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OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSDSIGN Cranioplug.

Upon reviewing the provided FDA 510(k) summary, it's important to note that this document describes a medical device (a burr hole cover) and its non-clinical testing, not a diagnostic AI/ML device. Therefore, many of the requested categories, such as data provenance, expert adjudication, MRMC studies, standalone performance with ground truth for AI, etc., are not applicable as this is not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the "OSSDSIGN Cranioplug" (subject device) to a legally marketed predicate device ("OSSDSIGN Cranioplug") through bench and biological performance testing.

Acceptance Criteria and Device Performance for OSSDSIGN Cranioplug

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied based on establishing substantial equivalence to the predicate device. The goal is to demonstrate that the new device performs as safely and effectively as the predicate.

Regarding AI/ML Specific Questions (Not Applicable to this Device):

The following questions are not applicable to the OSSDSIGN Cranioplug as it is a physical medical implant (burr hole cover), not an AI/ML diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: Not applicable. This involves physical device testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device involves expert annotations; for this physical device, "ground truth" is established by physical measurements and biological assays.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" is derived from standardized physical testing methods (e.g., universal testing machine, dynamic load simulation) and biological assays (cytotoxicity, in vivo implantation results/histology).
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Non-Clinical for a Physical Device):

The study described is a non-clinical evaluation to demonstrate the substantial equivalence of the OSSDSIGN Cranioplug (subject device) to its predicate device (an earlier version of the Cranioplug, K140309).

Key aspects of the study:

• Objective: To show that the subject device is as safe and effective as the predicate device, despite minor differences in materials (Titanium grade) and dimensions (titanium thickness, additional size).
• Methodology: Bench testing and biological performance testing.
  • Bench Testing:
    • Energy absorption, flap reattachment: Devices installed in an anatomical model and tested in a Universal Testing Machine to a 2mm displacement to determine deformation energy.
    • Flap Fixation Dynamic Load: Three Cranioplugs fixating a flap in an anatomical model, tested with an 8.5 kg head weight simulating 50 years of sleep with hourly repositioning.
  • Biological Performance:
    • Cytotoxicity: ISO elution method (ISO 10993-5) using extracts in IX MEM at 37°C for 24 hours.
    • In vivo implantation: A 52-week sheep implantation study, compliant with ISO 10993-6.
• Results: The subject device met the performance standards demonstrated by the predicate device in all tests.
  • Energy absorption was identical to the predicate (0.06 J).
  • No flap deformation observed under dynamic loading.
  • No evidence of cytotoxicity.
  • Biocompatibility, adequate resorption rate, and osteoconduction were observed in vivo.
• Conclusion: Nonclinical tests demonstrate that OSSDSIGN Cranioplug003 is as safe and effective as its legally marketed predicate device.

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OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.

The document does not describe acceptance criteria for an AI/ML powered device, but rather for a Burr Hole Cover (OssDsign Cranioplug). The sections of the document describing testing (pages 4 and 5) outline bench performance characteristics and material composition tests for the OssDsign Cranioplug and its predicates.

Therefore, many of the requested fields are not applicable (N/A) as they relate to software performance evaluation, not a physical medical device.

Here's an interpretation based on the provided document for the OssDsign Cranioplug:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample sizes for each test. For the physical properties (compressive strength, falling load, 12-hour load), small sample sizes of devices are typical. For the biological tests (dissolution, cytotoxicity, sensitivity), multiple samples would be tested to ensure consistency.

• Data Provenance: Not explicitly stated, but these are laboratory bench and animal (rabbit) tests conducted for a medical device. It is generally understood to be prospective data generated specifically for the 510(k) submission.

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

N/A - The "ground truth" for these tests is based on objective measurements and established scientific standards (e.g., ISO standards, material properties, biological responses) rather than expert consensus on interpretive tasks. The "experts" would be the scientists and engineers conducting and analyzing these tests.

4. Adjudication Method for the Test Set

N/A - Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical images or diagnoses, not for objective physical or biological bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A - This type of study is for evaluating the performance of diagnostic or screening devices, often involving human readers interpreting outputs (e.g., images). The OssDsign Cranioplug is a physical implantable device, not an interpretive one.

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

N/A - This concept applies to AI/ML algorithms. The OssDsign Cranioplug is a physical medical device.

7. The Type of Ground Truth Used

• Bench Performance Tests (Compressive Strength, Falling Load, 12 Hour Load): Objective physical measurements against established engineering principles and comparison to predicate device performance.
• Biological Tests (Dissolution, Cytotoxicity, Sensitivity): Objective biological responses measured against established ISO standards and comparison to control articles.

8. The Sample Size for the Training Set

N/A - "Training set" refers to data used to train AI/ML algorithms. The OssDsign Cranioplug is a physical device and does not involve AI/ML.

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

N/A - As above, this is not applicable to a physical medical device.

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