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Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. The elemental composition of Interface Bone Void Filler granules is Si, Ca. Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.

Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Interface Bone Void Filler:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparative equivalency study rather than a study with pre-defined acceptance criteria against specific performance metrics for the subject device alone. The goal was to demonstrate equivalence to a predicate device. Therefore, the "acceptance criteria" here implicitly refers to the demonstration of equivalence.

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

• Sample Size for Physical/Chemical Testing: Not explicitly stated as a numerical sample size. The document mentions "detailed side-by-side material characterization was performed" and lists analytical methods. This implies sufficient samples were tested for each method to ensure accurate characterization.
• Sample Size for Animal Model: Not explicitly stated numerically. The text refers to "a posterolateral spine fusion animal model." More details (e.g., number of animals, number of implants per animal) would typically be in the full study report, but are absent in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin for the animal study, if it was retrospective or prospective). The animal model description suggests it was a prospective animal study conducted to compare the devices.

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

This information is not provided in the given document extract. The summary mentions "radiographic, morphometric and histologic performance" in an animal model, which implies assessment by trained individuals (e.g., veterinary radiologists, pathologists), but their number or qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given document extract. For the animal study's assessment of radiographic, morphometric, and histologic performance, no adjudication method (e.g., 2+1, 3+1) is described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of two medical devices (bone void fillers) against each other, and it does not involve human readers interpreting images with or without AI assistance. This type of study is typically done for diagnostic imaging devices.

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

This question is not applicable as the device is a bone void filler, not an AI algorithm. Therefore, an "algorithm only, without human-in-the-loop performance" study was not performed.

7. The Type of Ground Truth Used

For the animal model study, the "ground truth" was established by radiographic, morphometric, and histologic analyses. This implies:

• Radiographic: Interpretation of X-rays or other imaging by experts.
• Morphometric: Quantitative measurements of bone formation or other relevant structures from images or histological sections.
• Histologic: Examination of tissue samples under a microscope by pathologists to assess bone ingrowth, material resorption, inflammation, etc.

8. The Sample Size for the Training Set

This question is not applicable. The device is a bone void filler, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.

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

This question is not applicable as there is no training set for an AI algorithm.

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Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. The elemental composition of Interface Bone Void Filler granules is Si, Ca, Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.

The provided text describes the Interface Bone Void Filler and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NovaBone Resorbable Bone Graft Substitute) through:

• Material Characterization: Comparing chemical composition, physical properties, and performance characteristics (e.g., dissolution rates).
• Animal Model Study: Comparing radiographic, morphometric, and histologic performance of the subject device to the predicate device in an animal model.

Therefore, I cannot provide the requested table or detailed study information for acceptance criteria related to AI/ML device performance.

However, I can extract information related to the equivalence study as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical medical device (bone void filler) and not an AI/ML device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar metrics for an algorithm's performance is not applicable to the provided text. The "performance" assessment here is about demonstrating equivalence to a predicate device.

The following points (2-9) are not applicable to the provided document as it describes a physical bone void filler, not an AI/ML medical device. Therefore, the information regarding sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

I can only state that:

2. Sample size, data provenance: The document mentions an "animal model" for the performance comparison but does not specify the number of animals used or their origin. It is a prospective study in the sense that the sponsor conducted it to demonstrate equivalence.
3. Number of experts and qualifications: Not applicable. Ground truth was established through scientific analysis (chemical, physical, animal model results).
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI performance with human readers.
6. Standalone (algorithm only) performance: Not applicable. This is for AI performance.
7. Type of ground truth: For the material characterization, it's based on analytical measurements (e.g., SEM/EDXA, ICP/OES, FT-IR, XRD, laser diffraction, calcium-specific electrode). For the animal study, it's based on radiographic, morphometric, and histologic assessments.
8. Sample size for training set: Not applicable (no AI/ML algorithm involved).
9. How ground truth for training set was established: Not applicable (no AI/ML algorithm involved).

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The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed Femoral neck and trochanteric fractures of the proximal femur

Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, 32, 36, 40mm Apex Modular heads.

The provided text describes a 510(k) summary for the Interface Acetabular System, Acetabular Insert. The documentation primarily focuses on the device's design, materials, indications for use, and a comparison to predicate devices, along with non-clinical testing.

Here's an analysis of the requested information:

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: The document does not specify the exact number of samples used for each non-clinical test (ROM analysis, artificial aging, push-out & lever-out). It only states "All samples tested."
• Data Provenance: Not applicable in the context of this device and testing. The tests are in vitro mechanical/material tests, not data derived from human subjects or clinical settings based on a specific country of origin or retrospective/prospective nature.

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

• This information is not applicable as the document explicitly states, "No clinical studies were performed." The "ground truth" for the non-clinical tests would be the performance standards defined in the ASTM and ISO standards, which are engineering specifications, not expert medical consensus.

4. Adjudication method for the test set:

• This information is not applicable as there were no clinical studies involving human readers or subjective interpretations of data that would require an adjudication method. The testing involved objective physical measurements against established engineering standards.

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 was not done. This is a medical device (hip insert), not an AI diagnostic or image analysis tool. The document explicitly states, "No clinical studies were performed."

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

• This information is not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by engineering performance standards specified by ASTM F2003-02 (extreme artificial aging) and ISO-21535-2007 (ROM analysis), along with industry-standard "Push-out & Lever-out Test" criteria.

8. The sample size for the training set:

• This information is not applicable as no clinical studies or AI/machine learning models were involved in the evaluation of this device.

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

• This information is not applicable as no clinical studies or AI/machine learning models were involved.

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The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• e Rheumatoid arthritis:
• . Correction of functional deformity;
• . Congenital dislocation:
• . Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur. .

The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

• Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
• Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This is an orthopedic implant, not an AI-assisted diagnostic tool.

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.): Not applicable in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

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Interface "" is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface "M when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers.

Interface ™ is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface "1", any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.

Interface™ is a ceramic primer which allows the clinician to bond any type of ceramic to a tooth substrate without the pre-application of hydrofluoric acid. Interface™ is prepared by mixing one drop of each component and then waiting 30 seconds for the materials to co-mix. The advantage of being able to mix these chemistries just prior to use, assures the clinician that the mixture is always fresh. Since both chemistries are separate prior to mixing the shelf life of the materials is very stable. In comparison, traditional hydrolyzed silane has an extremely short shelf life which can unknowingly jeopardize bond strengths once near expiration or expired.

Interface™ can be used to prime/ condition tooth structure prior to repairing a tooth to ceramic restoration. The need to acid etch the substrates prior to bonding with either phosphoric or hydrofluoric acids is not necessary. As a result this eliminates any confusion for the clinician on how to prep the restoration for successful bonding.

Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) submission for a dental bonding adhesive named "Interface™," along with the FDA's response letter.

The submission primarily describes:

• The device name, common name, classification, and product code.
• Identification of a legally marketed predicate device (hydrolyzed silane).
• A description of the "Interface™" device, highlighting its advantages over the predicate device, particularly its ability to bond to ceramic, dentin, and enamel without the need for hydrofluoric or phosphoric acid etching.
• The FDA's letter of substantial equivalence, allowing the device to be marketed.
• Indications for Use for the "Interface™" device.

There is no mention of:

• Acceptance criteria (e.g., target performance metrics like sensitivity, specificity, accuracy, bond strength thresholds).
• Any studies conducted to demonstrate the device meets specific performance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• MRMC studies or human-in-the-loop performance.
• Information about training sets or how ground truth was established for development.

Therefore, I cannot provide the requested table and information based on the given text.

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The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.

The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.

The provided text describes the Stöckert Instrumente Interface Module IDDD, an accessory to cardiopulmonary bypass heart-lung machines. The document focuses on its substantial equivalence to predicate devices and testing performed to ensure its safety and functionality.

Here's an analysis of the acceptance criteria and study information contained in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" in the conventional sense for a test set of data. Instead, the testing involved:

• Physical Devices: Stöckert S3 System, SC heart-lung system, and an Interface Module IDDD installed in each.
• Operating Conditions: No-load and full-load states for EMI/EMC testing, with pump heads running at 100 RPM.

The data provenance is not specified, but given the manufacturer (Stöckert Instrumente GmbH, Munich, Germany) and the testing descriptions, it can be inferred that the testing was conducted prospectively by the manufacturer. No information regarding country of origin of "data" is provided, as the "data" being evaluated is the device's operational performance, not clinical or diagnostic data.

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

This information is not provided in the document. The testing described is primarily engineering and safety testing, not diagnostic performance evaluation requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where disagreement among experts needs resolution to establish ground truth for classification or diagnostic tasks. The described tests are objective pass/fail criteria based on device functionality and safety standards.

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 was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Interface Module IDDD is an accessory for data output and documentation, not an interpretive or diagnostic AI tool.

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

Yes, in essence, standalone testing was performed. The described electrical safety, functional safety, and EMI/EMC tests evaluate the device's performance independently of human interaction beyond setting up and operating the system for the test. The "algorithm" here refers to the device's internal logic for data transfer and processing. The tests establish that the device operates correctly on its own and does not interfere with the primary heart-lung machine functions.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is primarily engineering specifications, safety standards (IEC 60601-1), and functional requirements. For example:

• Electrical Safety: Compliance with IEC 60601-1.
• Functional Safety: Correct operation of safety-critical pump functions.
• EMI/EMC: No pump stops, no pump runaway, no sensor alarms, stable displayed values, and correctly functioning IDDD.
• CAN Message Acceptance: Only specified messages are accepted by respective modules.

These are objective, measurable outcomes directly related to the device's design and intended function, rather than subjective interpretations like pathology results or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Interface Module IDDD is a hardware accessory for data transfer, not an AI or machine learning model that requires a "training set" of data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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