Search Results

Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.2 diameter screw is for fixing non-resorbable membrane or non-resorbable titanium membrane (Osstem OssBuilder OB2 and OB3), cleared in K172354.

The specifications of the proposed device are as follow;

• Bone Screw
• Diameter (mm): Ø1.2
• Length (mm): 3.0, 4.0, 5.0

This document is a 510(k) clearance letter for a bone screw, not a study evaluating an AI/software as a medical device (SaMD). Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/SaMD.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new Bone Screw device to existing predicate devices based on:

• Indications for Use: The new device has the same intended use as the predicate.
• Technological Characteristics: Similarities in material (Titanium Alloy), manufacturing process (machined), design, and sterilization method (Gamma Irradiation).
• Performance Testing: Non-clinical tests (Driving Torque, Axial Pullout Strength, Torsional Strength) were conducted to show the new device performs comparably to the predicate, especially regarding a new smaller thread diameter.
• Biocompatibility and Shelf-life: Leveraged data from the predicate device due to material and packaging similarities.
• MR Compatibility: Assessed using scientific rationale and published literature, not a study with acceptance criteria.

Therefore, I cannot extract the requested information as it pertains to an AI/SaMD from this document.

If you have a document describing the performance study of an AI/SaMD, I would be happy to help you extract that information.

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The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.

The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.

The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.

This document is a 510(k) summary for a Bone Marrow Biopsy Needle. It includes a comparison to a predicate device and non-clinical testing. However, it does not include acceptance criteria for device performance, nor does it describe a study proving the device meets specified criteria. The document explicitly states "No clinical data was provided."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information provided only demonstrates that bench tests (puncture test, torque test, stiffness test, toughness test, and corrosion resistance test) were conducted and "all test results meet the performance requirements." Furthermore, an "ex vivo sample quality comparison" was performed, and "all the result shows the subject are substantially equivalent to the predicate devices." No specific criteria or detailed results for these tests are presented.

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Bone Suppression Software is an image processing technology to improve the visibility of soft tissues in the lung area by suppressing the signals of ribs and clavicles in chest x-ray images.

The purpose of this software is to provide Bone Suppression images. The software receives the exposed frontal plain chest X-ray images as inputs, then starts processing each image from the Senciafinder Gateway application. After the software is started, it performs the extraction process of the lung field area and Bone Suppression process to attenuate the signals of bones, and outputs Bone Suppression images with attenuated signals of ribs and clavicles in the extracted lung field area.

In conjunction with the Senciafinder Gateway, images are received from diagnostic imaging equipment via network. Received images are applied Bone Suppression processing and output to image display system such as PACS / workstation via network.

The provided text describes a 510(k) premarket notification for "Bone Suppression Software" (K240281) by Konica Minolta, Inc. The core information regarding acceptance criteria and performance studies is present in Section VII, "PERFORMANCE DATA."

However, the provided text explicitly states: "No clinical studies were required to support the substantial equivalence." This means that the 510(k) submission relied on non-clinical performance data and comparison to a predicate device, rather than new clinical trials with human subjects.

Therefore, many of the requested points in your prompt, such as data provenance for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance on a clinical test set, and detailed training set information, are not applicable or available from the provided text, because a clinical study (as typically understood in terms of human subjects and diagnostic performance analysis) was not performed or deemed necessary for this 510(k) clearance based on the provided document. The performance data relied on software verification and validation activities.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

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

• Acceptance Criteria: The text states, "All the verification and validation activities required by the specification and the risk analysis for the Bone Suppression Software were performed and the results showed that the predetermined acceptance criteria were met." However, the specific acceptance criteria (e.g., in terms of image quality metrics, bone suppression ratios, or processing speed) are not detailed in the provided document.
• Reported Device Performance: Similarly, the specific quantitative performance metrics are not reported in the document. It only states that the device "performs as specified and functions as intended."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable for a clinical test set (as no clinical study was required for substantial equivalence). The performance data referred to "Software Verification and Validation Testing," which typically involves simulated data, historical non-clinical data, or controlled laboratory tests, not a clinical "test set" in the diagnostic performance sense. The text does not provide details on the nature or origin of the data used for V&V activities.

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

• Not applicable. As no clinical study was performed or required for the 510(k) substantial equivalence, no expert-established ground truth for a clinical test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. See point 3.

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. The document explicitly states, "No clinical studies were required to support the substantial equivalence." Therefore, no MRMC study evaluating human reader improvement with AI assistance was conducted or reported for this 510(k).

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

• The document implies that standalone performance was assessed as part of "Software Verification and Validation Testing" to ensure it "performs as specified and functions as intended." However, the metrics of this standalone performance (e.g., objective image quality measurements, quantitative bone suppression metrics) are not provided in the text. It's a statement that V&V was successful, not a report of the results themselves.

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

• Not explicitly stated for the V&V activities. For "Software Verification and Validation Testing," ground truth would typically be established based on the specifications and expected outputs of the software (e.g., if a bone is known to be in a certain location, can the software correctly identify and suppress it?). This is different from clinical ground truth based on expert reads, pathology, or outcomes. The document does not elaborate on how this "ground truth" for V&V was established.

8. The sample size for the training set

• Not applicable/Not provided. The document does not mention details about the development (training) of the software. As it's a 510(k) submission, the focus is on verification and validation against a predicate, not detailing the original development process.

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

• Not applicable/Not provided. See point 8.

Summary based on the provided text:

The acceptance criteria for the Bone Suppression Software were met through "Software Verification and Validation Activities." These activities confirmed that the device "performs as specified and functions as intended." However, the specific quantitative acceptance criteria and the detailed performance results are not disclosed in this 510(k) summary. Crucially, no clinical studies involving human subjects were required or conducted to support this substantial equivalence determination, meaning aspects like test set data, expert ground truth, adjudication, and MRMC studies are not part of this submission's evidence as described.

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The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

The Bone Anchor is a single-use device for temporary short-term fixation of surgical tools or accessories during a single surgical procedure. The Bone Anchor may be used during image-guided or MR interventional procedures. This device is not intended to create a seal or barrier from potential infection and has not been tested for long-term (>24 hours) use. The Bone Anchor components are listed below along with their function:

• Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull.
• Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull.
• Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place.
• Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory.
• . Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.

The provided text is a 510(k) summary for the ClearPoint Neuro Bone Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not available in this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing for the Bone Anchor and mentions testing for the predicate and reference devices. However, it does not explicitly
state specific acceptance criteria or provide quantitative performance results (e.g., exact load values, push force values, or targeting error measurements) for the Bone Anchor, only noting that "meets all test specifications" for demonstrating substantial equivalence.

Note: The document states that the subject device "meets all test specifications" and performs "as well as the predicate device" but does not provide the numerical values for these specifications or the device's performance against them. Similarly, for the predicate Microtable, it lists "Dimensional Stability" and "Load Testing" but no specifics. For the reference device, it lists the same tests as the subject device.

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

The document does not specify the sample size used for the described performance testing. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.

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

Not applicable. The document describes engineering and mechanical performance testing, not a study involving human experts establishing ground truth for clinical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment of data.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

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

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing mentioned (Load, Push Force, Insertion Force, Retention Force, Removal Force, Driver Pull Force Testing), the "ground truth" would be established by the engineering and mechanical testing standards and methodologies used to evaluate the device's physical properties and functionality. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument and does not involve AI/ML requiring a training set.

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

Not applicable. As noted above, there is no training set for this type of device.

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· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

· Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading

Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

This appears to be a 510(k) summary for a dental implant, "Bone Chamber Implant," seeking substantial equivalence to existing predicate devices. Consequently, the document describes non-clinical bench testing to demonstrate equivalence, rather than clinical trials with human subjects. Therefore, many of the requested items related to clinical study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) will not be applicable and the acceptance criteria will be based on engineering performance standards.

Here's an analysis based on the provided text:

Key Takeaway: The device's acceptance criteria and proven performance are primarily based on demonstrating mechanical equivalence to predicate devices through bench testing, specifically fatigue testing, following ISO and FDA guidance. No clinical studies were performed.

Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are the ability of the device to meet the specified performance standards in the referenced guidance documents and ISO standards, and to perform comparably to the predicate devices. The "reported device performance" is that the device met these criteria.

Study Details (Non-Clinical Bench Testing)

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

   • Sample Size: Not explicitly stated as a numerical count for each test (e.g., number of implants tested for fatigue). The document states "the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'." For regulatory submissions like 510(k), compliance with the standards' requirements for sample size is assumed.
   • Data Provenance: The studies were non-clinical bench tests, not involving human data. The company is MegaGen Implant Co., Ltd., located in Daegu, South Korea. The testing was conducted internally or by a contracted lab to meet international and FDA standards.

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

   • Not Applicable. This was non-clinical bench testing of physical properties, not an assessment requiring expert clinical judgment or ground truth determination (like image interpretation). The "ground truth" here is the physical measurement against a standard.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. This refers to clinical adjudication, which is not relevant for bench testing.

4. 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. No MRMC study was done, as this is a physical dental implant, not an AI software or imaging device that human readers would interpret.

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

   • Not Applicable. This is a physical device, not an algorithm.

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

   • Engineering Standards and Specifications. The "ground truth" for non-clinical testing refers to the established requirements and thresholds defined by international standards (e.g., ISO 14801) and FDA guidance documents for medical device performance (e.g., fatigue strength, biocompatibility, sterilization efficacy). The device's performance is compared against these quantitative and qualitative criteria.

7. The sample size for the training set:

   • Not Applicable. This refers to the training of an algorithm or AI model. This device is a physical product.

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

   • Not Applicable. As above, this refers to algorithm training.

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The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.

The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.

The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.

The provided text describes the 510(k) premarket notification for the "Bone Bolt System." It outlines the device's indications for use, description, predicate devices, materials, and performance data. However, the document does not contain information about a study proving the device meets acceptance criteria related to an AI/machine learning model.

The performance data section explicitly states: "No clinical or animal testing was conducted." The performance characterization was based on in vitro mechanical testing (Torsional Strength Testing, Driving Torque Testing, Axial Pull-out Strength Testing, Static and Dynamic Bending Testing) according to ASTM standards.

Therefore, I cannot fulfill the request to provide the detailed information about an AI/ML study, including:

1. A table of acceptance criteria and reported device performance (for an AI/ML model)
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and qualifications
4. Adjudication method for the test set
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
6. Standalone (algorithm-only) performance
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How ground truth for the training set was established

The document describes a traditional medical device (metallic bone fixation fastener) and its clearance based on substantial equivalence to predicate devices, supported by in vitro physical performance data. The questions posed are highly relevant to the evaluation of AI/ML-based medical devices, but this document does not pertain to such a device.

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Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement Genta are available in a low and high viscosity version.

The Bone Cement are PMMA, radiopaque bone cements designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement are available in a low and high viscosity version.

The provided text is a 510(k) summary for polymethylmethacrylate (PMMA) bone cements. It details the device's characteristics, intended use, and comparison to predicate devices. However, this document does not contain the specific acceptance criteria or the study results in the format or level of detail requested for the device performance.

The section titled "PERFORMANCE DATA" (starting on page 9) lists the types of performance testing conducted but does not provide quantitative acceptance criteria or the reported device performance. It only states that the performance data demonstrate that the new devices are substantially equivalent to the predicate devices, and meet the requirements of the Special Controls Guidance Document.

Therefore, I cannot complete the table of acceptance criteria and reported device performance from the provided document. Similarly, details about sample sizes, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set specifics for an AI/algorithm are not present as this document pertains to a bone cement, not an AI or imaging device.

If this were an AI/imaging device submission, the provided information would be insufficient to answer most of the requested points.

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Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.

The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.

The provided text is a 510(k) summary for a medical device called "Bone Cement - Normal Viscosity." It describes its indications for use, device description, equivalence to a marketed predicate device, and performance data. However, the document does not describe a study involving an AI/Machine Learning device or a study involving human-in-the-loop performance, expert ground truth adjudication, or statistical performance metrics like sensitivity/specificity or ROC curves typically associated with AI device performance and acceptance criteria.

Instead, this document pertains to a traditional medical device (bone cement) and focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical properties, as well as sterilization, shelf-life, and biocompatibility testing according to established FDA guidance for PMMA bone cement.

Therefore, I cannot fulfill the request to describe acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the type of study outlined in the request (which heavily implies clinical or reader studies for AI performance) was not part of this 510(k) submission.

Summary of why the request cannot be fully answered based on the provided text:

• Device Type: The device is bone cement, not an AI/ML diagnostic or assistive device.
• Study Type: The studies performed are non-clinical, testing physical, chemical, and mechanical properties, sterilization, shelf-life, and biocompatibility. They are not AI performance studies.
• Lack of AI-related metrics: There are no mentions of sensitivity, specificity, AUC, human reader improvement with AI assistance, or any other metrics relevant to AI device performance.
• No Human-in-the-loop or standalone AI performance: The concepts of human readers, expert adjudication, or AI algorithms acting in standalone mode are not applicable to the studies described for bone cement.
• No Training/Test Set Data for AI: There is no mention of training sets, test sets, or ground truth for an AI model because no AI model is being evaluated.

Therefore, for the sake of completeness, I can only state what is described regarding performance criteria for this specific device, which differs significantly from the AI/ML framework requested.

What is described for "Bone Cement - Normal Viscosity" performance testing (non-AI related):

The performance data to establish substantial equivalence were conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Acceptance Criteria and Reported Device Performance (as gathered from the "PERFORMANCE DATA" section):

Regarding the AI/ML specific questions:

1. Sample size for test set and data provenance: Not applicable. This is not an AI/ML device study.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for AI is not established.
3. Adjudication method: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone performance (algorithm only): Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the adherence to material and manufacturing standards for bone cement, not diagnostic accuracy.
7. Sample size for the training set: Not applicable. No AI model is being trained.
8. How the ground truth for the training set was established: Not applicable.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• . non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
• inflammatory degenerative joint disease such as rheumatoid arthritis; ●
• . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• . cuff tear arthropathy (CTA Heads only);
• . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.

The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg made of Trabecular Titanium, intended for uncemented use with the addition of bone screws for fixation to the bone. This glenoid component is part of the SMR TT Augmented Glenoid System (K191746/K200171) that is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration.

This document is a 510(k) premarket notification decision letter from the FDA regarding Bone Screws dia. 5,0 mm manufactured by LimaCorporate S.p.A. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not contain details about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these elements are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools. This document pertains to the substantial equivalence determination of a bone screw, which is a mechanical implant, and its evaluation relies on mechanical testing and comparison to predicate devices, not data-driven performance metrics for an algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as this information is not present. The document explicitly states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device." This confirms that there was no clinical study with a test set of patient data, human readers, or ground truth as you described.
• The testing performed was "Mechanical testing" which demonstrated the device's ability to perform substantially equivalent to the predicate device in:
  • Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
  • Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)

In summary, the provided document is for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, test sets, training sets, expert consensus, MRMC studies, and ground truth are not applicable to the content of this FDA 510(k) premarket notification.

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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone. Bone Tack is a stabilizer that can stably fix the membrane in GBR.

The provided document is an FDA 510(k) Premarket Notification summary for a Bone Screw and Bone Tack device. It generally discusses the device's substantial equivalence to predicate devices based on non-clinical testing. However, it explicitly states that no clinical studies were submitted and therefore does not contain information about acceptance criteria or a study proving the device meets them through clinical performance.

Therefore, I cannot provide details for most of your requested points, as they pertain to clinical or comparative effectiveness studies that were not performed or reported in this document.

Here's what can be extracted based on the information provided, and what cannot:

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

• Cannot be provided. The document does not specify acceptance criteria for clinical performance or any reported device performance that would meet such criteria. It focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No clinical test set was used or reported in this submission. The non-clinical testing details do not specify sample sizes in a way that aligns with "test set" for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No clinical test set or adjudication method is mentioned.

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

• Cannot be provided. No MRMC study was done, and the device is a medical implant, not an AI diagnostic tool.

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

• Cannot be provided. The device is a medical implant, not an algorithm.

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

• Cannot be provided. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Cannot be provided. No training set for an algorithm was used.

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

• Cannot be provided. No training set or ground truth for it was established.

Summary of what the document does provide regarding testing:

The manufacturer performed non-clinical testing to support the substantial equivalence claim. These include:

• Biocompatibility evaluation: Considered following FDA Guidance Document Use of International Standard ISO 10993-1 and ISO 10993 suite of standards. This leveraged information from reference device K172354.
• Sterilization Validation and Shelf-life: Considered following ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
• Mechanical Properties: Evaluated following ASTM F543 with a "worst-case scenario."

The document explicitly states: "No clinical studies are submitted." (Page 7, Section 8)

Therefore, based solely on the provided text, no information is available about clinical acceptance criteria or studies proving device performance against such criteria. The submission relies on substantial equivalence to predicate devices and non-clinical testing.

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