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The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.

An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the OsteoFab Patient Specific Cranial Device (K180064), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: "Worst-case, representative cranial cases were selected for end-to-end simulation testing." The document does not specify a numerical sample size for the test set (number of cases/implants tested).
• Data Provenance: The study was a "bench test" simulation. The specific country of origin for the "worst-case, representative cranial cases" or skull models is not mentioned. It is a prospective test, as it was conducted to demonstrate the device's performance for this specific 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document does not mention the use of experts to establish ground truth for the bench testing. The "acceptance criteria included meeting existing product release criteria, successful shipment... successful fixation... and satisfactory fit." This suggests a set of objective, measurable criteria rather than expert consensus on subjective aspects.

4. Adjudication method for the test set

• Adjudication methods like 2+1 or 3+1 (typically used for expert reviews) are not applicable here, as expert ground truth establishment is not described for the bench test. The acceptance was based on meeting predefined objective criteria.

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

• No, an MRMC comparative effectiveness study involving human readers or AI assistance was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This question is not applicable to the OsteoFab Patient Specific Cranial Device. It is a physical medical device, not an algorithm. The "design process" does use computer-aided design, but the "performance" discussed is related to the physical fit and functionality of the implant, not an algorithm's classification accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the bench testing was based on pre-defined, objective engineering and fit criteria ("existing product release criteria, successful shipment without damage, successful fixation, and satisfactory fit"). It's a form of objective performance criteria met in a simulated environment, rather than clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• The concept of a "training set" is not applicable in the context of this device's performance testing. This device is a custom-manufactured implant based on patient-specific CT data and a cleared manufacturing process, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

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The OsteoFab™ Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton.

An OsteoFab™ Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. The OPSCD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. The OPSCD is built by a LASER sintering machine. The OPSCD is attached to native bone with commercially available cranioplasty fixation systems. The OPSCD is a non-load bearing single use device and it is non-sterilization instructions documented in the package insert have been validated.

This document describes the performance testing conducted for the OsteoFab™ Patient Specific Cranial Device (OPSCD). The study focuses on bench testing to establish quality control specifications and demonstrate the device's material properties meet specified acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against final QC specifications derived from 23 builds, and for different thicknesses.

Summary Statistics of 23 Builds (TABLE 1):

Tensile Strength Data for Different Thicknesses (TABLE 2 - compared to 3.2 mm Release Criteria):

Through Hole Size and Spacing Measurements (TABLE 3 & 4):

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

• For final QC specifications (TABLE 1): The test set was derived from 23 builds. No further information on the specific number of individual test specimens per build for each parameter is provided, but for tensile strength testing, it's mentioned that OPSCD test specimens from the 23 builds were 3.2 mm thick.
• For minimum thickness determination (TABLE 2): Three sets of 5 specimens each were used for 1 mm, 2 mm, and 4 mm thicknesses (total 15 specimens).
• For through-hole measurements (TABLE 3 & 4): 10 specimens for each through-hole size (5 mm and 2 mm) were measured for both diameter and spacing (total 20 measurements for diameter, 20 for spacing across two categories).
• Data Provenance: The data appears to be from retrospective bench testing conducted internally by Oxford Performance Materials, LLC. There is no information on the country of origin of the data beyond the manufacturer's location in South Windsor, CT, USA.

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

This study involves bench testing for material properties and physical specifications. Therefore, the "ground truth" is established by standardized laboratory testing procedures and predefined acceptance criteria, not by expert human graders. No experts were used in this context to establish a "ground truth" for interpretations as would be in a diagnostic imaging study.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing, there is no human adjudication process involved in reviewing the results; the results are quantitative measurements compared against predetermined numerical acceptance criteria.

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

Not applicable. This is a bench testing study for a medical device's physical and material properties, not a study evaluating human reader performance with or without AI assistance in a clinical setting.

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

Not applicable. This is not an AI algorithm study; it is hardware bench testing.

7. The Type of Ground Truth Used

The ground truth used for this study is based on predefined engineering specifications and material property standards. These specifications are derived from statistical analysis (mean +/- 3 standard deviations for some parameters, or a percentage match for others) established from the initial 23 builds, and industry standards for material characteristics. For the through-hole measurements, the ground truth is the nominal design value with a specified tolerance.

8. The Sample Size for the Training Set

• For establishing final QC specifications (TABLE 1): The "training set" for these specifications could be considered the 23 builds from which the mean and standard deviation values were calculated to define the acceptance criteria.

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

The "ground truth" (i.e., the acceptance criteria and reference values) for the training set (the 23 builds) was established through statistical analysis of the measured outcomes from these 23 builds. For parameters like Tg, Specific Gravity, Tensile Stress, Elongation, and Young's Modulus, the acceptance criteria were defined as "Mean +/- 3SD", "Mean - 3SD", or "Mean + 3SD" based on the data from these 23 builds. For FTIR, it was a "≥95% Match to a Designated PEKK Standard". This indicates an internal reference standard was used.

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