(193 days)
MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.
The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identical to the other Medacta MySpine products, the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System (K12115, K132878, K141988, K153664, K162061, and K171170). Specifically, the subject MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
The provided text describes a medical device, the "MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides," and its substantial equivalence determination by the FDA. However, the document does NOT contain information about specific acceptance criteria for a device's performance (like sensitivity, specificity, accuracy, etc.) nor does it usually detail specific studies that prove the device meets such criteria in terms of quantitative metrics suitable for the requested table.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics (manufacturing process, material, biocompatibility, device usage, sterility, shelf life, packaging) and performance data from non-clinical studies (software validation, cadaver testing, guide accuracy, stability assessment). The "guide accuracy" mentioned is a general category and not a specific set of acceptance criteria with reported performance.
Therefore, I cannot fill in the table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, expert qualifications, or ground truth establishment for a standalone algorithm performance study, because this information is not present in the provided text. The document explicitly states: "No clinical studies were conducted." and it does not describe an AI algorithm with human-in-the-loop performance.
Here's an overview of what can be extracted or inferred based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated with quantifiable metrics (e.g., "accuracy must be > 95%"). The document talks about "software validation," "cadaver testing," "guide accuracy," and "stability assessment" as general categories of testing performed, aiming to show safety and effectiveness comparable to the predicate.
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy percentages, error margins) are reported in the document.
Therefore, this table cannot be filled based on the provided input.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "Cadaver testing" and "Guide accuracy" testing, but no details on the number of cadavers or cases used for these tests are provided.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no detailed test set and ground truth establishment methodology is described in the provided text. The document refers to "surgical planning software" that "pre-operatively plans the positions of the components based upon radiological images," but this is part of the device's function, not a ground truth establishment for an AI algorithm's performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no detailed test set and ground truth establishment methodology is described.
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. The document explicitly states: "No clinical studies were conducted." The device (surgical guides) assists surgeons, but the documentation does not describe a study involving human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a physical surgical guide produced using software, not a standalone AI algorithm that provides diagnostic or prognostic outputs. The "MySpine software platform" is integral to creating the guides. "Software validation" was performed, but no standalone algorithm performance as typically understood in AI/ML context (e.g., measuring diagnostic accuracy against ground truth without human intervention) is described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated for any performance evaluation in terms of AI. For the device itself and its intended use, the anatomical landmarks from patient CT scans and selected surgical equipment (per planning software) would form the basis for the design of the patient-specific guides. The "guide accuracy" testing would presumably involve comparing the guide's output (screw trajectory) against the planned trajectory or anatomical reality, but the specific ground truth methodology for this testing is not detailed.
8. The sample size for the training set
- Not applicable. The document describes a medical device (surgical guides) and the software that creates them for individual patients. It does not refer to a machine learning model that requires a "training set" in the conventional sense for AI performance. The software uses patient-specific CT data for planning.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a "training set" for an AI model.
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October 5, 2020
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International SA % Mr. Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200792
Trade/Device Name: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: PQC Dated: September 8, 2020 Received: September 9, 2020
Dear Mr. Lussier:
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,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200792
Device Name
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
Indications for Use (Describe)
MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Illum. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.
Type of Use (Select one or both, as applicable)
| Beneficial Use (Part 31, GER 331, Subpart D) |
|---|
| On-Site Corrective Use (31 GER 331, Subpart E) |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: March 25, 2020
II. Device
| Device Proprietary Name: | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides |
|---|---|
| Common or Usual Name: | Pedicle Screw Placement Guide |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Primary Product Code: | PQC |
| Regulation Number: | 21 CFR 888.3070 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- A MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments, K173472, Medacta Interational SA (Primary Predicate)
IV. Device Description
The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identical to the other Medacta MySpine products, the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System (K12115, K132878, K141988, K153664, K162061, and K171170). Specifically, the subject MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium.
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The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy.
The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
V. Indications for Use
MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium.
The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected.
MySpine guides are intended for single use only.
VI. Comparison of Technological Characteristics
The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides and the predicate MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments (K173472) share the following characteristics:
- manufacturing process; .
- material; ●
- biocompatibility;
- device usage;
- sterility;
- shelf life; and
- packaging.
The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides differs from the predicate device, MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments (K173472), with regards to the following characteristics:
- body region of use; ●
- design; and ●
- anchoring point.
Discussion
The slight differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Medacta International SA has not made any changes to the intended use,
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manufacturing process, material, device usage, biocompatibility, shelf life, and packaging of the subject devices respect to the predicate devices.
The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject design, and supports the substantial equivalence of the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides to the identified predicate devices.
Performance Data VII.
Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- · Software validation
- · Cadaver testing;
- · Guide accuracy;
- · Stability assessment.
Biocompatibility data and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the MySpine S2-Alan/Alar-Iliac Pedicle Screw Placement Guides are as safe and effective as the predicate devices. Therefore, it is concluded that the MySpine S2-Alan/Alar-Iliac Pedicle Screw Placement Guides are substantially equivalent to the predicate device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.