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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.

The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.

The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.

The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:

• Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
• Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
• Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.

In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.

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The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.

The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.

The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The provided text describes the regulatory clearance for the "OSTEOMED ExtremiFuse System" and does not contain information about an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence, which is a different type of evaluation from an AI/ML model.

Here's the information based on the document:

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

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 does not specify a "sample size" for a traditional clinical "test set" in the context of an AI/ML device. Instead, it refers to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "The ExtremiFuse implants underwent verification..." and references "pullout test, and bending test." It does not provide the number of implants tested.
• Data Provenance: Not applicable in the context of clinical data. This refers to mechanical performance testing of the device itself.

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)

Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images or diagnoses) was not established for this type of device submission. The "ground truth" here is adherence to mechanical performance standards and achieving substantial equivalence to predicate devices.

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

Not applicable. There was no clinical assessment requiring adjudication by multiple experts. The evaluation was based on mechanical testing and comparison to predicate devices.

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. An MRMC comparative effectiveness study is designed for AI/ML devices involving human readers. This submission is for a physical orthopedic implant and does not involve AI/ML or human readers in that capacity.

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

Not applicable. This device is not an algorithm or AI system. It is a physical implant.

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

The "ground truth" for this device's evaluation was based on:

• Mechanical performance standards: The device's physical properties (e.g., strength, durability in pullout and bending tests) were verified against established criteria for its intended use.
• Comparison to predicate devices: The device's design, materials, function, and performance were compared to already legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. No AI/ML model was trained.

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

Not applicable. No AI/ML model was trained.

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The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.

This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, modified to address the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
• Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.

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

Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate device.

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.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.

8. The Sample Size for the Training Set

Not Applicable. No training set for an algorithm is involved.

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

Not Applicable. No training set for an algorithm is involved.

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The CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:

• · Midfoot and hindfoot arthrodeses or osteotomies
• · Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)
• · Intercuneiform arthrodeses
• · Naviculocuneiform arthrodeses
• · Talonavicular arthrodeses
• · Calcaneocuboid arthrodeses
• · Lisfranc arthrodeses
• · Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
• · Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
• · Akin osteotomies
• · First metatarsophalangeal arthrodeses

The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

The provided text describes a 510(k) premarket notification for the CLAW® II Polyaxial Compression Plating System, demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria with performance metrics. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted or are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of specific, measurable acceptance criteria and corresponding performance data. The device demonstrates "substantial equivalence" to predicate devices through non-clinical testing.

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

• Sample Size: Not specified for any test sets. The document describes "worst-case plate analysis, plate mechanical testing, and polyaxial performance testing," but does not detail the number of samples or specimens used in these tests.
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer, Wright Medical Technology, Inc. There is no information on country of origin of data or whether it's retrospective or prospective, as these terms usually apply to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is cleared based on non-clinical substantial equivalence, not on expert-adjudicated ground truth from a clinical data set. The "ground truth" here is the performance of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no external experts were used to establish a ground truth for a clinical test set. The determination of substantial equivalence was made by the FDA based on the presented non-clinical evidence.

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/software device, but a physical orthopedic plating system. No MRMC studies or AI involvement are mentioned.

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 or AI.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The subject device's performance (mechanical, polyaxial performance) was assessed to be "at least as well as" the predicate devices. The ground truth for the predicate devices themselves would have been established through their original clearance processes, likely including non-clinical testing and potentially clinical data depending on their classification and introduction date.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable, as this is not a machine learning or AI device that requires a training set with established ground truth.

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The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.

Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance data. It mentions that "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures," suggesting real-world data from Europe, but this is not a formal "test set" in the context of a controlled study.

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

This information is not provided in the document. The data presented is primarily non-clinical "performance data" such as testing against industry standards, biocompatibility, and mechanical properties, rather than data requiring expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical performance data (e.g., mechanical testing against standards).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data and a comparison of technological characteristics to predicate devices.

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

This is not applicable as the device is a medical implant (plates, screws, and pins), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is established by:

• Industry Standards: Compliance with established international and national standards (ISO 5838, ASTM F366-04, ASTM F0543-07, ASTM F 382-99).
• Predicate Device Performance: Direct comparison of functional and mechanical properties against legally marketed predicate devices.
• Biocompatibility Testing: Results of established biocompatibility tests.

There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) in the context of a clinical study for this 510(k) summary.

8. The Sample Size for the Training Set

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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