The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

Device Description

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Soteira Shield Kyphoplasty System, a device for vertebral augmentation. The information focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria with specific acceptance thresholds for device performance.

Therefore, the concept of "acceptance criteria" as applied to a new AI/software device with quantitative performance metrics (e.g., accuracy, sensitivity, specificity) and a "reported device performance" against those criteria is not directly applicable here. The equivalence is demonstrated through comparative studies against established predicate devices.

However, based on the provided text, we can infer the "acceptance criteria" and "reported device performance" in terms of how the Soteira Shield Kyphoplasty System compares to its chosen predicate device (vertebroplasty) across various aspects.

Here's an interpretation of the request using the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are typically centered around demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. Quantifiable performance metrics against predefined thresholds, as seen in AI/software device evaluations, are not explicitly stated. Instead, the performance is assessed relative to the predicate.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Soteira Shield Kyphoplasty System)
Mechanical Equivalence: Demonstrate equivalent static and cyclic mechanical behavior.	"The Soteira Shield Kyphoplasty System demonstrated equivalent behavior under both test conditions." (Cadaveric bench testing)
Biocompatibility: Demonstrate biocompatibility in accordance with ISO 10993.	"Biocompatibility testing was performed in accordance with ISO 10993... demonstrated the combination of the Soteira Shield implant and PMMA bone cement is biocompatible."
MRI Compatibility: Determine "MR-conditional" status per ASTM F2503-05.	"The implant and bone cement have been tested for MRI compatibility and have been determined to be 'MR-conditional' in accordance with the ASTM standard F2503-05."
Pain and Functional Improvement: Demonstrate equivalent initial and sustained benefits compared to vertebroplasty.	"Pain and functional testing demonstrated equivalent initial improvements and sustained benefits out to one year" compared to the control device (vertebroplasty).
Asymptomatic Leakage Rate: Demonstrate a non-inferior (or better) rate of asymptomatic leaks compared to vertebroplasty.	"The Soteira Shield Kyphoplasty System showed less assymptomatic leaks than the control (vertebroplasty)."
Adverse Events Profile: Demonstrate a comparable (or better) safety profile.	Both the Soteira device and the control exhibited similar types of adverse events (death, adjacent/distant fractures, refracture). Incomplete filling and retreatment were specific to Soteira (not explicitly stated for control).

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

The clinical study served as the primary "test set" for equivalence demonstration.

Sample Size for Test Set:
- Soteira Shield Kyphoplasty System: 69 subjects and 102 levels.
- Control Device (Vertebroplasty): 28 subjects and 38 levels.
Data Provenance: The study was a "prospective randomized study." The country of origin is not specified but implicitly within the US regulatory context (indicated by FDA 510(k) submission).

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

The text does not mention the use of experts to establish a "ground truth" in the diagnostic sense, as this is a medical device for treatment. The "ground truth" for the clinical study would be derived from clinical outcomes, patient-reported pain scores, functional assessments, and imaging assessments of cement leakage. The study's design (prospective, randomized) implies that standard clinical methodologies and assessments were used, likely carried out by treating physicians and study staff, but specific numbers and qualifications of "experts" for ground truth establishment are not provided.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for the test set data. In a prospective clinical trial like this, data collection and assessment would follow a pre-defined protocol, and outcomes (pain, function, adverse events, leakage) would be recorded. Any discrepancies in data recording or interpretation would typically be handled through standard clinical trial monitoring and data management processes, but a specific "adjudication method" beyond standard clinical practice is not detailed.

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

This is not applicable. The study is for a physical medical device (Kyphoplasty System) for treating vertebral fractures, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.

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

This is not applicable. The device is a surgical system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was based on:

Clinical Outcomes: Patient-reported pain levels, functional scores, and recorded adverse events.
Imaging Data: Assessment of cement leakage.
Medical Diagnosis: Diagnosis of osteoporotic compression fractures requiring intervention.

8. The Sample Size for the Training Set

This is not applicable. The Soteira Shield Kyphoplasty System is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "pilot study" mentioned could be considered an early phase of clinical data collection that might inform the design of the larger prospective study, but it doesn't function as a "training set" for an algorithm.

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

This is not applicable, as there is no "training set" in the context of an algorithmic device.

Summary

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510(k) Summary

DEC - 8 2011

Owner's Name:	Soteira, Inc.
Address:	14 Tech CircleNatick, MA 01760
Telephone Number:	(508) 651-2611
Fax Number:	(508) 651-3611
Contact Person:	John V. Hamilton, Director of Spinal Programs
Subject Device Name:	Shield Kyphoplasty System
Trade Name:	Shield Kyphoplasty System
Classification Name:	Polymethylmethacrylate (PMMA) Bone Cement
Product Code:	NDN
Regulation:	21 CFR 888.3027
Device Classification:	Class II device
Predicate Devices:	Stryker SpinePlex™ Bone Cement (K032945)Kyphon Kyphx® Inflatable Bone Tamp (K041454

Device Description

Indications for Use

Performance Testing

Pre-clinical testing included cadaveric bench testing, biocompatibility and MRI compatibility. The cadaveric bench tests consisted of static and cyclic mechanical testing of osteoporotic vertebral bodies treated with the Soteira Shield Kyphoplasty System and vertebroplasty. The Soteira Shield Kyphoplasty System demonstrated equivalent behavior under both test conditions. Biocompatibility testing was performed in accordance with ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing demonstrated the combination of the Soteira Shield implant and PMMA bone cement is biocompatible. The implant and bone cement have been tested for MRI compatibility and have been determined to be "MR-conditional" in accordance with the ASTM standard F2503-05 Standard Practice for Marking Medical Devices and Other Item for Safety in the Magnetic Resonance Environment.

Clinical testing consisted of a pilot study and a prospective randomized study using vertebroplasty as the control device. All subjects were diagnosed with osteoporotic compression fractures that had undergone conservative care for a minimum of 6 weeks or had

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been hospitalized for pain. A total of 69 subjects and 102 levels were treated with the Soteira Shield Kyphoplasty System and 28 subjects and 38 levels were treated with the control device. Pain and functional testing demonstrated equivalent initial improvements and sustained benefits out to one year. The Soteira Shield Kyphoplasty System showed less assymptomatic leaks than the control (vertebroplasty). For the Soteira device adverse events included ; death, adjacent and distant level fractures, incomplete filling, refracture and retreatment of the treated levels while the control exhibited; death, adjacent and distant level fractures,and , refracture of a treated level

Conclusion

The Soteira Shield Kyphoplasty System has been demonstrated, through labeling, descriptive characteristics and performance testing data, to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three parallel lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Soteria, Inc. % Delphi Medical Device Consulting, Inc. Ms. Pamela Papineau 5 Whitcomb Avenue Ayer, Massachusetts 01432

DEC 0 8 2011

Re: K093477

Trade/Device Name: Shield Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: September 15, 2011 Received: October 24, 2011

Dear Ms. Papineau:

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

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Page 2 - Ms. Pamela Papineau

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Resources/or You/Industry/default.htm.

Sincerely yours,

F-R

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K093477

Device Name:

Shield Kyphoplasty System

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093477

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”