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OsteoSorb® Tack Fixation System: The OsteoSorb® Tack Fixation System is intended for fractures of craniofacial skeleton Including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital area, molding, but not minted to, continuenus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skcleton. The OsteoSorb® Tack Fixation System procedures of the initiate of enamers in with appropriate postoperative immobilization. The OsteoSorb® Tack Fixation System stabilizes bone during healing in conjunction with The Osteood bo Tack I Banon Officiation. The Osteomedics® Resorbable Tack Fixation System appropriate postoperative intinocinations includicated for: 1) Significant comminuted fractures or area with active infection. 2) Patient conditions including: blood supply limitation, insufficient with active intections 27 ratest infections and where patient co-operation can not be guaranteed (e.g. alcoholism). 3) Mandibular tumor resection. 4) Intermaxillary fixation without an appropriate external fixation by other means. 5) This device is not designed for use in the an appropriate excerner matuences of encessedures.6) when time to healing is anticipated to be mandlot of for use in four outlent has a history of adverse reaction to resorbably materials (e.g. resorbable sutures).

OsteoSorb® Smooth Pin Fixation System: The OsteoSorb® Smooth Pin Fixation System intended for use in the presence of appropriate immobilization for the internal fixation of fractured non-load bearing bones, osteotomies and arthrodeses, for example in fixation of apical fragments, osteochondral fragments and cancellous / non-load bearing fragments. Correction of hallux valgus and repair of metacarpal and phalageal fusion and fracture. The OsteoSorb® Pin Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. Use is contraindicated in case where conservative (closed) treatment is appropriate, where pressure osteosynthesis is desired, where fragments are subjected to tension stress, when time to healing is anticipated to be greater than six weeks, when patient has a history of adverse reaction to resorbable materials (e.g. resorbable sutures), when use of the device without appropriate postoperative immobilization, when fractures and osteotomies is in weight bearing bone, where internal fixation is otherwise contraindicated, e.g., insufficient quantity or quality of bone and where patient co-operation carnot be guaranteed (e.g. alcoholism) where significant communuted fractures or area with active infection, Federal (USA) laws restrict this device to sale or on the order of a physician.

The Noviace HeatingPen: The Noviace HeatingPen is used for plate bending and cutting plate, screw tip and pin. The Heating Pen device enables to mold in-situ OsteoSorb Plates to varying skeleton morphologies.

The NOVIACE HeatingBath: The Noviace HeatingBath is used to shape intra-operatively the OsteoSorb® Plate and Mesh.

OsteoSorb® Tack Fixation System: Consists of resorbable tacks and accessory instruments, which are additional components of the Osteomedics® Resorbable Small Fixation System OsteoSorb® (K022035). Resorbable tacks are available in 1.5 mm diameter and in lengths ranging from 4-8 mm. The emergency tack system consists of 1.7 mm in diameter. The OsteoSorb® Tack Fixation System are similar in design to the standard screw in the Osteomedics® Resorbable Small Fixation System OsteoSorb® (K022035) however the tacks are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. An instrument set consists of crossbow type inserter and bone drill. Basic elements are the drilling of hole for the tack, which is completely the same step than with the conventional screws. Then the tack is pushed into hole with inserter. There is no need for tapping the hole and screwing like with the conventional screws. The material for the OsteoSorb® Smooth Pin Fixation System is Poly (L/DL-Lactide).

OsteoSorb® Smooth Pin Fixation System: Consists of a series of bioabsorbable pins in various length and diameters are, 1.3.1.5.2.0 and 3.2 mm with lengths of 10, 20, 30, 40, 50, 60 and 70 mm The pin can be shortened intra-operatively to as little as 10 mm. The material for the OsteoSorb® Smooth Pin Fixation System is Poly (L/DL-Lactide).

The Noviace HeatingPen: The Noviace HeatingPen is a single-use, cordless and battery operated. Three (3) tips are provided - a cautery tip which is used to cut plates, screw tips and pins, a long malleable plate tip, and a short fixed plate tip, both of which will bend plates in-situ.

The NOVIACE HeatingBath: The Noviace™ HeatingBath is consisting of heating unit and auxiliary pan, which are fabricated from PolarWare 304 Stainless Steel. The heating unit sold non-sterilized but the auxiliary pan is sold sterilized.

This document is a 510(k) summary for the OsteoSorb Tack and Pin Fixation System and the Noviace HeatingPen and HeatingBath. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove that the device meets specific acceptance criteria through a clinical study.

Therefore, the input does not contain the kind of detailed information about acceptance criteria and a specific study proving those criteria, as requested in the prompt. Instead, the summary focuses on describing the devices, their intended uses, and comparing them to existing legally marketed predicate devices.

Based on the provided text, I cannot answer the questions directly as the information required for a clinical study proving acceptance criteria is not present.

Here's why and what information is missing:

• Acceptance Criteria & Reported Performance: A 510(k) submission typically compares the new device to a predicate device in terms of design, materials, intended use, and performance claims. It does not usually present "acceptance criteria" in the sense of predefined performance metrics from a large-scale study, nor does it typically report "device performance" with statistical measures like sensitivity, specificity, or AUC as one would expect from an AI/diagnostic device study. The performance is implied by demonstrating substantial equivalence to the predicate.
• Sample Size for Test Set & Data Provenance: This information would be relevant for a clinical study, which is not described.
• Number of Experts & Qualifications: Not applicable as there's no diagnostic performance study involving human readers or ground truth adjudication.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned, as this is typically for diagnostic devices where AI assists human readers.
• Standalone Performance Study: Not mentioned, as this is typical for diagnostic AI algorithms.
• Type of Ground Truth: Not applicable, as there's no diagnostic evaluation on patient data.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These are entirely irrelevant for a medical device fixation system and heating tools approval. This information is specific to AI/ML device development and evaluation.

In summary, the provided content is a 510(k) summary for a set of surgical fixation devices and their associated heating tools. It focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a set of acceptance criteria through a clinical study in the manner an AI or diagnostic device would be evaluated.

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The Normed Compression Bone Screw System intended for use for fractures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to functionally stable osteosynthesis such as, but not limited to scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger eng and metacarpal joints and fractures of ulna head and radius head.

The Normed Compression Bone Screw System is a headless screw with double self-tapping cancellous bone thread that is designed for dynamic adjustable intarfragmentary compression purposes. The pitch of the thread in the proximal segment is smaller than the thread pitch at the distal end. The compression force is produced due to the difference in pitch between the distal and proximal segments. The Normed Compression Bone Screw System consists of three systems. Mini System 1.5. Standard System 2.0 and High Compression System 2.0. The Mini System 1.5 may be placed using an open approach with the use of a target bow device for placement of the screw. The Standard System 2.0 and High Compression System 2.0 are cannulated and may be placed through percutaneous screw placement using K-wire as a guide in minimize the incision. All three systems are available in10 through 30 mm length.

The provided text is a 510(k) summary for a medical device called the "Normed Compression Bone Screw System." It describes the device, its intended use, and the FDA's determination of substantial equivalence. However, it does not contain any information about acceptance criteria, performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) device performance.

Therefore, I cannot fulfill your request for the detailed table and study information because the input document does not provide the necessary data.

To clarify, here's what the document does contain:

• Identifies the device: Normed Compression Bone Screw System (bone fixation plate/screw).
• Device classification: Class II, 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories).
• Intended Use/Indications: Fractures or arthrodesis of various bones (carpals, metacarpals, radial head, metatarsals, etc.) and corrective osteotomies.
• FDA determination: Substantial equivalence to a legally marketed predicate device.
• Contact information for the manufacturer.

It does not include:

• A table of acceptance criteria.
• Reported device performance data against acceptance criteria.
• Details of any study (sample size, data provenance, ground truth, number of experts, adjudication method, MRMC study, standalone study, training set information).
• Any mention of AI, machine learning, or software performance.

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