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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Bone Screw Line Addition is intended to be used for the following indications:

• · Bone fractures
  • o Jones fractures
  • o Acute fractures
  • o Avulsion fractures
  • o Repetitive stress fractures
  • o Malleolar fractures
  • o Talus fractures
  • o Greater tuberosity fractures
    · Fixation of malunions and non-unions
• · Osteotomies
• · Arthrodesis

The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.

Based on the provided text, the device is a medical implant (Bone Screw Line Addition) intended for bone fixation, and the document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through clinical or analytical studies as one might find for an AI/Software as a Medical Device (SaMD).

Therefore, the provided document DOES NOT contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/SaMD. This document describes a physical medical device and its mechanical equivalence to existing devices.

The sections for AI/SaMD performance (e.g., sample sizes, expert ground truth, MRMC studies, training set details) are not applicable to this type of device and submission.

However, I can extract the information that is present and explain why the other requested information is not available in this document.

Acceptance Criteria and Device Performance (for a physical Bone Screw Line Addition)

Since this is a physical medical device (bone screw) and not AI/SaMD, the "acceptance criteria" are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, as assessed through engineering analyses.

• Acceptance Criteria: The device must demonstrate mechanical equivalence (e.g., torsional strength, shear strength, bending strength, pull-out strength) to the cleared predicate devices and not introduce any new questions of safety or effectiveness due to differences in technological characteristics (e.g., thread form, screw head geometry).
• Reported Device Performance: "Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength)."

Why the requested AI/SaMD information is not in this document:

This document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic/therapeutic device. The FDA's requirements for demonstrating substantial equivalence for a physical device like a bone screw typically involve:

• Comparison of technological characteristics: Material, design, mechanical performance, intended use.
• Performance data: Often bench testing (mechanical strength, durability) and sometimes biocompatibility testing.
• No clinical trials are usually required if substantial equivalence can be demonstrated through non-clinical means.

Therefore, the specific quantitative details about "acceptance criteria" and "study that proves the device meets acceptance criteria" as defined for AI/SaMD (e.g., sensitivity, specificity, AUC, human reader improvement) are not relevant to this submission type and are not present in the provided text.

Absence of Requested Information (Specific to AI/SaMD):

1. A table of acceptance criteria and the reported device performance: As explained above, for this physical device, the "acceptance criteria" are related to mechanical equivalence to predicates, not specific numerical diagnostic performance metrics. The performance is stated as "substantially equivalent mechanical strength."
2. Sample sizes used for the test set and the data provenance: Not applicable. No test set of patient data (e.g., images) was used for performance validation in the AI/SaMD sense. This involves mechanical testing or analyses, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for a bone screw.
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 not an AI-assisted device.
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.
8. The sample size for the training set: Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the FDA 510(k) clearance process for a physical medical device (bone screw) based on substantial equivalence principles, which are fundamentally different from the performance evaluation requirements for AI/SaMD.

Ask a specific question about this device

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 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 Hybrid 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 consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral 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 of a metal back/connector/glenosphere construct 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.

The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
• Revisions in cases of good remaining bone stock.

Bone screws are used to provide further stability to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration.

The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws.

The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used in both anatomic and reverse shoulder configuration; when used in reverse shoulder configuration, the metal back glenoid are intended for uncemented use and are fixed to the glenoid bone through the use of 6.5mm bone screws.

The current submission is for additional lengths of 6.5mm diameter bone screws:

• the proposed range of bone screws used in combination with the SMR Shoulder System is 20mm to 55mm in length;
• the proposed range of bone screws used in combination with the Delta TT Acetabular System is 15mm to 90mm in length.

Design, material, manufacturing process and intended use of the new 6.5mm diameter bone screws are the same as those for the 6.5mm bone screws cleared in the previous 510(k)s.

The provided document is a 510(k) premarket notification decision letter and accompanying information for Bone Screws 6.5mm by LimaCorporate S.p.A.

This document describes a submission for a medical device (bone screws), not an AI/ML-enabled diagnostic or therapeutic device that would typically undergo the kind of acceptance criteria, standalone performance studies, and human-in-the-loop studies involving expert readers, ground truth establishment, and large image datasets as outlined in your request.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets of images, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not present in this document.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• Non-Clinical Testing: "The additional lengths of 6.5mm bone screws use the same fundamental scientific technology and device design concepts, are made from the same materials utilizing the same manufacturing processes, utilize the same packaging and sterilization processes, and have the same indications for use as the predicate devices; the new lengths of 6.5mm diameter bone screws therefore do not require any testing to determine substantial equivalency."
• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of bone screws to the predicate devices."

This indicates that the FDA's substantial equivalence determination for these bone screws was based on their similarity to existing predicate devices in terms of design, materials, manufacturing, intended use, and indications, rather than requiring performance studies against specific acceptance criteria for diagnostic accuracy or clinical outcomes that would involve the elements you've listed.

In essence, the "study" proving the device meets acceptance criteria was a comparison to legally marketed predicate devices, demonstrating that the new bone screw lengths do not raise different questions of safety and effectiveness. The acceptance criteria for this type of device would primarily revolve around material compatibility, mechanical properties (which were not explicitly detailed as new testing data, given the stated substantial equivalence), manufacturing quality, and intended use as compared to the predicates, rather than the performance metrics of an AI/ML system.

Ask a specific question about this device

Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.

Not Found

The provided text is a 510(k) clearance letter from the FDA for Bone Screws, Kirschner Wire, and Steinman Pins. It states that these devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not involve the kind of detailed study data and acceptance criteria that would be found for a novel medical device requiring de novo classification or PMA.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such studies were not required for this specific 510(k) clearance. The FDA's determination here is based on the devices being "substantially equivalent" to existing, legally marketed predicate devices, not on new performance data demonstrating meeting specific, novel acceptance criteria through a clinical or performance study of the type usually associated with AI/software devices.

Ask a specific question about this device