indication of an external "test set" requiring expert consensus for ground truth as part of this 510(k) submission. Substantial equivalence relies on the regulatory body's assessment of similarity.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This type of adjudication is typically for clinical studies involving reader evaluations, which isn't described here.
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 mentioned or described. This device is not an AI/CAD system for image interpretation, but rather a navigation system used during surgery. The concept of "human readers improving with AI" does not apply to this device's function.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The device is explicitly described as "instrumentation," "hardware," and "software" that "enable operational planning and navigation during orthopaedic hip surgery." It is inherently a "human-in-the-loop" system, assisting the surgeon. There is no concept of its performance in a standalone (algorithm-only) capacity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly defined for a "study" of the DePuy CAS Hip Instrumentation device itself. For substantial equivalence, the "ground truth" is that the predicate devices have been proven safe and effective through prior regulatory processes (which might have involved clinical data, engineering tests, etc., but those details are not in this document). The ground truth for this device is its similarity to those predicates.
The sample size for the training set:
- Not applicable/Not mentioned. The document does not describe a machine learning algorithm that requires a "training set" in the conventional sense. The "software" reads instrument and implant data, likely following predefined algorithms and anatomical models, not adaptive learning from a training set.
How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there is no described training set.

Summary of "Study" in the Context of a 510(k) for this Device:

The "study" for this 510(k) is essentially a comparison to predicate devices to demonstrate substantial equivalence. The document states:

"Computer Assisted Surgical Hip Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments by means of tracking patient anatomy through infrared passive markers imposed onto computer images."

This statement is the core of the "study" and its conclusion. It establishes that because the new device uses the same fundamental technology (infrared passive markers, 3D imaging), has the same intended use (navigating hip surgery), and similar technological characteristics as already-cleared devices, it is considered equally safe and effective, and thus "meets acceptance criteria" for market clearance. No independent, quantitative performance study with specific metrics is detailed in this summary.

Summary

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0C1 2 1 2005

K052178 SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Firm:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) Contact:	Randa FranklinSr. Regulatory Specialist
Trade Name:	DePuy CAS Hip Instrumentation
Common Name:	Computer Assisted Surgery (CAS) HipInstrumentation
Regulatory Classification:	882.4560; Stereotaxic Instrument; Class II
Device Product Code:	HAW
Substantially Equivalent Device:	• K040368 VectorVision Hip
	• K033223 Zimmer Ortho Guidance Systems –Hip Instruments
	• K033341 Smith & Nephew Image-GuidedSurgical Instruments for Hip Applications
	• K021798 Image Guided Surgical Instrumentsfor Hip Applications

Device Description and Intended Use:

Basis of Substantial Equivalence:

Computer Assisted Surgical Hip Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments by means of tracking patient anatomy through infrared passive markers imposed onto computer images.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randa Franklin Sr. Regulatory Specialist DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K052178

Trade/Device Name: DePuy CAS Hip Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 4, 2005 Received: October 5, 2005

Dear Mr. Franklin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve roviewed your 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 for ass stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to commer of prior to 1125 2011 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2- Randa Franklin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally premaince health a device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectoral International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

farbine Buehns

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle followed by the word "DePuy" in a bold, sans-serif font. A horizontal line underlines the word "DePuy". Below the line, in a smaller font, is the text "a Johnson-Johnson company".

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: DePuy CAS Hip Instrumentation

Indications for Use:

Instruments are tracked by a passive marker sensor system that acquires landmarks of the instruments are trucked by a pacerro mouter hardware and software. This enables a bone surface when interrasod with bosition of instrumentation by a virtual 3-D computer surgeon to accurately navigato the position on on the perative hip reconstructive generated image for proclos bensted for any medical condition in which the use of procedures. The system'is indication for any where reference to a rigid anatomical structure, stereotaxe surgery may be approphato, antive to a CT or MR based model of the anatomy.

Example orthopaedic procedures for these instruments include, but are not limited to:

· Total Joint Replacement (TJR)
·Revision Surgery of TJR
· Tumor resection and Bone/Joint Reconstruction

Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of of of

(Posted November 13, 2003)
Jan Marie Buehler for Nixon

Division of General, Restorative, and Neurological Devices

510(k) Number K052178

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).