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The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.

The provided text is a 510(k) premarket notification letter and summary for the "OIC Small / Mini Fragment Plate System," which is a metallic bone fixation appliance. This document is a regulatory submission for a physical medical device, not a software-based AI/ML device.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device (e.g., acceptance criteria for AI performance metrics like diagnostic accuracy, sensitivity, specificity, AUC; sample sizes for test sets in AI studies; number of experts for ground truth establishment; MRMC studies; standalone algorithm performance; training set details) is not applicable to this submission.

The "Performance Testing" section in the document describes mechanical testing of the plates and screws (bend testing, torsional strength, driver torque, axial pullout strength) according to ASTM standards (F382 and F543). These tests are designed to demonstrate the physical and mechanical integrity and equivalence of the device to predicate devices, which is standard for orthopedic implants.

In summary, this document does not contain the type of information requested for a study proving an AI/ML device meets acceptance criteria.

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The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.

The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.

I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the OIC Suture Anchor System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, as typically described for AI/ML-based medical devices.

This document is for a traditional, physical medical device (suture anchor system) and primarily establishes substantial equivalence to predicate devices based on:

• Indications for Use: The OIC Suture Anchor System is intended for fixation of soft tissue to bone and supports specific procedures (Shoulder, Elbow, Knee).
• Technological Characteristics: It compares the OIC device's design (PEEK plastic anchors, eyelet, screw-like) and materials (PEEK, stainless steel, aluminum for instruments) to predicate devices.
• Performance Testing: It briefly mentions "Mechanical testing was conducted to ascertain that the suture acceptable characteristics for the intended uses." This is a general statement and does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for the specific information points related to acceptance criteria and a study proving device performance, especially in the context of AI/ML devices (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) from the provided text.

The document details the FDA's clearance process for physical devices, focusing on substantial equivalence, rather than the rigorous performance validation typically required for AI/ML algorithms.

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The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nay be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.

The OIC Intramedullary Nail System consists of the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lad screws are 10.5mm in diameter and range in length from 70mm to 120mm.

The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI.

The additional instruments being added to the OIC Intramedullary Nail System are provided in the non-sterile condition. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle.

This document, K181184, is a 510(k) premarket notification for the OIC Intramedullary Nail System, which is a Class II medical device (Product Code HSB) used for surgical management of femoral and tibial fractures.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm.

The document discusses the addition of fifteen instruments to an existing OIC Intramedullary Nail System (primary predicate device K150655). The substantial equivalence claim is based on:

• Intended use: The new instruments support the existing intended use of the OIC Intramedullary Nail System.
• Materials: The instruments are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle, which are standard materials. The nails, bolts, and screws are made of titanium alloy Ti-6Al-4V ELI.
• Function: The added instruments aid in installing or extracting parts of the system, including tools for suprapatellar insertion of tibial nails.
• Mechanical characteristics: "The instrument constructs were found to have acceptable mechanical characteristics for the intended uses." This implies some form of testing, likely mechanical bench testing, but the details of the acceptance criteria and study are not provided in this document.

The "study" mentioned for establishing substantial equivalence refers to a geometric comparison to predicate devices and evaluation of mechanical characteristics, not a clinical study involving AI/ML performance metrics.

Therefore, I cannot populate the requested information regarding acceptance criteria and an AI/ML study because this document does not contain that type of information. It's a regulatory submission for a traditional orthopedic implant system, not a software as a medical device (SaMD) or an AI-enabled device.

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The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.

The Cervical PEEK Spacer is a polyetherether cervical interbody fusion spacer. The device comprises a closed annular ring and hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces and expulsion. The device includes a radiopaque marker pin position wall of the device. The device is offered in two footbrints (depth x width, 9.5mm x 15mm), one lordotic angle (7°) and heights ranging from 6mm to 10mm in 1mm increments.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical study acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth methods typically associated with such studies.

Instead, this document pertains to a physical medical device, the "OIC Cervical PEEK Spacer," which is an intervertebral body fusion device. The FDA's review determines if it is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs similarly in non-clinical tests.

The "Performance Testing" section mentions:

• Static axial compression
• Dynamic axial compression
• Static torsion testing per ASTM F 2077-03
• Subsidence testing per ASTM F 2267-04

These are mechanical engineering tests for a physical implant, not clinical trials or diagnostic performance studies for an AI algorithm. The conclusion states that the device was found to have "acceptable mechanical characteristics for the intended uses," but this is based on engineering standards, not clinical performance against acceptance criteria in the context of an AI study.

Therefore, I cannot provide the requested information because the document does not contain data related to an AI/ML powered device or a study structured to meet clinical acceptance criteria for such a device.

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a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
b. Clavice plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicie.
c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.

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I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding orthopedic plating systems. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details related to proving a device meets acceptance criteria. The document only confirms the substantial equivalence of the OIC Distal Radius Plating System, OIC Proximal Humerus Plating System, and OIC Clavicle Plating System to legally marketed predicate devices.

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a. OIC Cannulated Screw System is used for adult and pediatric patients as indicated for pelvic, small and longbone fracture fixation. OIC 6.5/7.3mm cannulated screws are indicated for large bones and large bone fragments such as ankle arthodeses, intercondylar femur fractures, pediatric femoral neck fractures (6.5mm cannulated screws only), sacroiliac joint disruptions, and subtalar athrodeses. OIC 4.0mm cannulated screws are indicated for the fracture fixation of small bones and small bone fragments such as metatarsal and phalangeal osteotomies, fractures of the tarsals and metatarsals, tarsometatarsal and metatarsophalangeal athrodeses, osteochondritis dissecans, and other small fragment cancellous bone fractures.
b. The OIC Sliding Hip Screw (SHS) System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in subtrochanteric, intertrochanteric, and basilar neck fracture. The SHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The SHS provides controlled collapse and compression of fracture fragments. This results in stable fixation and prevents undue stress concentration on the implant.

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This FDA 510(k) clearance letter pertains to medical devices (OIC Cannulated Screw System and OIC Sliding Hip Screw System), not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria and a study to prove the device meets those criteria (especially points related to AI/ML performance metrics, ground truth, experts, and training/test sets) is not applicable to this document.

The document primarily focuses on the substantial equivalence determination for orthopedic implants, referencing regulations like 21 CFR 888.3030 and product codes KTT, HWC. This type of clearance is based on comparison to legally marketed predicate devices, and the evaluation does not typically involve the kinds of performance studies, expert consensus, or training/test set analyses relevant to AI/ML device submissions.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the primary route for clearance, which is historical comparison.

Therefore, I cannot provide the requested table and study details as they are not present or relevant in the provided document.

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