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The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OSTEOMED ICON Modular Locking Fixation System implants and drills are intended for single use onlv.

The OSTEOMED ICON Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of maxillofacial and mandibular fractures. The screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard non-locking screws, safety screws and Auto-Drive™ screws, as needed.

The system features three modular blocks.

• . The 1.6mm Midface System consists of 1.6mm locking standard screws with lengths ranging from 3mm to 14mm, 1.6mm locking Auto-Drive™ screws with lengths ranging from 4mm to 8mm and 1.9mm safety screws with lengths ranging from 3mm to 1.6mm midface plates range in thicknesses of 0.6mm to 0.8mm.
• . The 2.0mm Midface/Mandible System consists of 2.0mm locking standard screws with lengths 4mm to 18mm, 2.0mm locking Auto-Drive™ screws with lengths of 4mm to 8mm, and 2.3mm safety screws with lengths ranging from 4mm to 24mm. The midface plates range in thicknesses of 0.6mm to 0.8mm and the mandible plates range in thicknesses of 1.0mm to 1.5mm.
• The 2.8mm Mandible System consists of 2.0mm locking standard screws with lengths 6mm to 22mm, 2.4mm locking Auto-Drive™ screws with lengths of 6mm to 8mm, and 2.7mm safety screws with lengths ranging from 6mm to 22mm. The fracture plates range in thicknesses of 1.0mm to 1.5mm and the reconstruction plates range in thicknesses of 2.0mm to 2.8mm.

The instruments include drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates.

The document describes the OsteoMed ICON Modular Locking Fixation System, which is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction. The device is being compared to its predicate device, the OsteoMed Modular Locking Fixation System (K080694).

Here's an analysis of the provided information, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it describes a "verification evaluation" to ensure the new device meets "required mechanical strength criteria" that are equivalent to the predicate device.

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

The document states that "The OsteoMed ICON Modular Locking Fixation System 2.8mm plates were compared to the OsteoMed 2.5mm Modular Locking Fixation System plates, K080694."

• Sample Size for Test Set: The exact sample size (number of plates/screws tested) for the "verification evaluation" is not specified in the provided text. It only mentions the 2.8mm plates of the ICON system being compared to the 2.5mm plates of the predicate device.
• Data Provenance: The study described is a non-clinical performance evaluation (mechanical testing), not a clinical study involving human data. Therefore, data provenance in terms of country of origin or retrospective/prospective does not apply in the typical sense. It's an internal engineering verification study.

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

This information is not applicable as the study is a non-clinical mechanical performance evaluation, not a study requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a non-clinical mechanical performance evaluation.

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

This information is not applicable. This document describes a medical device (bone fixation system), not an AI/software device that involves human readers or AI assistance. The study is a non-clinical mechanical performance evaluation.

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

This information is not applicable. This document describes a medical device (bone fixation system), not an AI/software device. The study is a non-clinical mechanical performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical strength criteria for the intended use of bone fixation plates. This "ground truth" is derived from engineering principles and standards relevant to the type of device and its intended application. The device's performance was compared against these criteria and the performance of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. This describes a mechanical device, not a machine learning model that requires a training set.

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

This information is not applicable. As in point 8, this is a mechanical device, not a machine learning model.

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OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.

The OsteoMed Hand Fusion System implants are intended for single use only.

The OsteoMed Hand Fusion System consists of plates, fusion screws and surgical instruments. Plates and fusion screws are provided in various sizes. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).

Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. These instrüments are made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The OsteoMed Hand Fusion System is a medical device intended for bone fusion and arthrodesis of phalanges and metacarpals. The device's acceptance criteria and subsequent study were based on demonstrating substantial equivalence to predicate devices regarding dimensional and material characteristics, mechanical strength, and pullout strength.

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or human subjects. The evaluation was based on engineering analyses and mechanical testing. Therefore, the concept of sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) as typically applied to clinical studies is not applicable here.

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

This section is not applicable. The ground truth was established through engineering calculations and mechanical testing, not through expert consensus on clinical data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation was based on engineering analysis and mechanical testing, not on clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through engineering analysis and mechanical testing, not on comparing human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

This section is not applicable. The device is a physical implant system, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for evaluating the OsteoMed Hand Fusion System was based on:

• Engineering principles and calculations: For plate strength comparison.
• Mechanical testing standards and results: For screw factor of safety, screw pullout strength, and plate and screw construct performance.
• The comparison was against established performance characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set

This section is not applicable. The evaluation did not involve a "training set" in the context of machine learning or clinical trials. The device's design and material characteristics were based on established engineering principles for medical implants.

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

This section is not applicable for the reasons stated in point 8.

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The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.

Implants and drills are single use only.

The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.

The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.

The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The OsteoMed Low Profile Neuro Fixation System is a medical device used for cranial bone fixation.

Here's an analysis of its acceptance criteria and the supporting study:

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 a sample size for a "test set" in the traditional sense of clinical trials or AI model evaluation. The performance evaluation was primarily based on mechanical testing and finite element analysis (FEA) rather than a test set of patient data.

The data provenance is retrospective, comparing the new device's mechanical characteristics to existing predicate devices. It does not involve prospective data collection from human or animal subjects for performance evaluation in this context.

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

Not applicable. The "ground truth" for this device's performance was established through engineering principles and established mechanical testing standards, not expert human interpretation of medical images or clinical outcomes. The "experts" involved would be mechanical engineers and material scientists who designed the tests and analyzed the results.

4. Adjudication Method for the Test Set

Not applicable. There was no "adjudication method" in the context of clinical or diagnostic testing. The evaluation was based on objective mechanical measurements and computational modeling (FEA).

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. This device is a surgical implant (fixation system) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its evaluation.

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

This question is not directly applicable. The device itself is a physical component. Its "standalone performance" refers to its mechanical integrity and biocompatibility, which were assessed through the described mechanical testing, FEA, and material analysis. There is no "algorithm" in this context.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance was:

• Mechanical properties of predicate devices: The established strength and performance characteristics of legally marketed predicate neuro plates served as the benchmark.
• Engineering specifications and standards: Mechanical testing was conducted according to established engineering principles and likely internally defined specifications, as well as biocompatibility standards (e.g., ASTM F-136, ASTM F-67, ANSI/AAMI ST72:2002).
• Material properties: The known properties of Titanium Alloy and commercially pure Titanium contributed to the "ground truth" regarding material strength and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

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The PrimaLOK™FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive.

It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity.

For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

The PrimaLOK™FF Facet Fixation System is a partially threaded, cannulated, self-tapping 4.5mm screw having an assembled, articulating washer. It is available in lengths from 25 to 45mm to accommodate differing anatomic requirements.

This 510(k) summary (K102438) describes a Class II medical device, the PrimaLOK™ FF Facet Fixation System. This system is a spinal implant intended to stabilize the spine as an aid to fusion. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data rather than clinical studies of diagnostic accuracy.

Here's an analysis of the provided information, framed by your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria (e.g., minimum load for bending, minimum pullout strength) are not detailed in this summary. The assessment is qualitative, stating "substantially equivalent." This is typical for 510(k) submissions where equivalence to existing devices is the primary goal, and detailed criteria may be internal to the sponsor and FDA.

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

This submission is for a physical medical device (spinal implant), not a diagnostic algorithm or AI. Therefore, the "test set" refers to the system components used for mechanical testing.

• Sample Size for Test Set: The document does not specify the exact number of PrimaLOK™FF Facet Fixation Systems or components tested for each mechanical test. This level of detail is typically found in the full test reports, which are not included in the public 510(k) summary.
• Data Provenance: The mechanical tests (static and dynamic cantilever bending, axial pullout) were conducted in a laboratory setting by OsteoMed Spine Inc. (or their contractors). This is prospective testing specifically performed to support this 510(k) submission. Country of origin for the data is implicitly the USA (where the sponsor is located and FDA operates).

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

Not applicable. For mechanical device testing, "ground truth" is established by the standardized test methods themselves (ASTM F2193, ASTM F543) and measurements taken by qualified technicians/engineers. There are no "experts" in the sense of clinical reviewers establishing diagnostic ground truth here.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical performance testing, not a clinical review process requiring adjudication.

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

No. This is a spinal implant and the submission focuses on its mechanical properties and substantial equivalence to existing devices, not on the performance of human readers with or without AI assistance.

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

Yes, in a sense. The "standalone" performance here refers to the mechanical evaluation of the device itself (PrimaLOK™FF Facet Fixation System) without direct human interaction beyond the setup and execution of the tests in a laboratory environment. The tests characterize the device's inherent mechanical properties.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by the engineering standards and methodologies used for mechanical testing. Specifically:

• Standardized Test Methods: ASTM F2193 (modified for cantilever bending) and ASTM F543 (for axial pullout). These standards define how the material properties and device performance under specific loads should be measured and interpreted.
• Predicate Device Performance: The ground truth for demonstrating substantial equivalence is the known mechanical performance of the legally marketed predicate devices. The PrimaLOK™FF system's performance is compared against these benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and previous device designs, but not a dataset in the AI sense.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

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The PrimaLOKTM SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOKTM SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

The PrimaLOKTM SP Interspinous Fusion System is a bilateral locking plate system which attaches to the spine at the spinous processes. It is available in various interspinous heights and widths to accommodate differing anatomic requirements.

The PrimaLOK™sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device for spinal fusion.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data or human evaluation. The performance data is derived from mechanical bench testing. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this summary for clinical evaluation. The "worst case" PrimaLOK™sp Interspinous Fusion System construct was tested, implying representative samples of the device were used for the mechanical tests.

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

Not applicable. The "ground truth" for this device's performance is established by mechanical engineering standards and measurements, not expert human assessment of images or clinical outcomes in the context of the provided information.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for human expert review of clinical data, which is not described here.

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

No. This document describes a premarket notification (510(k)) based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, not a clinical MRMC comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical implant. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to its evaluation.

7. The Type of Ground Truth Used

The ground truth used for assessing this device is based on mechanical engineering standards and measurements. Specifically, the performance was measured against a modified ASTM F1717 protocol, which outlines standardized tests for spinal implant constructs. The "ground truth" is the established mechanical properties required for such devices to be considered safe and effective in their intended use.

8. The Sample Size for the Training Set

No training set is applicable or described. This is a physical device evaluated through mechanical testing, not a machine learning model requiring a training set.

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

Not applicable, as no training set is described.

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The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the device.

The OsteoMed Foot Plating System implants are intended for single use only.

This submission describes the OsteoMed Foot Plating System consisting of various shape and sizes plates featuring compression, locking, elongated or compression elongated holes, and ulated locking, non-locking and cannulated screws, implantable K-wires, washers, and angulated instrumentation. The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. All implants are intended for single use only. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants.

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 implants are made of Titanium (ASTM F-67, ASTM F-136, or ASTM F-1472) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided text does not contain information about acceptance criteria or a study proving that the OsteoMed Foot Plate and Screw Rigid Fixation System meets such criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, materials, design, and operational principles.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details.

The document explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Foot Plating System does not raise any new safety or effectiveness issues." This statement suggests that the clearance was based on demonstrating equivalence to existing, legally marketed devices rather than on a new performance study with specific acceptance criteria as you've outlined.

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OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device.

The OsteoMed Hand Plating System implants are intended for single use only.

The OsteoMed Hand Plating System is a rigid fixation system consisting of plates and screws in various configurations. Plates are provided in a variety of shapes and sizes, and offer surgeons compression and locking hole designs. The Hand Plating System includes angulated locking, nonlocking, lag, and cannulated screws as well as a buttress pin and K-wire implants. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).

The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided 510(k) summary for the OsteoMed Hand Plating System (K090522) does not contain any data from a study demonstrating the device meets specific acceptance criteria.

The submission focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles. It explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Hand Plating System does not raise any new safety or effectiveness issues." This indicates that the regulatory pathway chosen was primarily reliant on comparison to existing, cleared devices, rather than new performance studies with pre-defined acceptance criteria.

Therefore, I cannot provide the requested information for the following sections:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is provided.
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, as no test set requiring ground truth establishment is described.
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: This device is a physical hand plating system, not an AI or imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical hand plating system, not an algorithm. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary that establishes substantial equivalence through comparison to predicate devices, rather than through presenting new performance data from a primary study with acceptance criteria.

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The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint.

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head.

This 510(k) summary for the OsteoMed Metatarsal Resurfacing Implant System with Hydroxylapatite Coating (K081876) indicates that the device was found substantially equivalent to a predicate device (OsteoMed Metatarsal Resurfacing Implant System K073065). The summary does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification, indications for use, and substantial equivalence to a predicate device, rather than detailed performance data or a study report.

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The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.

This looks like a 510(k) summary for a medical device that has achieved substantial equivalence, not a study evaluating whether a device meets specific acceptance criteria through performance.

The provided text, K080694, describes the OsteoMed Modular Locking Fixation System, indicated for fracture fixation in cranio-maxillofacial trauma, mandibular reconstruction, and orthognathic reconstruction. However, it is a document seeking clearance for a medical device by demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with acceptance criteria and reported device performance metrics.

Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because this document is not a performance study in that sense.

Here's a breakdown based on the provided text, Highlighting why certain information is not available from this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This document does not describe a performance study with a test set.
• Data Provenance: Not applicable. This document relies on comparisons to predicate devices and their established safety and effectiveness.

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

• Not applicable. No test set or ground truth establishment by experts is described in this document.

4. Adjudication Method for the Test Set

• Not applicable. No test set adjudication is described.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. This submission uses a substantial equivalence pathway.

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

• Not applicable. This is a physical medical device (plates, screws, instrumentation), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable. No ground truth is established or used in this submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning that the device is shown to be as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of physical, non-AI medical device submission.

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

• Not applicable. (See #8)

Summary Explanation:

The document provided (K080694) is a 510(k) premarket notification. The primary goal of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device (or devices). This means the device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

This clearance pathway typically involves:

• Comparison to Predicate Devices: Identifying existing devices with similar indications for use, materials, and design.
• Performance Testing (Non-Clinical): Often involves bench testing (e.g., mechanical strength, fatigue, biocompatibility) to ensure the device meets specified engineering standards and performs comparably to the predicates. These tests are usually against internal company specifications or recognized standards, not necessarily "acceptance criteria" for a clinical performance study.
• Material Equivalence: Demonstrating that materials used are equivalent to those in predicate devices or have established safe use.

The text explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448), and Lorenz (K063052)." and "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues."

Therefore, this document does not contain the information requested about a clinical study involving acceptance criteria, test sets, expert adjudication, or AI performance metrics because it is a regulatory clearance document based on substantial equivalence, not a clinical trial report.

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The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful MTP joint.

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteoMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head. Primary fixation is intended to be used with bone cement or press fit without bone cement.

The provided text is a 510(k) summary for the OsteoMed Metatarsal Resurfacing Implant System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not found in this type of submission. This 510(k) summary does not describe a clinical study with performance endpoints, ground truth, or expert review for a medical imaging or AI device.

Here's an breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) summary for this device does not present specific performance acceptance criteria or report performance metrics in the way a study for a diagnostic or AI device would. The core of this submission is to demonstrate equivalence based on:

• Intended use
• Materials
• Design
• Operational principle

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

Not applicable. There is no "test set" in the context of a clinical performance study described for this implant.

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

Not applicable. There is no ground truth establishment for a test set described.

4. Adjudication method 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 or diagnostic imaging device.

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

Not applicable. This is not an AI or diagnostic imaging device.

7. The type of ground truth used

Not applicable. No ground truth is described.

8. The sample size for the training set

Not applicable. There is no "training set" for an algorithm described.

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

Not applicable.

Summary of the Acceptance Criteria and Study (as defined by this 510(k) submission):

The "acceptance criteria" for the OsteoMed Metatarsal Resurfacing Implant System, within the context of this 510(k) submission, are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices.

The "Study" that proves the device meets these "acceptance criteria":

The "study" or justification provided is a comparison to several predicate devices. The submission asserts that due to the "similarity in intended use, materials, design and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Metatarsal Resurfacing Implant System does not raise any new safety or effectiveness issues."

Predicate Devices:

• Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859)
• CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370)
• Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052)
• OsteoMed 1st MPJ Hemi Implant System (K060536)
• ReFlexion Great Toe System (K922211)
• BioPro Hemi MPJoint (K041595)

Therefore, the "proof" is the argument for substantial equivalence based on these comparisons, rather than a clinical performance study with statistical endpoints specific to the device's function as an implant.

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