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Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surqically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling, and cellmediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 1 cc, 2.5 cc, 5 cc, and 10 cc syringe volumes.

OssDsign Catalyst is identical to the currently marketed product Osteo3 ZP Putty (K193075). The cleared Osteo3 ZP Putty was launched in the USA in October 2021 and marketed under the name OssDsign Catalyst.

Here's a breakdown of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary for the Catalyst Bone Void Filler.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed clinical study demonstrating the device's standalone performance against specific acceptance criteria. The performance testing summarized supports the claim of substantial equivalence. Therefore, the "acceptance criteria" here are inferred from the types of non-clinical testing performed and the comparison to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily relies on non-clinical testing and refers to data from the prior clearance (K193075) of an identical device.

• Sample Size: Specific sample sizes for each non-clinical test (e.g., sterilization, biocompatibility, mechanical testing) are not detailed in this summary. It states "non-clinical testing data were submitted" for K193075.
• Data Provenance: The data provenance is from non-clinical (laboratory and animal) studies conducted in support of the original device clearance (K193075). The specific countries where these tests were performed are not mentioned. The studies were retrospective in the context of this 510(k) submission, as they were conducted for a prior clearance.

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

This information is not provided in the 510(k) summary. Given that it's primarily non-clinical testing and comparison to predicates, the concept of "experts establishing ground truth for a test set" in the context of clinical reads (like a radiologist for imaging devices) doesn't directly apply in the same way. The "ground truth" for non-clinical tests is established by the methods, standards, and results of those tests.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" typically apply to human interpretation of data (e.g., medical images) where discrepancies need resolution. The testing described here is primarily non-clinical compliance and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as described in this 510(k) summary. This type of study would compare human performance with and without AI assistance, which is not relevant for a bone void filler device in this context. The document focuses on demonstrating substantial equivalence through non-clinical data and comparison of device characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the Catalyst Bone Void Filler. This device is a bone void filler, not an algorithm or AI-powered diagnostic/therapeutic tool. Therefore, "standalone algorithm performance" is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's characteristics and equivalence was established through:

• Non-clinical test results: Chemical composition analysis, physical properties testing, sterility testing, pyrogenicity, bacterial endotoxin, shelf life, biocompatibility studies.
• Animal testing: Specifically, mechanical performance in a posterolateral spine fusion animal model for the reference device (K193075).
• Comparison to predicate devices: The "ground truth" for substantial equivalence heavily relies on demonstrating that the Catalyst Bone Void Filler's characteristics and performance are comparable to (or identical to, in the case of K193075) legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical implant, not an AI algorithm that requires a "training set."

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

This information is not applicable/not provided for the same reason as #8.

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OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

The provided text is a 510(k) summary for a medical device called OSSDSIGN Cranial PSI. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not include the detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be necessary to fully answer your request.

The document states that "Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device," and mentions "in vivo studies show biocompatibility, adequate resorption rate and osteoconduction." but doesn't provide the acceptance criteria for these.

Based on the provided text, I can only provide the following information:

1. A table of acceptance criteria and the reported device performance:

Note: The document implies these as critical performance aspects, but does not explicitly state quantitative acceptance criteria or detailed performance metrics.

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

• Sample Size for Test Set: 52-week sheep implantation study. The exact number of sheep is not specified.
• Data Provenance: In vivo (animal study - sheep). The country of origin is not specified.

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

This information is not provided in the document. The study mentioned is an in vivo implantation study, which typically relies on pathological analysis rather than expert human interpretation of imaging.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This information is not provided in the document. The device, OSSDSIGN Cranial PSI, is a patient-specific implant for cranial reconstruction, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.

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

This information is not provided in the document. As mentioned, the device is an implant, not an algorithm.

7. The type of ground truth used:

For the in vivo implantation study, the ground truth would typically be established through histopathological analysis of tissue samples from the implanted area to assess biocompatibility, resorption, and osteoconduction.

8. The sample size for the training set:

This information is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a training set.

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

This information is not provided in the document, as it's not relevant to this type of device.

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Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.

The provided text describes a 510(k) premarket notification for "OSSDSIGN Cranial PSI Accessories." This document focuses on demonstrating substantial equivalence to a predicate device and includes details on biocompatibility and performance testing of the accessories. However, it does NOT describe an AI/ML medical device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document primarily focuses on physical, non-AI medical device accessories. Therefore, I cannot extract the requested information in the format of an AI/ML device study.

Here's why the prompt cannot be fulfilled from the provided text:

• No mention of AI/ML: The document does not refer to any artificial intelligence, machine learning, algorithms, or software intended for automated analysis or diagnosis.
• Device type: The described devices are physical accessories (Anatomical Model, Plastic Drawing Guide, Cranial Implant Trial) made from PA2200 polyamide, designed to aid in the implantation of a cranioplasty plate.
• Testing methods: The performance tests detailed are related to physical properties like deformation, particle generation, and dimensional integrity, not algorithmic accuracy or clinical outcome prediction by an AI model.
• Ground Truth/Experts: The concepts of "ground truth," "expert consensus," "human readers," "training set," or "test set" in the context of data used for AI model development or validation are absent.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

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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 Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with or with or with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

The provided document is a 510(k) summary for the OSSDSIGN Cranial PSI device. It includes information about acceptance criteria and mechanical/biocompatibility testing comparing it to a predicate device, but it does not describe studies involving human performance or assessment by experts. Therefore, many of the requested fields cannot be answered from this document.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

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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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