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The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient.

Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.

The system is not intended for spinal use.

The I.T.S. LRS (Locking Reconstruction System) consisting of the DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) are fracture fixation plating systems for repairing long bone factures located in the distal femur and proximal tibia in the human body. The DFL Plates consist of three plate lengths of 5, 9, & 13 hole pre-contoured shape in a left/right configuration to fit the distal femur and the PTL Plates consist of three plate lengths of 7, 12, & 17 hole precontoured shape in a left/right configuration to fit the proximal lateral tibia. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers an extramedullary, internal fixation system, minimal bone contact, and a locked fixed-angle construct using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in a 5.9mm cancellous and 4.5mm cancellous/cortical sizes are offered. All screws are self-tapping for insertion into bone. The design intent of the aiming guide instrumentation allows the surgeon to prepare percutaneous targeting of screws through 'minimal invasive' stab incisions. This aiming guide instrument ensures that all targeted screws will be properly inserted and locked to the plate. The aiming guide instrumentation is radiolucent to allow offset (90 degree) fluroscopy evaluation in bone fragment reduction of the fracture site and confirmation of screw engagement into the plate. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plate and the introduction of multiple sizes of locking/nonlocking screws as needed for stabilizing the fracture - when using x-ray fluroscopy.

All I.T.S. LRS - DFL & PTL plates and screws are processed with a TIODIZE II surface treatment. A full compliment of instrumentation is available for use with the system.

The provided text describes a 510(k) Summary for the I.T.S. LRS Locking Reconstruction System, a medical device for fracture fixation. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: Details of the DFL and PTL plating systems, materials, screw types, and instrumentation.
• Intended Use: Specifies the types of fractures and patient populations (pediatric and adult) for which the system is designed.
• Equivalence: States that the device is substantially equivalent to several predicate devices.
• Summary of Safety and Effectiveness: A general statement about its safety and effectiveness.
• Regulatory Information: FDA review and determination of substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

To address your request, the input document would need to include sections detailing:

• Specific performance metrics the device is designed to achieve (acceptance criteria).
• A description of a study (e.g., mechanical testing, clinical trial) that evaluates these metrics.
• Data from that study comparing observed performance to the acceptance criteria.
• Information on study design, sample sizes, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or standalone performance).

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The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.

The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.

The provided text is a 510(k) summary for the I.T.S. CONNEXX Locking Tibia Nail. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead of performance criteria and a study to prove it, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical device approval in the United States, where a new device is shown to be as safe and effective as a predicate device already on the market, rather than necessarily performing a specific quantitative benchmark study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: No specific test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proof" and "acceptance":

The "proof" for this device's safety and effectiveness, as per the 510(k) process, is its substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly that the device's design, materials, and intended use are comparable to these predicate devices.

Basis of Substantial Equivalence (from the text):

• "The I.T.S. CONNEXX Locking Tibia Nail is substantially equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems."
• The comparison likely involves:
  • Intended Use: The indications for use are very similar to those of the predicate devices.
  • Technology/Design Principles: It's an intramedullary rod with locking/nonlocking cross-screw fixation, a common design for such devices.
  • Materials: High strength 6-4 ELI Titanium Alloy (ASTM F-136) is a standard material for orthopedic implants.
  • Performance Characteristics: While not explicitly detailed, the equivalence would imply that its mechanical performance (e.g., strength, fatigue resistance) is comparable to the predicate devices, likely demonstrated through bench testing as part of the 510(k) submission (though not described in this summary).

Conclusion:

This 510(k) summary does not describe a study with explicit acceptance criteria and device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it leverages the concept of substantial equivalence to predicate devices as its primary justification for safety and effectiveness. The "acceptance criteria" are met by demonstrating that the new device is sufficiently similar to already approved devices.

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The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.

Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fixation plating system for repairing factures located in the distal area of the humerus in the elbow (in the area of medial and lateral epicondyles of the distal humerus). The Distal Humeral Plates consist of two plate designs as a medial (8 hole) and dorsolateral (5 hole) left and right plate configuration - anatomically pre-contoured to fit the distal humerus human anatomy and manufactured from Commercialy Pure (CP) Titanium material for minor intra-operative forming by the surgeon. The offset opposite location of the plates on the medial and lateral epicondyles provide a girder-like construct for difficult bone fracture reconstruction stability. The added benefit of locking screws within each plate and up to a +- 15° angle position allows a fixed-angle contruct of screw-to-plate and offers angle-flexibility in screw positioning for further optimal fracture stability. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plates and introducing multiple sizes of locking/non-locking screws as needed for stabilizing the fracture(s) - when using optional x-ray fluroscopy. The system offers a 3.5mm locking and non-locking cortical screw and a 4.2mm locking cancellous screw in multiple lengths manufactured from High Strength 6-4 Alloyed Titanium material. All plates and screws are processed with a TIODIZE II surface treatment - which improves the material surface hardness and biocompatibility to adjacent tissues. The low-profile and contoured left and right plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.

I am sorry but the provided text does not contain information about acceptance criteria, device performance results, or a clinical study. The document is a 510(k) summary for a medical device (Distal Humeral Plates with Angular Stability) seeking marketing clearance based on substantial equivalence to predicate devices, not on direct performance against acceptance criteria from a study. It outlines the device description, intended use, and substantial equivalence to legally marketed devices. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.

Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.

The system is not intended for spinal use.

The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate is made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a medical device, the I.T.S. Fibula Plate PROlock with Angular Stability, and its 510(k) summary for clearance by the FDA. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices, not on demonstrating specific performance metrics against defined acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or an MRMC study based on the provided text.

Here's why and what information is present:

• Acceptance Criteria and Reported Device Performance: This information is completely absent. The document is about regulatory clearance based on substantial equivalence, not performance testing.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of this is mentioned. The clearance is based on the device's design, materials, and intended use being similar to already marketed devices. The document does not describe a clinical study in the way you've outlined.

Information that is available in the provided text:

• Device Name: I.T.S. Fibula Plate PROlock with Angular Stability
• Intended Use/Indications for Use: Titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula, including metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions, corrective osteotomy, and open and closed fractures. Not intended for spinal use.
• Materials: Plate from CP Titanium (ASTM F 67-00), screws from 6-4 Alloyed Titanium (ASTM F 136-02).
• Regulatory Pathway: 510(k) premarket notification.
• Substantially Equivalent Devices (Predicates): Synthes Semi-Tubular Plate, Synthes Small Fragment System, Synthes 4.5mm LCP Straight Reconstruction Plates, Synthes LCP Distal Tibia Plates, Synthes One-Third Tubular DCL Plate, Synthes Curved Reconstruction Plate, Synthes Medial Distal Tibia Plates, Zimmer Periarticular Plating System, Acumed Lower Extremity Congruent Plate System.

In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a report on a study demonstrating performance against acceptance criteria.

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The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.

Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include:

1. Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
2. Revision surgery of pseoduarthroses, non-unions and mal-unions,
3. Ilio-Iliac distance osteosynthesis,
4. Osteotomies,
5. Arthrodesis,
6. Sacroiliac joint dislocations, and
7. Symphysis pubis disruptures

Indications for use of the I.T.S. PRS Sacral Rod System include:

1. Fixation of fractures of the posterior pelvis,
2. Fixation of fractures of the posterior iliac spine,
3. Fixation of fractures of the posterior inferior illac spine,
4. Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
5. Fixation of sacral fractures, and
6. Fracture dislocations of the sacro-iliac joint

Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies.

The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.

The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number of fracture fixation subsystems (multiple pelvic plate designs, sacral threaded rod, and cannulated screw & washer) for facture fixation and reconstruction of pelvic ring fractures in the pelvis.

The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System consists of the following plate types: 1) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a 108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16 hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a 4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a 2.5mm thickness in a 4 hole size.

All plate designs are low profile in thickness and made from CP of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation.

This document is a 510(k) summary for a medical device called the Pelvic Reconstruction System (PRS). It does not contain information about studies proving the device meets acceptance criteria for a medical device that analyzes data or images. This is a submission for a physical implantable device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as these elements are not relevant to the type of device and submission described in the provided text.

The document primarily focuses on:

• Device Description: What the Pelvic Reconstruction System is and its components (plates, screws, sacral rod).
• Intended Use/Indications for Use: The medical conditions and procedures for which the device is designed to be used (e.g., stabilizing pelvic bone fractures, revision surgery, osteotomies).
• Substantial Equivalence: A comparison to existing, legally marketed devices to demonstrate that the new device is as safe and effective. This is the primary basis for clearance for this type of device.

No information regarding algorithm performance, reader studies, AI assistance, or data-driven acceptance criteria is present.

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The intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient.

Indications for use include comminuted fractures, supercondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones: treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may be used only on small bones.

The intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient.

For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the Ileosacral joint, and fusion of the foot and ankle.

For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibiaplateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the Ileosacral joint, and metaphyseal fractures of the distal femur and distal tibia.

The system (s) is not intended for spinal use.

The I.T.S. Straight Plate with Angular Stability is a low-profile 4, 6, or 8 hole plate with various length cortical and/or cancellous self-tapping stabilization locking and/or compression screws. The Straight Plate is made from CP titanium according to ASTM F 67-00 and all screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The I.T.S. Screw System is a group of cannulated fracture fixation screws in various diameters of 4.0mm, 6.5mm, and 7.3mm and lengths. A complement of flat and spherical Washers are available with the system. All screws and washers are made from 6-4 Alloyed Titanium according to ASTM F 136-02 and are surface conditioned with a TIODIZE, Type II preparation.

The provided text is a 510(k) Summary for a medical device (Straight Plate with Angular Stability & Screw System). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states: "The I.T.S. Straight Plate with Angular Stability and Screw System is shown to be safe and effective for use in fracture fixation of small and long bones in the body." This is a general statement of conclusion and not a detailed report of how safety and effectiveness were demonstrated against specific acceptance criteria through a study.

Therefore, I cannot provide a response filling in the requested table and details because the necessary information is not present in the provided text.

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The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon).

The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Olecranonplate with Angular Stability." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

Specifically, the text includes:

• Device Description: The I.T.S. Olecranonplate with Angular Stability is a low-profile universal titanium plate with various length cancellous self-tapping and head locking stabilization screws, and cortical screws. It is made from CP titanium and 6-4 alloyed titanium.
• Intended Use/Indications for Use: Fixation of complex intra- and extra-articular fractures, osteotomies, nonunions, malunions, and various types of simple and complex fractures of the proximal ulna (olecranon).
• Basis of Substantial Equivalence: It is substantially equivalent to Acumed Olecranon Plate, Synthes Curved Reconstruction Plate, and Zimmer Zuelzer Hook Plate for fracture of the Olecranon.
• Summary of Safety and Effectiveness: States that the device is "shown to be safe and effective for use in fracture fixation of the proximal ulna (olecranon) in the elbow," but does not provide details of any study or acceptance criteria used to demonstrate this.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study's methodology as this information is not present in the given text.

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The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.

Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.

This system is not intended for spinal use.

The I.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation across calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate (universal left and right in 2 sizes) is made from CP titanium according to ASTM F 67-00 and corresponding plate locking and self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed titanium according to ASTM F 136-02. The fully threaded 7.3mm Cannulated Cancelous Screw is in various lengths from 50 to 90mm in 5mm increment sizes and is also made from 6-4 alloyed titanium according to ASTM F 136-02. All titanium plates and screws are surface conditioned with a TIODIZE, Type II preparation

The provided document is a 510(k) summary for the "FR.O.H. Calcaneus Repair System," a bone plate and cannulated cancellous bone screw system. However, this type of regulatory submission (from 2005) does not contain the detailed study information regarding acceptance criteria and performance metrics typically found for AI/ML-based devices.

This document describes a traditional medical device (implants for bone fracture fixation) and not an AI/ML-based device that would require such performance studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to pre-existing devices through material composition, design, and intended use, rather than through performance metrics of a device's "performance" in diagnosing or treating conditions based on data analysis.

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The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.

The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a medical device, the "Pilonplate with Angular Stability," and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance study results against specific criteria.

Therefore, I cannot populate the requested table and answer questions 2 through 9 based solely on the provided text. The document confirms:

• Device Name: Pilonplate with Angular Stability
• Intended Use: Fixation of complex intra- and extra-articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
• Substantial Equivalence: The basis of substantial equivalence is to Synthes, DePuy/ACE, Link America, and Zimmer bone plate systems.
• Claim of Safety and Effectiveness: "The I.T.S. Pilonplate with Angular Stability is shown to be safe and effective for use in fracture fixation of the distal tibia in the leg." However, no study data or acceptance criteria are presented to support this claim in this document.

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The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a 510(k) premarket notification for a medical device called the "Humeral Head Plate with Angular Stability." This document focuses on demonstrating the device's substantial equivalence to previously approved devices, rather than conducting a de novo study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study details, and AI-related performance metrics is not directly present in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which means it aims to demonstrate substantial equivalence to predicate devices already on the market. The provided text doesn't define specific quantitative acceptance criteria for performance; instead, it focuses on the device's design, materials, and intended use being similar to existing, legally marketed devices. Therefore, a table of acceptance criteria and reported device performance as would be found in a performance study is not available here.

• Sample Size for Test Set and Data Provenance: Not applicable, as this is not a clinical performance study with a test set of data. The document focuses on regulatory approval based on equivalence.

• Number of Experts and Qualifications: Not applicable. There is no information on expert review for ground truth establishment for a test set.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done or is described. The device is a bone plate, so AI assistance for human readers is not relevant in this context.

• Standalone (Algorithm Only) Performance: Not applicable. This is a physical implant, not an AI algorithm.

• Type of Ground Truth Used: Not applicable, as there's no performance data being evaluated against a ground truth.

• Sample Size for Training Set: Not applicable. There is no AI model or training set involved.

• How Ground Truth for Training Set Was Established: Not applicable.

However, based on the information provided, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission:

1. Acceptance Criteria (for 510(k) Substantial Equivalence):

2. The "Study" (in the context of 510(k)):

The "study" that proves the device meets the acceptance criteria is the 510(k) Premarket Notification process itself, specifically the provided Summary of Safety and Effectiveness. In this context, the "study" is a comparative assessment against legally marketed predicate devices, and it relies on non-clinical data (e.g., material testing, mechanical testing, design comparisons, and adherence to recognized standards for bone plates).

• Data Provenance: The nature of a 510(k) implies that the "data" is primarily based on engineering analysis, material specifications, and comparative design reviews against established predicate devices. There is no mention of clinical data or patient outcomes in this summary. The materials comply with ASTM standards (F 67-00, F 136-02), indicating adherence to recognized engineering and material specifications.
• Ground Truth: For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness profile of the predicate devices. The new device aims to demonstrate that it is as safe and effective as these already approved devices.
• Sample Size for Test/Training set & Ground Truth Establishment: These concepts are not directly applicable since this is a regulatory submission for a physical implant based on substantial equivalence, not a clinical trial or an AI performance study. The "evidence" is the comprehensive documentation submitted to the FDA demonstrating that the device is comparable to predicates in terms of intended use, technological characteristics (materials, design), and performance (implied by material and design similarity, and adherence to standards).

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