The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads and combination of these defects.

The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic- and scaphocephalic- shaped heads.

Device Description

The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II. The Cranial Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient. The Cranial Orthosis is made according to the 3D scan of the infant´s head. The modified shape of the infant's symmetrical head shape is created in CAD software from the 3D scan. CAD model of the outer shell of the Orthosis is based on modified shape of infant's head. The outer shell of the Orthosis is produced by 3D printing. The Cranial Orthosis is assembled from two-part outer 3D printed shell and the inner soft foam layer.

AI/ML Overview

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance for a medical device that relies on AI or an algorithm. The submission is for a Cranial Orthosis (Talee, Talee PostOp), which is a physical device, not an AI-driven diagnostic or assistive tool.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this specific device submission as an AI/algorithm is not the primary component of the device being evaluated for clinical effectiveness.

The document focuses on non-clinical performance testing of the physical cranial orthosis and its manufacturing process, along with demonstrating substantial equivalence to a predicate device.

However, I can extract information related to the device's physical and material properties, and the testing conducted on those aspects, to address the spirit of the request as much as possible given the provided text.

Here's an attempt to categorize the relevant information from the document, acknowledging that it's a physical device and not an AI/algorithm:

Acceptance Criteria and Device Performance (for a Physical Cranial Orthosis)

Given that this is a 510(k) submission for a physical cranial orthosis (Talee, Talee PostOp) and not an AI/algorithm-driven device, the "acceptance criteria" and "device performance" are primarily related to its mechanical properties, manufacturing accuracy, and biocompatibility, rather than diagnostic or assistive performance metrics for an AI. The document indicates that all predetermined acceptance criteria for these tests were met.

Table of Acceptance Criteria and Reported Device Performance (Physical Device Focus)

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance / Conclusion
Biocompatibility	ISO Cytotoxicity MEM Elution (ISO 10993-5)	Results: Cell culture treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic.
	ISO Intracutaneous Irritation (ISO 10993-10)	Results: Rabbits treated with test samples exhibited no irritation (Scores 0). Conclusion: Non-irritating.
	ISO Guinea Pig Maximization Sensitization (ISO 10993-10)	Results: Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0). Conclusion: Non-sensitizer.
Mechanical Strength	Impact Strength mechanical test	The tested devices Talee and Talee PostOp have comparable safety and comparable (or higher) structural strength than the predicate/reference devices. Predetermined acceptance criteria were met.
	Structural Stiffness mechanical test	The tested devices Talee and Talee PostOp have comparable safety and comparable (or higher) structural strength than the predicate/reference devices. Predetermined acceptance criteria were met.
Manufacturing Accuracy	Accuracy Test – Manufacturing of Cranial Remolding Orthosis	All of the acceptance criteria were met, ensuring required dimensional accuracy and that the devices fit accurately. Based on the Accuracy and Capabilities study, the CCA software program met all the acceptance criteria and provides comparable accuracy to manual and CAD method.
	Manufacturing Test - Dimensional Accuracy of Laser Plotter	All of the acceptance criteria were met, ensuring required dimensional accuracy and that the devices fit accurately.
Software Functionality	Accuracy and Capabilities Study (for Cranial Comparison App - CCA)	The CCA software program met all the acceptance criteria and provides comparable accuracy to manual and CAD method. The CCA also has the same (or greater) capabilities as the manual or CAD method.

Study Details (Focusing on non-clinical performance and substantial equivalence)

Given that this is a physical medical device (Cranial Orthosis), not an AI/algorithm, many of the requested AI-specific points are not relevant. However, I will address what is present in the document.

Sample size used for the test set and the data provenance:
- The document mentions "tested devices Talee and Talee PostOp" for mechanical tests, but does not specify numerical sample sizes for these non-clinical performance tests (e.g., how many orthoses were impact tested).
- For biocompatibility, the tests describe standard animal models (rabbits, guinea pigs for irritation/sensitization) and cell cultures for cytotoxicity. No specific numerical sample sizes for these tests are provided within the document itself, but these are standard ISO methods.
- Data Provenance: The tests were conducted to support a submission to the U.S. FDA. The data provenance for the non-clinical tests would be the testing laboratories that performed them. The document refers to "non-clinical performance testing (Software, Product, Manufacturing method)." It does not discuss patient data for algorithms (as there is no AI algorithm being cleared).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of AI/algorithm ground truth. The "ground truth" for this device relates to established physical/material standards (e.g., ISO for biocompatibility, mechanical engineering standards for strength/stiffness). The specialists involved would be testing technicians and engineers, not clinical experts establishing a ground truth for a diagnostic AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no human reader "adjudication" in the context of an AI/algorithm performance study. The evaluation of non-clinical tests would follow standard laboratory quality control and reporting procedures.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, and it is not applicable. This device is a physical cranial orthosis, not an AI diagnostic or assistance tool. Therefore, there are no "human readers" whose performance is being augmented by AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a physical product. While it uses digital scanning and CAD software in its manufacturing process, the submission does not describe an AI or algorithm as a "standalone" medical device whose performance is being evaluated in this manner. The Cranial Comparison App (CCA) is mentioned as a "separate reporting software program" for measurements, but its function as a standalone diagnostic algorithm is not the focus of this submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established industry standards and regulatory requirements for medical devices, specifically:
  - Biocompatibility standards: ISO 10993 series.
  - Mechanical properties: Engineering specifications and performance metrics.
  - Manufacturing accuracy: Dimensional tolerances and verification against CAD models.
- There is no "clinical ground truth" in the sense of diagnosing a disease, as this is a treatment device.
The sample size for the training set:
- Not applicable. This device is manufactured individually based on a 3D scan of a patient's head using CAD software and 3D printing. There is no "training set" in the context of machine learning or AI algorithm development for the device itself.
- The CAD software (R4D CADCAM software) is presumably a commercial product and its "training" or development data would precede this submission.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/algorithm related to the device's efficacy. The manufacturing process relies on 3D scanning and CAD/CAM, which are established digital design and manufacturing technologies, not machine learning that requires a "ground truth" for a training set in this context.

Summary

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June 22, 2023

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.

Invent Medical USA, LLC Jiri Rosicky 1800 Mearns Rd, Suite Y Warminster, Pennsylvania 18974

Re: K230444

Trade/Device Name: Talee, Talee PostOp Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: May 22, 2023 Received: May 23, 2023

Dear Jiri Rosicky:

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 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

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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 medical devices and radiation-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,

Adam D. Pierce -S

Digitally signed by Adam D. Pierce -S Date: 2023.06.22 10:58:23 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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)

K230444

Device Name

Talee, Talee PostOp

The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

Type of Use (Select one or both, as applicable)

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

Submitter:	Invent Medical USA, LLC
Address:	1800 Mearns Rd, Suite Y, Warminster, PA 18974, USA
Phone number:	1 (267) 368-8165
Contact person:	Jiri Rosicky
Phone number:	1 (267) 368-8165
Date prepared:	June 22, 2023
Trade name:	Talee, Talee PostOp
Common name:	Cranial Orthosis
Product Code:	MVA, OAN Cranial Orthosis
Regulation:	21 CFR 882.5970, Cranial Orthosis, Class II
	Substantial equivalence claimed to predicate device: Talee, Talee PostOp (K220681)

Reference device: MyCRO Band (K201426)

Description:

Product Summary

The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II.

The Talee, Talee PostOp proposed device is identical to the existing predicate Talee, Talee PostOp cleared in K220681. There have been made the following modifications:

New optional Firm pad manufactured from the same material as outer shell (PA11, PA12 or CB PA12) with Plastazote inner layer material as skin contacting material (cleared in K220681).
Update in approved 3-dimensional imaging devices

Discussion of Design Changes and 3-dimensional imaging devices (Proposed device device K220681)

The design changes of Talee, Talee PostOp proposed device do not affect the intended use, the safety of the medical device or the effectiveness of treatment of the existing predicate Talee PostOp cleared in K220681.

. The basic product design of the Talee, Talee PostOp proposed device is identical to the product design of the existing predicate Talee, Talee PostOp (K220681).
Manufacturing process of the Talee, Talee PostOp proposed device is identical to the manufacturing process of the existing predicate Talee, Talee PostOp (K220681).
. Skin contacting material of the Talee, Talee PostOp proposed device is identical to the material of the existing predicate Talee, Talee PostOp (K220681).
The new optional Firm pad represents new choice to existing foam pads. The skin contacting material Plastazote of Firm pad is the same as skin contacting material of Foam pad used in predicate device.

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. The new approved 3D scanners work on identical principle to the previously approved devices. This update is a response to a wider device portfolio on the market.

Remolding principle

The Cranial Remolding Orthosis (Talee PostOp) has contact with the head in the prominent regions, and a precisely pre-defined internal space in the areas where flattening occurs. The skull only has the possibility to grow into that pre-defined space, which as a result improves the cranial symmetry and/or physiological shape. The same cranial remolding principle is applied to patients with positional plagiocephaly and to post-operative patients.

During treatment, the Cranial Orthosis is checked regularly by a physician/clinician to ensure proper treatment at all times. The infant is evaluated monthly by the clinician to monitor growth and ensure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis.

Manufacturing process

The Cranial Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient.

The Cranial Orthosis is made according to the 3D scan of the infant´s head. The shape of the baby's head is scanned by a non-contact optical light 3D scanner that does not have any side effects on the child's health (see the list of approved scanners in Table 3).

The modified shape of the infant's symmetrical head shape is created in CAD software (R4D CADCAM software, Rodin4D, http://rodin4d.com/en/Products/rectification) from the 3D scan.

CAD model of the outer shell of the Orthosis is based on modified shape of infant's head. The outer shell of the Orthosis is produced by 3D printing (industrial HP MJF 3D printed shell provides stiffness of the Orthosis and the control of the desired head shape.

The Cranial Orthosis is assembled from two-part outer 3D printed shell and the inner soft foam layer. Inner soft foam layer is made from polyethylene foam (Plastazote), which ensures soft contact with the skin of the child's head. The Plastazote is held in place by double sided tape. On the left/right side of the orthosis there is a fastening mechanism, which is used for easy donning/doffing of the Cranial Orthosis.

Specification of Materials

Talee - Outer shell:

3D printed perforated and contoured multi-layer shell structure from nylon (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 4mm (5/32").

Talee Inner material:
Polyethylene foam (Plastazote), thickness varies from 3mm (1/8") to 12mm (1/2")

Talee - Adjustment pads material (optional):

Oval pads - Polyethylene foam (Plastazote) thickness varies from 2mm (1/12") to 4mm (1/6")

Foam pad - Polyethylene foam (Plastazote) & Polyurethane elastic foam/ Thermoplastic polyurethane, thickness varies from 3mm (1/8") to 19mm (3/4"). Plastazote material at skin contacting side.

Firm pad - Polyamide pad made by 3D printing (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4"). Plastazote material at skin contacting side.

Talee PostOp - Outer shell:

3D printed perforated and contoured multi-layer shell structure from nylon (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4").

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Talee PostOp - Inner material: Polyethylene foam (Plastazote), thickness varies from 3mm (1/8") to 12mm (1/2") Talee PostOp – Adjustment pads material (optional): Oval pads – Polyethylene foam (Plastazote) thickness varies from 2mm (1/12") to 4mm (1/6") Foam pad - Polyethylene foam (Plastazote) & Polyurethane elastic foam/ Thermoplastic polyurethane, thickness varies from 3mm (1/8") to 19mm (3/4"). Plastazote material at skin contacting side. Firm pad - Polyamide pad made by 3D printing (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4"). Plastazote material at skin contacting side.

Talee and Talee PostOp - Fastening mechanism: Self-locking clip mechanism on left/right sides, 3D printed with BOA lanyard or Rubber band.

Product fitting, adjustments, and reporting software

The Cranial Remolding Orthosis is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician. During treatment, the Cranial Orthosis Talee and Talee PostOp is regularly checked by a physician/clinician to ensure proper treatment at all times. During an initial fitting and also at every follow up, the clinician will assess the need for further adjustments made by adding stabilization pads or removing them. All components are assembled into the finished product manually. Any assembly or adjustments are always done by a specifically trained professional.

The infant is evaluated monthly by the clinician to monitor growth and ensure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis. Cranial Comparison App (CCA) is a separate reporting software program designed to present specific measurements derived from a 3D digital model of the patient's cranium. The CCA does not affect the operation of the approved scanners (see the list of approved scanners). The CCA is not used for manufacturing of the Talee or Talee PostOp.

Indications for Use:

The Talee and the Talee PostOp are Cranial Remolding Orthoses, intended for medical purposes, for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Technological Characteristics:

The Cranial Remolding Orthoses Talee PostOp are substantially equivalent to the predicate/reference medical devices. It is a Cranial Orthosis designed individually for each patient based on a 3D scan of the baby's head. The intended use is identical - the treatment of head shape deformities at a crucial growing period of an infant's life. The remolding principle of the Cranial Orthosis is identical.

The tables below show the comparison between the Cranial Remolding Orthosis Talee PostOp and the predicate medical device features and approved 3D scanners (Table 2 below shows the comparison between the Cranial Remolding Orthosis Talee PostOp and the reference medical device, including another approved 3D scanners in previously cleared 3D printed cranial orthosis.

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Feature	Talee, Talee PostOpProposed Device	K220681Talee, Talee PostOpPredicate Device	Evaluation ofdifference
Intended Use	The Cranial Remolding Orthosis has contact with the head in prominentregions where there is contact pressure, while leaving precise, pre-defined internal spaces in areas where there is flattening. To improvecranial symmetry and/or physiological shape, the skull only has thepossibility for growth in that pre-defined space.		IDENTICAL
Materials
Talee Outer Shell:	3D printed perforated andcontoured multi-layer shellstructure from Polyamide/Nylon(PA11, PA12 or CB PA12),thickness varies from 0.8 mm(1/32") to 4 mm (5/32") withoptional water-based colorcoating.	3D printed perforated andcontoured multi-layer shellstructure from Polyamide/Nylon(PA11, PA12 or CB PA12),thickness varies from 0.8 mm(1/32") to 4 mm (5/32") withoptional water-based colorcoating.	IDENTICAL
Talee InnerMaterial:	Polyethylene foam (Plastazote)Polyethylene foam, thicknessvaries from 3 mm (1/8") to 12 mm(1/2")	Polyethylene foam (Plastazote)Polyethylene foam, thicknessvaries from 3 mm (1/8") to 12mm (1/2")	IDENTICAL
Talee PostOpOuter Shell:	3D printed perforated andcontoured multi-layer shellstructure from Polyamide/Nylon(PA11, PA12 or CB PA12),thickness varies from 0.8 mm(1/32") to 6 mm (1/4") withoptional water-based colorcoating.	3D printed perforated andcontoured multi-layer shellstructure from Polyamide/Nylon(PA11, PA12 or CB PA12),thickness varies from 0.8 mm(1/32") to 6 mm (1/4") withoptional water-based colorcoating.	IDENTICAL
Talee PostOpInner Material:	Polyethylene foam (Plastazote)Polyethylene foam, thicknessvaries from 3 mm (1/8") to 12 mm(1/2")	Polyethylene foam (Plastazote)Polyethylene foam, thicknessvaries from 3 mm (1/8") to 12mm (1/2")	IDENTICAL
Adjustment padmaterial(Talee, TaleePostOp)(optional):	Polyethylene foam (Plastazote) &Polyurethan elastic foam/TPU/PA11, PA12, CB PA12, thicknessvaries from 0.8mm (1/32") to19mm (3/4")	Polyethylene foam (Plastazote) &Polyurethan elastic foam/TPU,thickness varies from 3mm (1/8")to 19mm (3/4")	Differences ininterlayermaterials used forCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.All materials havebeen previouslyused for medicalapplications
Closure Mechanism(Talee, TaleePostOp):	Self-locking clip mechanism onleft/right sides, 3D printed clipcombined with BOA lanyard orRubber Band	Self-locking clip mechanism onleft/right sides, 3D printed clipcombined with BOA lanyard orRubber Band	IDENTICAL
Product design	The Cranial Remolding Orthoses, Talee and Talee PostOp, are madeindividually as a patient-specific device.The weight of a Talee orthosis varies from approx. 155 to 250g (5 to 8oz).Talee PostOp orthosis weight varies from approx. 215 to 370g (7 to 12oz).		IDENTICAL
Production	• The Orthosis is assembled from outer shell and inner soft foam parts.• The outer shell of the Orthosis is produced by 3D printing, based onCAD model.• CAD model is based on modified shape of infant's head.• Modified shape of infant's head in CAD software is created from thedata from 3D scanners		IDENTICAL
Approved 3-DimensionalImaging Devices	• Omega Scanner• 3dMDhead System• 3dMDflex System• M4DScan/BodyScan System• Spectra 3D Scanner• Creaform HCP• Creaform Peel 1• Creaform Peel 2 (=Peel 3D)• Artec Eva• Artec Eva Lite• Einscan H	• Omega Scanner• 3dMDhead System• 3dMDflex System• M4DScan/BodyScan System• Spectra 3D Scanner	Scanners used withproposed devicewere either foundcompatible withpredicate:K220681or reference:K201426and passed V&Vprocesses.
Testing	Non - clinical performance testing:• Impact Strength mechanical test• Structural Stiffness mechanical test• Biocompatibility evaluation - Plastazote• Accuracy Test - Manufacturing of Cranial Remolding Orthosis• Manufacturing Test - Accuracy of Laser Plotter

Table 1 - Comparison of Predicate Device including Approved Scanners cleared in K220681 to Proposed Device

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	Table 2 - Comparison of Reference Device including Approved scanners cleared in K201426 to Proposed
Device

Feature	Talee, Talee PostOpProposed Device	K201426MyCRO BandReference Device	Evaluation ofdifference
Intended Use	The Cranial Remolding Orthosishas contact with the head inprominent regions where there iscontact pressure, while leavingprecise, pre-defined internalspaces in areas where there isflattening. To improve cranialsymmetry and/or physiologicalshape, the skull only has the	Redirects head growth bymaintaining contact over cranialareas which protrude and bycreating voids over areas ofdepression or flattening in orderto improve symmetry.	IDENTICAL
	possibility for growth in that pre-
Materials	defined space.
Outer Shell:	Talee, Talee PostOp:3D printed perforated andcontoured multi-layer shellstructure from Polyamide/Nylon(PA11, PA12 or CB PA12),thickness varies from 0.8 mm(1/32") to 4 mm (5/32") withoptional water-based colorcoating.	The orthosis is made ofthermoplastic material PolyamidePA12 with a soft, washablepadded lining on the interior.	Differences in outerand inner layermaterials used forCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.
Inner Material:	Talee, Talee PostOp:Polyethylene foam (Plastazote)Polyethylene foam, thicknessvaries from 3 mm (1/8") to 12 mm(1/2")		effectiveness oftreatment.All materials havebeen previously
Adjustment padmaterial:	Talee, Talee PostOp (optional):Polyethylene foam (Plastazote) &Polyurethan elastic foam/TPU/PA11, PA12, CB PA12, thicknessvaries from 0.8mm (1/32") to19mm (3/4")	N/A	used for medicalapplications andare not expected tocause any adverseevents when incontact with skin orhair.
ClosureMechanism:	Talee, Talee PostOp:Self-locking clip mechanism onleft/right sides, 3D printed clipcombined with BOA lanyard orRubber Band	One sided 3D printed closuremechanism combined with elasticband	The mechanismsare similar.Closure mechanismof proposed devicehas been previouslyapproved inpredicate deviceK220681.
Product design	The Cranial Remolding Orthoses,Talee and Talee PostOp, are madeindividually as a patient-specificdevice.The weight of a Talee orthosisvaries from approx. 155 to 250g(5 to 8 oz).Talee PostOp orthosis weightvaries from approx. 215 to 370g(7 to 12 oz).	Polymer helmet with side openingclosure and padded lining4 – 6.5 ozPatient-matched sizing byscanning an image of patient'shead shape	Differences inproduct design of aCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.
Production	• The orthosis is assembled fromouter shell and inner soft foamparts.• The outer shell of the orthosisis produced by 3D printingbased on CAD model.• CAD model is based onmodified shape of infant'shead.	Additively manufacture theorthosis based uponmeasurements of the infant'shead taken by a previouslycleared 3-dimensional imagingdevice	IDENTICAL
	• Modified shape of infant'shead in CAD software iscreated from the data from 3Dscanners (see the list ofapproved scanners – Table 3).
Approved 3-DimensionalImaging Devices	• Omega Scanner• 3dMDhead System• 3dMDflex System• M4DScan/BodyScan System• Spectra 3D Scanner• Creaform HCP• Creaform Peel 1• Creaform Peel 2 (=Peel 3D)• Artec Eva• Artec Eva Lite• Einscan H	• Creaform HCP• Creaform Peel1• Creaform Peel 3D• Rodin4D M4D Scan• TechMed3D BodyScan• OMEGA Scanner 3D• Artec Eva• Artec Eva Lite	Scanners used withproposed deviceare either clearedby predicate:K220681or reference:K201426and passed V&Vprocesses.

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Non-clinical performance Testing:

The following Non-clinical performance testing (Table 4) was conducted on Talee PostOp Proposed Device.

Tested Area	Performance Testing
Product	Impact strength mechanical test
Talee/Talee PostOp	Structural stiffness mechanical test
Method
Manufacturing	Accuracy Test – Manufacturing of Cranial Remolding Orthosis

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Biocompatibility evaluation:

Non-clinical performance testing included biocompatibility evaluation of materials in contact with intact skin. The results of these tests are in Table 5.

Biocompatibility evaluation - PE foam (Plastazote)
Test	Results	Conclusions
ISO Cytotoxicity MEM ElutionISO 10993-5	Cell culture treated with test sample exhibitedno reactivity (Grade 0)	Non-cytotoxic
ISO Intracutaneous IrritationISO 10993-10	Rabbits treated with test samples exhibited noirritation (Scores 0)	Non-irritating
ISO Guinea Pig MaximizationSensitizationISO 10993-10	Albino guinea pigs treated with test sample didnot elicit a sensitization response (Grade 0)	Non- sensitizer
The material is in contact with the intact skin of the head. It is necessary to clean and disinfect polyethylenefoam (Plastazote) material each day by isopropyl alcohol as described in the Instructions for Use.

Table 5 - Materials in contact with intact skin
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The safety of the Cranial Orthosis is established under standard biocompatibility assessments. These assessments reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of wear. (Polyethylene foam is commonly used to line orthoses). The materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no significant threat to the child during application within the normal scope of its intended use.

Test summary and discussion:

The Talee, Talee PostOp Proposed Device is identical to the K220681 Talee, Talee PostOp Predicate Device.

The following non-clinical tests were conducted for Talee and Talee PostOp and are valid for both proposed and predicate devices. The predetermined acceptance criteria were met:

Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174) -
-Cytotoxicity testing per ISO 10993-5:2009 (Recognition Number: 2-245)
Irritation testing per ISO 10993-10:2010 (Recognition Number: 2-174) -
-Accuracy and Capabilities Study
-Impact strength mechanical test
-Structural stiffness mechanical test
-Manufacturing Test - Dimensional Accuracy of Laser Plotter
-Accuracy Test - Manufacturing of Cranial Remolding Orthosis

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Discussion

Talee, Talee PostOp Proposed device is identical to the K220681 Talee, Talee PostOp Predicate device with updates described above.

Full validation and verification (V&V) testing is not necessary for the proposed design changes. New V&V was performed to evaluate the specific design changes to ensure the changes do not alter the safety and effectiveness of the device. All these updates have passed Invent Medical's V&V processes. Overview of the non-clinical performance tests completed for the updates is in table 4.

Above in the test summary you can find an overview of tests performed for K220681 Talee, Talee PostOp predicate device and valid for Talee, Talee PostOp proposed device.

Based on the Accuracy and Capabilities study, the CCA software program met all the acceptance criteria and provides comparable accuracy to manual and CAD method. The CCA also has the same (or greater) capabilities as the manual or CAD method.

According to the mechanical tests performed, the tested devices Talee and Talee PostOp, have comparable safety and comparable (or higher) structural strength than the predicate/reference devices.

The Manufacturing test and the Accuracy test mentioned above showed that all of the acceptance criteria were met and the manufacturing process of the finished 3D printed cranial remolding orthosis ensures the required dimensional accuracy and that the devices fit accurately.

The Biocompatibility assessments included in the non-clinical performance testing of the materials in contact with intact skin revealed that these materials used are not expected to have adverse effects on the patients under the intended conditions of wear.

Conclusions of non-clinical performance data

The non-clinical performance testing mentioned above demonstrates that the differences in production of Cranial Orthosis do not affect performance, safety, or effectiveness of Medical Device Talee PostOp in comparison to K220681 Talee, Talee PostOp predicate device.

We tested Talee, Talee PostOp proposed device compared to the same tested reference device (STARband, STARlight PRO) that we used for performance testing of K220681 Talee, Talee PostOp predicate device.

All the results of this performance testing demonstrate identical conclusions as results of performance testing of cleared Predicate device Talee PostOp to the same tested reference device (STARband, STARlight PRO).

Substantial equivalence, safety and effectiveness are supported by Non-clinical Performance Testing (Software, Product, Manufacturing method) of Talee PostOp to primary predicate device (K220681 Talee, Talee PostOp).

General conclusion:

Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the subject device Talee/Talee PostOp is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.

Regulation Number and Section

§ 882.5970 Cranial orthosis.

(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).