(201 days)
The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans.
The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments.
The Signature Glenoid Guide is intended for single use only.
Patient specific guides are designed and manufactured in plastic using additive manufacturing. The guides are developed using patient imaging scans, software, and the clinician approved/finalized pre-surgical plan. The guides facilitate the placement of metallic pins and can be used in conjunction with existing anatomic and reverse Biomet instrumentation and surgical techniques. Intraoperative placement of metallic bone pins in arthroplasty procedures.
The provided text describes the "Signature™ Personalized Patient Care System - Glenoid Guide System". However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format. The document is a 510(k) summary for a medical device and typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria.
Based on the provided information, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the given text. The document states: "Accuracy performance testing (cadaver lab) and Guide verification of post processing techniques and autoclave sterility deformation dimensional stability testing was performed to determine substantial equivalence. ... Testing verified that the accuracy and performance of the system is adequate to perform as intended."
This indicates that acceptance criteria existed and the device met them, but the specific metrics, targets, and actual results are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "accuracy performance testing (cadaver lab)," implying a test set was used, but the number of cadavers or individual measurements is not given.
- Data Provenance: The "accuracy performance testing" was conducted in a "cadaver lab." This suggests the data is prospective in nature using cadaver models. The country of origin is not specified, but the submission is to the U.S. FDA, implying the testing was likely conducted in or for the U.S. market.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the text. The device involves a "clinician approved/finalized pre-surgical plan," and the guides are intended to "assist in the positioning of glenoid components intra-operatively." This implies medical expertise is involved in the planning and surgical application, but specialists establishing ground truth for a test set are not mentioned.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No mention of an MRMC comparative effectiveness study is made. The document focuses on the device's accuracy and performance, not a comparison of human readers with and without AI assistance. The device itself is a surgical guide rather than an AI-driven image interpretation tool that would typically be evaluated with MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device is a "surgical instrument" designed to "assist in the positioning of glenoid components intra-operatively." It generates patient-specific guides using "imaging scans, software, and the clinician approved/finalized pre-surgical plan." This strongly implies that the device is not a standalone algorithm, but rather a tool that works as part of a human-in-the-loop process (surgeon + guide). The "accuracy performance testing" likely evaluated the guide's ability to accurately translate the surgical plan, which is a key component of the overall system.
7. The Type of Ground Truth Used:
The ground truth for the "accuracy performance testing" on cadavers is not explicitly defined in terms of how it was established (e.g., expert consensus, direct measurement, etc.). However, given that it's a surgical guide system, the ground truth would typically relate to the actual achieved position of pins/components in relation to the planned position as determined by the pre-operative imaging and surgical plan. This would likely involve direct physical measurement on the cadaver models post-use of the guide, referencing anatomical landmarks or planned targets.
8. The Sample Size for the Training Set:
This information is not provided. The document describes the system as using "patient imaging scans" and "software" to create models and guides. This suggests an underlying algorithm or system that would likely have been developed and "trained" or validated using a dataset, but the size of that dataset is not mentioned.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
Summary of what is known and unknown:
| Information Request | Extracted from Text |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not explicitly provided. Mentions "accuracy performance testing" and "Guide verification... dimensional stability testing" verified the system is "adequate to perform as intended." Specific metrics and thresholds are absent. |
| 2. Test Set Sample Size & Data Provenance | - Sample Size: Not explicitly stated.- Provenance: "cadaver lab" testing, implying prospective data acquisition using cadaver models. Country not specified. |
| 3. Number of Experts & Qualifications (for Test Set Ground Truth) | Not provided. |
| 4. Adjudication Method (for Test Set) | Not provided. |
| 5. MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | No. The device is a surgical guide system, not an AI for image interpretation that would typically warrant such a study. |
| 6. Standalone (Algorithm Only) Performance Study | No. The device is described as a "surgical instrument to assist" and works with "clinician approved/finalized pre-surgical plan," indicating a human-in-the-loop system. |
| 7. Type of Ground Truth Used (for Test Set) | Implied to be direct physical measurement of pin/component placement in cadaver models against the pre-operative surgical plan. (Not explicitly stated as expert consensus, pathology, or outcomes data). |
| 8. Training Set Sample Size | Not provided. The system uses "patient imaging scans, software" to create models and guides, suggesting an underlying system development that would use a training set, but its size is not mentioned. |
| 9. How Ground Truth for Training Set Was Established | Not provided. |
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AUG 0 6 2013
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | ||
|---|---|---|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell Drive | |
| Warsaw, IN 46581-0857 | ||
| Phone number | (574) 267-6639 | |
| Fax number | (574) 371-1027 | |
| Establishment | 1825034 | |
| Registration Number | ||
| Name of contact | Tracy Bickel Johnson, RAC | |
| person | ||
| Date prepared | July 25, 2013 | |
| Name of device | ||
| Trade or proprietaryname | Signature™ Personalized Patient Care System - Glenoid Guide System | |
| Common or usual | Shoulder instruments | |
| name | ||
| Classificationname | prosthesis, shoulder, semi-constrained, metal/polymer | |
| Regulation | cemented (§ 888.3660) | |
| prosthesis, shoulder, non-constrained, metal/polymer● | ||
| cemented (§ 888.3650) | ||
| prosthesis, shoulder, semi-constrained, metal/polymer + | ||
| additive, cemented (§ 888.3660) | ||
| prosthesis, shoulder, semi-constrained, metal/polymer, | ||
| uncemented (§ 888.3670) | ||
| Classification panel | Orthopedic | |
| Product Code(s) | KWS, KWT, PAO, and MBF | |
| Legally marketed device(s) to | (Reference Device) Modular Hybrid Access● | |
| which equivalence is claimed | Glenoid/Comprehensive Reverse Shoulder Instruments (Biomet, | |
| Inc.)- 510(k) Exempt | ||
| NaviPro Shoulder System (Kinamed, Inc.)- K050897● | ||
| Signature Personalized Patient Care System- Acetabular Guide | ||
| System (Materialise, NV)- K111863 | ||
| New patient specific glenoid quides | ||
| Reason for 510(k) submissionDevice description | Patient specific guides are designed and manufactured in plastic using | |
| additive manufacturing. The guides are developed using patient | ||
| imaging scans, software, and the clinician approved/finalized pre- | ||
| landmarks of the shoulder that are identifiableanatomicalon | ||
| Intended use of the deviceIndications for use | surgical plan. The guides facilitate the placement of metallic pins andcan be used in conjunction with existing anatomic and reverse Biometinstrumentation and surgical techniques.Intraoperative placement of metallic bone pins in arthroplastyprocedures.The Signature Personalized Patient Care System - GlenoidGuide System is intended to be used as a surgical instrument toassist in the positioning of glenoid components intra-operatively using | |
| preoperative imaging scans. | ||
| The Signature Personalized Patient Care System - GlenoidGuide System can be used in conjunction with the ComprehensiveTotal and Reverse Shoulder Systems (including the Modular HybridGlenoid, Bio-Modular Heads and Stems), and their respectivecomponents, which require placement of an initial center pin or holeto quide the associated system instruments.The Signature Glenoid Guide is intended for single use only. | ||
| Summary of the TechnologiesSignature™ Glenoid Guide System consists of various software systems to create patient specific glenoidquides to facilitate the orientation of the central pin for glenoid preparation. The CT patient imaging datais collected preoperatively and used to create three-dimensional "models" which are then transferred to aglenoid template resulting in a guide that can place anatomic and reverse shoulder components. | ||
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS | ||
| Performance Test Summary-New Device | ||
| Accuracy performance testing (cadaver lab) and Guide verification of post processing techniquesand autoclave sterility deformation dimensional stability testing was performed to determinesubstantial equivalence. | ||
| Planned trajectories analysis for Signature and Predicate | ||
| Packaging/Sterilization Testing | ||
| Pathologic Model Analysis | ||
| Testing verified that the accuracy and performance of the system is adequate to perform as intended. | ||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | ||
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||
| Clinical Performance Data/Information: N/A | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | ||
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The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2013
Biomet, Incorporated % Ms. Tracy Bickel Johnson Global Regulatory Project Manager 56 East Bell Drive Warsaw, Indiana 46581
Re: K130126
Trade/Device Name: Signature" Personalized Patient Care System - Glenoid Guide System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWT, KWS, PAO Dated: June 21, 2013 Received: June 24, 2013
Dear Ms. Johnson:
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
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Page 2 - Ms. Tracy Bickel Johnson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeyices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130126
Device Name: Signature™ Personalized Patient Care System - Glenoid Guide System
Indications For Use:
INDICATIONS FOR USE
The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans.
The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments.
The Signature Glenoid Guide is intended for single use only.
Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR AND/OR AND/OR AND/OR CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CANALE CONT
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”