(246 days)
Not Found
Yes
The document explicitly mentions the development, training, testing, and external validation of "ML models" incorporated into the device, and provides details on the datasets used for these processes.
No
The device is described as a "decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures". It does not directly provide therapy or treatment.
No
The device is a pre-operative planning and decision support tool for healthcare professionals. Its purpose is to assist in planning surgical procedures based on patient imaging studies, not to diagnose a condition itself. The input states, "The patient target group is adult patients who have an injury or disability diagnosed previously," which indicates diagnosis is prior to using this device.
Yes
The device description explicitly states "Being software it does not interact with any part of the body of the user and/or patient." and the intended use describes a system for pre-operative planning based on imported imaging studies, which is a software-based function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The description clearly states that PeekMed web is a system for pre-operative planning based on medical imaging studies. It works with digital representations of surgical materials and helps healthcare professionals plan surgical procedures. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to assist healthcare professionals in pre-operative planning for surgical procedures using medical imaging. This is a planning and decision support tool, not a diagnostic test performed on biological samples.
The device is a medical device, specifically a software medical device, but its function falls under surgical planning and decision support, not in vitro diagnostics.
No
The input explicitly states "Control Plan Authorized (PCCP): Not Found", which directly contradicts the conditions for a 'Yes' answer.
Intended Use / Indications for Use
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
Product codes
LLZ, QIH
Device Description
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
medical imaging
Anatomical Site
Hip, Knee, Upper limb, Foot
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare Professionals. The typical use environment is a room with a computer.
Description of the training set, sample size, data source, and annotation protocol
ML models were developed with datasets from multiple sites in a total of 2852 CR datasets, and 1903 CT scans. We trained the ML models with 80% of the datasets.
This comprehensive dataset was designed to cover the intended use population while ensuring a variety of data maintaining diverse patient characteristics.
Datasets were divided according to the subgroups listed below:
- Demographics .
- Patient Sex
- Patient Age
- Equipment and Protocols for Image Collection .
- Institution Name O
- Manufacturer O
- Manufacturer Model Name O
Description of the test set, sample size, data source, and annotation protocol
ML models were developed with datasets from multiple sites in a total of 2852 CR datasets, and 1903 CT scans. We developed with 10% and tested with the remaining 10% of the datasets. External validation is performed by sample size with a total unique dataset, for segmentation ML model: 367; Landmarking ML model: 367; and Classification ML model: 367.
External validation datasets were collected independently of the development data to prevent bias, ensuring the reliability of the results. For the external validation, a fully independent dataset, labeled by a separate team, was employed to provide an accurate assessment of the model's performance, over the whole population and for each sub-group mentioned before in order to prove that it generalizes well to unseen, real-world data. All the testing and external validation performed indicate acceptable performances of the ML models for its intended population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance testing performed on the subject device, PeekMed web, supports substantial equivalence to the predicate device.
A. Verification activities to ensure that features were implemented following the requirements and covering the acceptance criteria.
B. ML models incorporated into PeekMed web were also developed, trained, tested, and externally validated for their performance according to the internal procedures.
A dedicated validation dataset containing different data from the ML development dataset was used. Specifically, the validation dataset was not a sampling of the development dataset, has never been used for the algorithm training or for tunning the algorithm, and leakage between development and validation data sets did not occur.
C. Validation tests were performed internally before the release to the market by qualified personnel, in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the TestRail.
Nonclinical performance testing allowed us to understand that there are no related problems in the subject device. Furthermore, these tests will be repeated and updated when appropriate to ensure that the software is always properly validated, making it possible to understand in which version the problems arise and in which they are solved. Consequently, any problem that may appear in a given PeekMed web version will be identified and can be solved in subsequent versions, as all steps are traceable. All anatomical areas were tested, as well as other main areas of the software, such as the planning final report, and saved planning, ML models, among others.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The acceptance criteria for each ML model are shown in the following table:
| ML model | Acceptance Criteria |
|---|---|
| Segmentation | DICE is no less than 90% |
| HD-95 is no more than 8 | |
| STD DICE is between +/- 10% | |
| Precision is more than 85% | |
| Recall is more than 90% | |
| Landmarking | MRE is no more than 7mm |
| STD MRE is between +/- 5mm | |
| Classification | Accuracy is no less than 90%. |
| Precision is no less than 85% | |
| Recall is no less than 90% | |
| F1 score is no less than 90% |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Peek Health, S.A. Sara Silva Chief Quality Officer (CQO) Centro de Negócios Ideia Atlântico, Rua Padres Carmelitas Braga, 4719-005 Portugal
Re: K240926
December 6, 2024
Trade/Device Name: PeekMed web Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, QIH Dated: November 1, 2024 Received: November 1, 2024
Dear Sara Silva:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.cfm identifies combination product submissions. The general controls 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-report-medicaldevice-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240926
Device Name PeekMed web
Indications for Use (Describe)
PeekMed web is a system designed to help healthcare professionals carvy out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
| 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/1 description: The image shows the text 'K240926' at the top, followed by a logo in the center. The logo is a stylized, geometric shape in blue, resembling a stylized eye. Below the logo, the text 'PeekMed' is written in a simple, sans-serif font, also in blue. The logo and text likely represent the brand or company named PeekMed.
510(k) summary / K240926
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
Peek Health, S.A. Centro de Negócios Ideia Atlântico Rua Padres Carmelitas 4719-005 Braga Portugal
| Contact Person: | Sara Silva |
|---|---|
| Chief Quality Officer (CQO) | |
| Email: sara.silva@peekmed.com | |
| Office number: + 351 253 128 941 |
Date Summary Prepared: December 5, 2024
2. Device
2.1 PeekMed web
| Trade Name: | PeekMed web |
|---|---|
| Common or Usual Name: | Medical image management and processing system |
| Classification Name: | System, Image Processing, Radiological |
| (21 C.F.R. § 892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | LLZ/QIH |
3. Legally Marketed Predicate Device
3.1 PeekMed web
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K222767 | PeekMed web | December 2022 |
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Image /page/4/Picture/1 description: The image features the logo for PeekMed, a medical technology company. The logo consists of a stylized, three-dimensional shape in a teal color, resembling a cube with a section cut out to form a stylized eye. Below the graphic is the company name, "PeekMed," also in teal, presented in a clean, sans-serif typeface.
4. Device Description Summary
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
5. Intended Use/Indications for Use
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surqical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning.
The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
5.1. Contraindications
No contraindications specific to this device.
5.2 Indications for Use Comparison
There are NO differences between the indications for use of this device and its predicate.
6. Technological Comparison to Predicate
PeekMed was compared to its respective predicate device in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent. Any
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Image /page/5/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, three-dimensional cube shape in a teal color. Within the cube, there is a white outline of an eye. Below the cube, the word "PeekMed" is written in a simple, sans-serif font, also in teal.
technological differences within this 510(k), between the subject device and the predicate device, do not impact substantial equivalence, or safety and effectiveness.
The subject device and its predicate are both medical software that allows healthcare professionals to perform orthopedic pre-surgical planning efficiently in the musculoskeletal system of adults in a healthcare environment, therefore sharing the same intended use, and intended patient population. To properly and fully use both devices, clinical judgment, and experience are mandatory.
Both devices have the same workflows, use requirements (e.g., internet connection, output validation), and planning features (e.g., model representation, digital overlap of prosthetic material, possible 2D and 3D environments). Both devices generate a final report of the planning which consists of the selected images with templates, measurements, and textual information describing the patient and/or the surgical procedure to be performed.
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Image /page/6/Picture/1 description: The image shows the logo for PeekMed. The logo is a stylized, geometric shape in blue, resembling a cube or a stylized letter 'P'. Within the shape, there is a white eye symbol, suggesting a focus on vision or medical imaging. Below the shape, the word "PeekMed" is written in a simple, sans-serif font, also in blue.
Table 1: Summary of Predicate and Subject Device Characteristics to Demonstrate Substantial Equivalence
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ, QIH | LLZ, QIH | Yes | -- |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Yes | -- |
| Regulation Name | Medical Image Management And
Processing System | Medical Image Management And
Processing System | Yes | -- |
| Intended use | PeekMed web is a system
designed to help healthcare
professionals carry out
pre-operative planning for several
surgical procedures, based on
their imported patients' imaging
studies. Experience in usage and
a clinical assessment is necessary
for the proper use of the system in
the revision and approval of the
output of the planning. The
multi-platform system works with a
database of digital representations
related to surgical materials
supplied by their manufacturers. | PeekMed web is a system
designed to help healthcare
professionals carry out
pre-operative planning for several
surgical procedures, based on
their imported patients' imaging
studies. Experience in usage and
a clinical assessment is necessary
for the proper use of the system in
the revision and approval of the
output of the planning. The
multi-platform system works with a
database of digital representations
related to surgical materials
supplied by their manufacturers. | Yes | -- |
| Indications for | This medical device consists of a | This medical device consists of a | Yes | -- |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| use | decision support tool for qualified
healthcare professionals to quickly
and efficiently perform the
pre-operative planning for several
surgical procedures, using medical
imaging with the additional
capability of planning the 2D or 3D
environment. The system is
designed for the medical
specialties within surgery and no
specific use environment is
mandatory, whereas the typical
use environment is a room with a
computer. The patient target group
is adult patients who have an
injury or disability diagnosed
previously. There are no other
considerations for the intended
patient population. | decision support tool for qualified
healthcare professionals to quickly
and efficiently perform the
pre-operative planning for several
surgical procedures, using medical
imaging with the additional
capability of planning the 2D or 3D
environment. The system is
designed for the medical
specialties within surgery and no
specific use environment is
mandatory, whereas the typical
use environment is a room with a
computer. The patient target group
is adult patients who have an
injury or disability diagnosed
previously. There are no other
considerations for the intended
patient population. | | |
| Contraindications | No contraindications specific to
this device. | No contraindications specific to
this device. | Yes | --- |
| Clinical purpose | PeekMed web allows the surgeon
to perform orthopedic pre-surgical
planning efficiently in the | PeekMed web allows the surgeon
to perform orthopedic pre-surgical
planning efficiently in the | Yes | --- |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| | musculoskeletal system (e.g., Hip
procedures, Knee procedures) | musculoskeletal system (e.g., Hip
procedures, Knee procedures) | | |
| Anatomical
regions | PeekMed web allows the surgeon
to perform the pre-surgical
planning efficiently in the following
anatomical regions:
- Hip
- Knee
- Upper limb | PeekMed web allows the surgeon
to perform the pre-surgical
planning efficiently in the following
anatomical regions: - Hip
- Knee
- Upper limb
- Foot | Yes
The subject
device also
allows the
planning of
orthopedic
surgery in the
foot region. | The subject device allows for the surgery
planning on one more anatomical region
(foot), this does not constitute a new
intended purpose nor does it raise
questions of safety and performance,
since the development, verification,
validation, and release processes are
exactly the same between the devices.
The new variants of the ML model for foot
are considered in this Traditional 510(k)
and were developed according to what is
defined for each ML model development
and validation according to their intended
requirements and performance.
This change improves the medical device
in a way that the user can benefit from the
existing features on one more anatomical
region. This change does not interfere
with or create an effect on other
anatomical regions covered by the device. |
| Patient Population Adults | | Adults | Yes | --- |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| End users | Healthcare Professionals | Healthcare Professionals | Yes | --- |
| Device availability | Software is cloud-based (not
installable) and can be displayed
on any personal device or
workstation that can run on a web
browser | Software is cloud-based (not
installable) and can be displayed
on any personal device or
workstation that can run on a web
browser | Yes | --- |
| Software
Architecture | Distributed system (cloud-based).
This distributed system is a
combination of software modules
placed on servers that are able to
communicate with each other. | Distributed system (cloud-based).
This distributed system is a
combination of software modules
placed on servers that are able to
communicate with each other. | Yes | --- |
| Workflow | The workflow is as follows: Import
case images, configure images,
identify the case, pre-surgical
planning, and export the case. The
workflow chart is in Annex 2. | The workflow is as follows: Import
case images, configure images,
identify the case, pre-surgical
planning, and export the case. The
workflow chart is in Annex 2. | Yes | --- |
| Internet
connection | Required | Required | Yes | --- |
| Images source | Receives medical images from
various sources | Receives medical images from
various sources | Yes | --- |
| Data processing | The software processes data to
provide an overlap and | The software processes data to
provide an overlap and | Yes | --- |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| | dimensioning of digital
representations of the prosthetic
material | dimensioning of digital
representations of the prosthetic
material | | |
| Digital overlap of
templates | Allows the overlap of models and
the intersection of the models | Allows the overlap of models and
the intersection of the models | Yes | --- |
| Interactive model
positioning | Yes | Yes | Yes | --- |
| Interactive model
dimensioning | Yes | Yes | Yes | --- |
| Model rotation | Yes | Yes | Yes | --- |
| Support for digital
prosthetic
materials
provided by the
manufacturers | Yes | Yes | Yes | --- |
| Pre-surgical
planning | Yes | Yes | Yes | --- |
| Type of
pre-surgical
planning | Automatic or Manual | Automatic or Manual | Yes | --- |
| Contact with the
patient | No | No | Yes | --- |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| Control of life
supporting
devices | No | No | Yes -- | -- |
| Human
intervention for
image
interpretation | Yes | Yes | Yes -- | -- |
| Ability to add
additional
modules when
available | Yes | Yes | Yes -- | -- |
| Automatic bone
segmentation | Yes | Yes | Yes
The updated
ML model
variants were
compared
against the
acceptance
criteria and,
therefore
confirmed to
be an
improvement | The subject device includes new and
updated ML model variants for the
purpose of bone segmentation. These ML
model variants were developed and
validated using the same methods and
acceptance criteria and deemed as
Compliant. The updated model variants
were also compared against the
acceptance criteria, therefore confirmed to
be an improvement over the last ML
model variants versions. |
| Characteristic | PeekMed web
Predicate device K222767 | PeekMed web
Subject device | Substantially
Equivalent? | Justification and rationale |
| | | | over the last
ML model
variants
versions. | |
| Configuration
Windows for
Oblique Planes
functionality | Yes | Yes | --- | |
| Type of
landmarking | Automatic or Manual | Automatic or Manual | Yes
The updated
ML model
variants were
compared
against the
acceptance
criteria and,
therefore
confirmed to
be an
improvement
over the last
ML model
variants
versions. | The subject device includes new and
updated ML model variants for the
purpose of landmarking. These ML model
variants were developed and validated
using the same methods and acceptance
criteria and deemed as Compliant. The
updated model variants were also
compared against the acceptance criteria,
therefore confirmed to be an improvement
over the last ML model variants versions. |
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Peek Health, S.A. 510(k) Summary Traditional 510(k) Premarket Notification PeekMed web
Image /page/7/Picture/1 description: The image shows the logo for PeekMed. The logo is a blue, stylized cube with a white eye in the center. Below the cube is the text "PeekMed" in a simple, sans-serif font. The logo is clean and modern, suggesting a focus on technology and vision.
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Image /page/8/Picture/1 description: The image shows the logo for PeekMed. The logo is a blue, stylized cube with a white eye in the center. Below the cube is the text "PeekMed" in a sans-serif font. The logo is simple and modern, and the eye in the cube suggests that the company is involved in vision or medical technology.
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Image /page/9/Picture/1 description: The image shows the logo for PeekMed. The logo is a blue, stylized cube with a white eye in the center. The word "PeekMed" is written in blue below the cube. The logo is simple and modern.
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Image /page/10/Picture/1 description: The image contains the logo for PeekMed. The logo features a stylized, teal-colored geometric shape resembling a cube with a cutout in the form of the letter 'P'. Within the cutout, there is an eye symbol. Below the geometric shape, the word "PeekMed" is written in a simple, sans-serif font, also in teal.
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Image /page/11/Picture/1 description: The image shows the logo for PeekMed. The logo is a blue, stylized eye inside of a geometric shape. The text "PeekMed" is written in a sans-serif font below the logo.
12
Image /page/12/Picture/1 description: The image shows the logo for PeekMed. The logo is a stylized blue eye inside of a geometric shape. The text "PeekMed" is written in a sans-serif font below the logo.
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Image /page/13/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, teal-colored geometric shape resembling a cube with a cutout in the form of a 'P'. Within the cutout, there is an eye symbol. Below the geometric shape, the word "PeekMed" is written in a simple, sans-serif font, also in teal.
PeekMed web shares the same intended use, indications for use, end has patient population, and overall technical and functional capabilities, and therefore is substant to the predicate device. The subject device has the same design and function as the predicate device for the modes of operation and use. The subject device includes newimproved ML models and variants.
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Image /page/14/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, teal-colored geometric shape resembling a cube with a cutout in the center. Within the cutout, there is a white eye symbol. Below the geometric shape, the text "PeekMed" is written in a simple, sans-serif font, also in teal.
7. Performance Data
Nonclinical performance testing performed on the subject device, PeekMed web, supports substantial equivalence to the predicate device. The following testing was performed on the subject device:
- A. Verification activities to ensure that features were implemented following the requirements and covering the acceptance criteria.
- B. ML models incorporated into PeekMed web were also developed, trained, tested, and externally validated for their performance according to the internal procedures.
- o A dedicated validation dataset containing different data from the ML development dataset was used. Specifically, the validation dataset was not a sampling of the development dataset, has never been used for the algorithm training or for tunning the algorithm, and leakage between development and validation data sets did not occur.
Training, development, testing and external validation data information
ML models were developed with datasets from multiple sites in a total of 2852 CR datasets, and 1903 CT scans. We trained the ML models with 80% of the datasets, developed with 10%, and tested with the remaining 10%. External validation is performed by sample size with a total unique dataset, for segmentation ML model: 367; Landmarking ML model: 367; and Classification ML model: 367. This comprehensive dataset was designed to cover the intended use population while ensuring a variety of data maintaining diverse patient characteristics.
Subgroup definition (generalizability)
Datasets were divided according to the subgroups listed below:
- Demographics .
- o Patient Sex
- o Patient Age
- Equipment and Protocols for Image Collection .
- Institution Name O
- Manufacturer O
- Manufacturer Model Name O
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Image /page/15/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized eye within a geometric shape, rendered in a teal color. Below the graphic is the word "PeekMed" in a simple, sans-serif font, also in teal.
Acceptance criteria
The acceptance criteria for each ML model are shown in the following table:
| ML model | Acceptance Criteria |
|---|---|
| Segmentation | DICE is no less than 90% |
| HD-95 is no more than 8 | |
| STD DICE is between +/- 10% | |
| Precision is more than 85% | |
| Recall is more than 90% | |
| Landmarking | MRE is no more than 7mm |
| STD MRE is between +/- 5mm | |
| Classification | Accuracy is no less than 90%. |
| Precision is no less than 85% | |
| Recall is no less than 90% | |
| F1 score is no less than 90% |
Reference Standard ("Truthing" Process)
Comparison of the efficacy results of the Bone Segmentation ML model using the testing and external validation datasets against the predefined ground truth met the acceptance criteria for ML model performance, demonstrating the substantial equivalence of the subject device to its predicate.
Comparison of the efficacy results of the Landmarking ML model using the testing and external validation datasets against the predefined ground truth met the acceptance criteria for ML model performance, demonstrating the substantial equivalence of the subject device to its predicate.
Comparison of the efficacy results of the Classification ML model using the testing and external validation datasets against the predefined ground truth met the acceptance criteria for ML model performance, demonstrating the substantial equivalence of the subject device to its predicate.
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Image /page/16/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized eye within a geometric shape, rendered in a teal color. Below the graphic is the word "PeekMed" in a simple, sans-serif font, also in teal.
Independence of Training and External Validation Data
External validation datasets were collected independently of the development data to prevent bias, ensuring the reliability of the results. For the external validation, a fully independent dataset, labeled by a separate team, was employed to provide an accurate assessment of the model's performance, over the whole population and for each sub-group mentioned before in order to prove that it generalizes well to unseen, real-world data. All the testing and external validation performed indicate acceptable performances of the ML models for its intended population.
- C. Validation tests were performed internally before the release to the market by qualified personnel, in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the TestRail.
Nonclinical performance testing allowed us to understand that there are no related problems in the subject device. Furthermore, these tests will be repeated and updated when appropriate to ensure that the software is always properly validated, making it possible to understand in which version the problems arise and in which they are solved. Consequently, any problem that may appear in a given PeekMed web version will be identified and can be solved in subsequent versions, as all steps are traceable. All anatomical areas were tested, as well as other main areas of the software, such as the planning final report, and saved planning, ML models, among others.
After these successful validation tests, it is possible to deem the subject device, PeekMed web, as substantially equivalent to its predicate device.
9. Conclusion
Based on the information provided in this 510(k) submission, it was determined that the subject device, PeekMed web, is substantially equivalent to the legally marketed predicate device concerning indications for use, intended use, design, technology, and performance.