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ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.

ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.

This 510(k) submission aims at introducing new device components, the ArTT Augments and Buttresses and Bone Screws (Revision Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 4mm), Bone Screws (Dia. 4mm)) to be used in combination with the EMPOWR Acetabular Cup System (K190057) manufactured by Encore Medical, L.P.

ArTT Augments and Buttresses are manufactured from Ti6Al4V 3D printed (ISO 5832-3) and are indicated for cementless use to the bone interface; they are affixed to the mating acetabular cup using bone cement. ArTT Augments are available in 9 diameters (Dia. 50mm to 66mm) and 3 eccentricities (Ecc. 10mm, Ecc. 15mm, Ecc. 20mm), while ArTT Buttresses are available in 3 diameters (Dia.50mm, Dia.56mm, Dia.62mm), 3 heights (H. 15mm, H. 30mm, H. 60mm) and 3 configurations (Neutral, Left, Right).

Bone Screws are manufactured from Ti6Al4V (ISO 5832-3 - ASTM F1472); they are intended for cancellous or cortical bone and are available in several lengths.

This FDA 510(k) clearance letter pertains to
"ArTT Augments and Buttresses and Bone Screws" for orthopedic use. It's important to note that this document is a clearance letter, not a detailed scientific study publication. As such, it provides summary information about the device and the types of testing performed to demonstrate substantial equivalence, rather than a deep dive into specific study methodologies or acceptance criteria with detailed performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific pull-out force thresholds) or precise numerical performance results for the ArTT Augments and Buttresses and Bone Screws.

Instead, it states:

• "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device."
• "Other performance requirements were fulfilled through rationales and comparisons with previously cleared components (K210717, latest 510(k) approval)."

This implies that the acceptance criteria were based on:

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

• Sample Size for Test Set: The document states that mechanical testing was performed on "worst case components or constructs." However, it does not specify the exact number of samples or specimens used for each test (e.g., how many augments, how many screws of each type).
• Data Provenance: The studies were "Non-clinical testing" conducted by the manufacturer, Limacorporate S.p.A. The location of the testing laboratories or specific origin of data (e.g., retrospective/prospective in a clinical sense) is not described, as these are non-clinical (mechanical) tests.

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

This section is not applicable as the studies described are non-clinical (mechanical) tests. The "ground truth" for mechanical testing is typically established by engineering standards (e.g., ASTM F543) and internal protocols, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set:

This section is not applicable for non-clinical mechanical testing, where adjudication methods like 2+1 or 3+1 by human experts are not used. Performance is measured against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The clearance is for a physical orthopedic implant system, not an AI software/diagnostic device that would involve human readers interpreting cases.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not an algorithm or AI.

7. The Type of Ground Truth Used:

For the mechanical tests conducted, the "ground truth" implicitly refers to:

• Engineering Standards: Specifically mentioned is ASTM F543 for torsional properties, driving torque, and pull-out load of bone screws.
• Internal Protocols: Used for fretting fatigue testing.
• Performance of Predicate Devices: The measured performance of the ArTT Augments and Buttresses was deemed "substantially equivalent" to that of the predicate devices. This means the performance of the predicate likely served as a benchmark or reference point for establishing acceptable performance.

8. The Sample Size for the Training Set:

This section is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as above (physical medical device, no training set).

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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 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 aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.

The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.

This document describes the aap Cannulated Headless Bone Screws, a medical device for bone fixation. Since this is a 510(k) summary, the core of the submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing brand-new performance criteria for a novel device. Therefore, the "acceptance criteria" here are largely defined by demonstrating that the new device performs at least as well as and shares similar characteristics with the predicate devices.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit acceptance criteria with numerical targets as one might see for a novel device, the "acceptance criteria" here are met by demonstrating similarity and comparable performance to the predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices or clinical cases for this submission's testing. The non-clinical performance data mentions "mechanical testing of the subject device screws according to ASTM F543." ASTM F543 outlines test methods, but the specific number of screws tested is not provided in this summary.
• Data Provenance: The data is primarily non-clinical performance data which includes mechanical testing, sterilization validation, and references to previous submissions (K111316, K130590, K131459, K161616) for biocompatibility, packaging, and shelf-life. There is no clinical data included in this submission. The origin of the reference data for predicate devices is not specified, but previous 510(k) submissions would have their own established provenance.

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

Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not on establishing ground truth via expert review of clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There's no test set requiring human adjudication for diagnostic or interpretive tasks. The evaluation is based on engineering specifications, material standards, and mechanical test results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (bone screws and K-wires), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering Specifications and Material Standards: Compliance with recognized standards like ASTM F136, ISO 5832-3, ASTM F138, ISO 5832-1, ASTM F543, ISO 17665-1, ISO 10993-1. These standards define the acceptable properties and performance for such devices.
• Bench Testing: Mechanical testing data according to ASTM F543.
• Referencing Predicate Devices: The established regulatory clearances and performance data of the cited predicate devices (K111316, K130590, K131459, K161616) serve as a de-facto "ground truth" for comparison under the substantial equivalence pathway.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable, as there is no training set.

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The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures.

The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following:

• 5x - ClearPoint Bone Screw Fiducials
• 1x Bone Screw Fiducial holder
• 1x Screwdriver

The Bone Screw Fiducial is made of titanium and comprised of a threaded portion that is screwed into a patient's skull and a non-threaded, exposed length that protrudes from the patient's head. The head contains a feature for compatibility with a T8 Torx screwdriver and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool.

The Bone Screw Holder is intended to assist in holding the Bone Screw Fiducials securely to the screwdriver during anchoring. This is accomplished by allowing the screwdriver to mate with the Bone Screw Fiducial without the Bone Screw Fiducial separating from the assembly therefore allowing it to be anchored to the skull.

The provided document is a 510(k) premarket notification for the ClearPoint Bone Screw Fiducials. It does not contain information related to software or AI/ML. The document describes a medical device, specifically bone screw fiducials, and compares them to a predicate device. The testing described is "bench testing" focusing on physical, performance, and safety requirements, and simulated workflow testing.

Therefore, for aspects related to AI/ML or a multi-reader multi-case (MRMC) study, the answer will be that this document does not contain that information.

Here's an analysis based only on the provided text, addressing the points where information is available:

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

The document states: "The results from all testing demonstrated that the ClearPoint Bone Screw Fiducials comply with all design and performance specifications."
It also mentions: "ClearPoint Bone Screw Fiducials have been demonstrated to meet all test specifications and has been shown to be as safe, as effective, and to perform as well as the predicate device."

However, the specific "acceptance criteria" and "reported device performance" metrics (e.g., specific thresholds for physical properties, accuracy in imaging, etc.) are not detailed within this document. The document summarizes that the device met these criteria but does not provide them in a table format.

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

The document describes "bench testing" and "simulated workflow testing." It does not specify sample sizes for these tests or discuss data provenance (country of origin, retrospective/prospective) in the context of clinical data or patient-derived data, as the device is physical hardware.

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)

This N/A. Ground truth, in the context of AI/ML, refers to expert-labeled data. The testing described is bench testing of a physical device. There is no mention of experts establishing a "ground truth" for imagery or diagnostic performance here.

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

This N/A. No adjudication method is described, as the testing is for physical device performance, not interpretation of data by multiple readers.

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 MRMC comparative effectiveness study was conducted or mentioned in this document. This document is for a physical medical device (bone screw fiducials), not a software or AI/ML product.

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

No standalone algorithm performance study was done or mentioned. This document is for a physical medical device.

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

This N/A. For a physical device, "ground truth" typically refers to engineering specifications met through measurements and physical verification. The document states "Design Verification testing was performed relative to these specifications." These specifications serve as the "ground truth" for the device's physical and performance characteristics. There is no biological or diagnostic ground truth described in this submission.

8. The sample size for the training set

This N/A. There is no training set mentioned, as this is not an AI/ML device.

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

This N/A. There is no training set mentioned, as this is not an AI/ML device.

Summary regarding AI/ML aspects:

The provided document describes a 510(k) premarket notification for a physical medical device (ClearPoint Bone Screw Fiducials). It relies on bench testing to demonstrate performance and substantial equivalence to a predicate device. The information requested regarding AI/ML-specific testing, such as MRMC studies, training/test set sizes, data provenance, expert ground truth establishment, and algorithm-only performance, is not relevant to this submission and therefore not present in the provided text.

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Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Metal Bone Screw are used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Metal Bone Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw can be used alone or in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Bone Screw are made of Ti-6A1-4V ELI following ASTM F136. Metal Bone Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document is a 510(k) premarket notification for a medical device called "Metal Bone Screw." It is a regulatory filing with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating AI or software performance. Therefore, most of the requested information regarding acceptance criteria, AI study design, human-in-the-loop performance, and training/test set details is not applicable to this document.

However, I can extract the relevant information from this document:

Device Description and Purpose:

The "Metal Bone Screw" is a medical device used for the fixation of various bone fractures. It is made of Ti-6A1-4V ELI (a titanium alloy).

Acceptance Criteria and Device Performance (Based on this document, these refer to mechanical and biocompatibility testing for a hardware device, not AI performance):

This document describes the regulatory process for a physical medical device (Metal Bone Screw), not a software or AI-driven device. Therefore, the "acceptance criteria" and "device performance" are established through non-clinical performance data (mechanical testing and biocompatibility testing) to demonstrate substantial equivalence to a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for a medical hardware device):

• Insertion/removal Test (per ASTM F543-17)
• Pullout Test (per ASTM F543-17) | Tests performed "to demonstrate substantially equivalent of safety and efficacy with the predicate device". (Implied successful performance to meet substantial equivalence, specific numerical results are not detailed here). |

Details Not Applicable to This Document (as it's a hardware device 510(k) not an AI study):

• Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical and biocompatibility testing of the physical device, not an AI test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth for a test set in the context of an AI device.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 for AI-assisted diagnostic devices.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI test set. For this hardware device, the "ground truth" for demonstrating substantial equivalence is established through adherence to recognized standards (ASTM) and a comparison of performance characteristics to a predicate device.
• The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

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Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).

The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies. Therefore, the typical information sought for AI/CADe devices (like ground truth establishment, reader studies, effect size with AI assistance, training set details, etc.) is not applicable here because this is a mechanical medical device, not an AI/CADe system.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by adherence to referenced standards and successful completion of specific mechanical tests. The reported device performance is simply "PASS" for all tested criteria, indicating it met the established benchmarks.

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

The document states "All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device." However, specific numerical sample sizes for each test are not provided. The provenance of the test samples (e.g., country of origin, retrospective/prospective) is also not specified, though it is implied these are manufactured device samples undergoing bench testing.

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 describes bench testing for a mechanical device. The "ground truth" here is determined by objective mechanical measurements against established ASTM and ISO standards, not expert interpretation of medical images or conditions.

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

This information is not applicable as the document describes bench testing for a mechanical device. There is no human adjudication process involved in these mechanical performance tests.

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 applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system.

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

The "ground truth" for the device's performance is established by objective mechanical measurements against recognized international standards (ASTM and ISO) for medical device performance (e.g., axial pullout strength, torsional yield strength, driving torque, degradation testing, fatigue).

8. The sample size for the training set

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system requiring a training set.

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

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system.

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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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The Sterile bone screw (PEEK ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery.

Knee

• · ACL repairs
• · PCL repairs
• Extra-capsular repairs
  • Medial collateral ligament
  • Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs - Vastus medialis obliquus advancement
• Iliotibial band tenodesis

The Sterile bone screw (PEEK ACL screw) is a bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of PEEK (poly-ether-ether-ketone, ASTM F2026).

The Sterile bone screw (PEEK ACL screw) is supplied gamma irradiation sterile state and it is packed in Tyvek Pouch.

The provided text describes the 510(k) summary for a medical device (Sterile bone screw (PEEK ACL screw)) seeking substantial equivalence to a predicate device. This document focuses on the mechanical and material performance of the medical device itself, rather than the performance of an AI algorithm or software.

Therefore, many of the requested elements for an AI/ML device approval (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the device's mechanical properties as presented in the document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly defined by the "PASS" result for each test conducted according to the specified ASTM standards. The study proves the device meets the acceptance criteria by indicating "PASS" for all relevant tests.

2. Sample Size and Data Provenance for Test Set

The document states: "All specimens selected (worst-case) to verify the performance of the screw met the test criteria." However, it does not specify the exact sample size (number of screws tested) for each test. The data provenance is a bench test, implying ex-vivo lab testing, not human patient data. There is no information regarding the country of origin of this specific test data, but the company is based in South Korea.

3. Number of Experts and Qualifications for Ground Truth

Not applicable as this is a mechanical device performance test, not an AI/ML algorithm requiring expert ground truth for interpretation of images or clinical data. The "ground truth" is established by the physical properties and performance of the screw itself, measured against established engineering standards.

4. Adjudication Method for Test Set

Not applicable. As this is a bench test for mechanical properties, there is no need for human adjudication of results in the traditional sense, beyond verifying that the test was conducted correctly according to the standard and the measurements fall within passing ranges.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, so no MRMC study was performed. The "improvement" measured is an engineering performance against a standard, not an improvement in human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering and medical device standards (ASTM and ISO standards) for material properties, mechanical performance, sterilization, and biocompatibility. The "worst-case" specimens were tested against these pre-defined, quantitative standards.

8. Sample Size for Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. As above, no training set for an AI/ML algorithm was used.

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The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.

The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.

The provided text does NOT contain information regarding the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a physical medical device called the "GEO Bone Screw System." It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K161904).

Therefore, I cannot provide the requested information. The document explicitly states:

"No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system."

This indicates that no new studies were conducted to prove this specific submission of the device met acceptance criteria, but rather it relies on prior testing of its predicate device and general design controls.

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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The subject devices are 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the predicate MobileLink® Acetabular Cup System (K182321).

This document (K192559) describes the 510(k) premarket notification for "Acetabular Bone Screws (for MobileLink Acetabular Cup System)". It's important to note that this document is for a medical device (bone screws), not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device does not apply to this submission.

The document discusses the substantial equivalence of the bone screws to predicate devices based on:

• Device Description: 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the MobileLink® Acetabular Cup System.
• Intended Use: The MobileLink® Acetabular Cup System (with which these screws are used) is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures, including primary and secondary osteoarthritis, rheumatoid arthritis, correction of functional deformities, avascular necrosis, femoral neck fractures, and revision after implant loosening.
• Comparison to Predicate Device: The subject screws provide supplemental screw fixation for acetabular shells, are manufactured from the same Ti6Al4V alloy as the predicate, are available in Ø 6.5mm and various lengths, and minor technological differences do not raise new questions of safety or effectiveness.
• Performance Testing (Non-Clinical):
  • Bone screw testing according to ASTM F543.
  • Endotoxin testing.
  • Biocompatibility evaluation.
• Clinical Testing: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Therefore, I cannot provide the requested information related to AI/software device acceptance criteria and study details because this document does not pertain to such a device.

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