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The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm.

The provided document is a 510(k) summary for the Asfora Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the manner of AI/software devices. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.

Here's an attempt to extract and interpret the information based on the context of a medical device submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

For mechanical implants like the Asfora Anterior Cervical Plate System, "acceptance criteria" and "reported device performance" are typically defined by compliance with recognized ASTM standards for spinal implants. The document states:

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

• Sample Size for Test Set: Not applicable in the context of this type of mechanical device evaluation. The "test set" would refer to the physical samples of the device and its components used for mechanical testing. The document does not specify the number of individual plates, screws, or constructs tested.
• Data Provenance: The mechanical testing data would be generated from laboratory tests conducted on the physical device prototypes. The country of origin for the testing itself is not specified but would typically occur at the manufacturer's facility or a contract testing lab. This is a prospective evaluation in the sense that the device prototypes were specifically manufactured and tested for this submission.

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

• Number of Experts & Qualifications: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is not established by human experts in the same way as, for example, image interpretation for an AI algorithm. The "ground truth" would be the engineering specifications and performance standards defined by the ASTM F 1717 standard itself. The engineers and technicians conducting the tests are qualified in mechanical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are typically objective measurements (e.g., load at failure, displacement). There is no "adjudication" in the sense of reconciling differing expert opinions. The test results are compared directly against the performance requirements of the relevant ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• MRMC Study: No. This is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating AI algorithms that assist human readers (e.g., radiologists, pathologists).

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

• Standalone Performance: No. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For the mechanical testing, the "ground truth" is the performance specifications and requirements defined by the ASTM F 1717 standard for spinal intervertebral body fixation orthoses. The device is expected to meet or exceed these established engineering benchmarks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device. The design and manufacturing processes are based on established engineering principles and materials science, not machine learning.

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

• Ground Truth for Training Set: Not applicable. As there's no training set, there's no ground truth needing to be established for it. The design of such a device relies on accepted biomechanical principles, material properties, and clinical experience, rather than data-driven "ground truth" in the AI sense.

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The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

The SAMBA screw is a cannulated metallic bone screw designed to stabilize the sacroiliac (SI) joint. The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. The SAMBA screw is 9 mm in diameter and offered in 25-50 mm lengths with multiple longitudinal slots on its shaft. Each slot set consists of four (4) holes oriented 90 degrees apart around the circumference of the screw at specified axial location. It will be provided as sterile, single units packaged in a sealed tray and pouch. The screw is a single use device and is not intended to be resterilized.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria in the way a diagnostic AI product might. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable or not provided in this type of document.

The document primarily describes mechanical testing for the device's functional and performance requirements.

Here's a breakdown of the information that can be extracted or noted as not applicable:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the mechanical testing, but refers to "representative samples." This document does not describe a clinical "test set" in the context of an AI/diagnostic device.
• Data Provenance: The mechanical testing is laboratory-based, not patient-data based.

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: This is a hardware device (bone screw) undergoing mechanical testing, not a diagnostic AI product requiring expert-established ground truth from images or clinical data.

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

• Not Applicable: As above, this is mechanical testing, not a diagnostic study with a test set requiring adjudication.

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 a hardware implant, 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 a hardware implant.

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

• Not Applicable (in the clinical/diagnostic sense): For this device, the "ground truth" for compliance would be the established engineering and materials standards (ASTM F2193-02, ASTM F543-07, ASTM F-136) that the device must meet through mechanical testing.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of a hardware device undergoing mechanical testing.

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

• Not Applicable: There is no "training set" for this type of device submission.

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The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.

The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.

This document is a 510(k) Premarket Notification for a Hand Drill (Catalog # 11-9901-7) manufactured by Medical Designs, LLC. The primary goal of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a predicate device that is already legally marketed in the U.S. This type of submission generally does not include a formal study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) or De Novo submission, especially for a Class II manual surgical instrument.

Therefore, the requested information elements related to specific performance acceptance criteria, clinical study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), and training set information are not applicable or present in this 510(k) summary.

Instead, the demonstration of safety and effectiveness relies on comparison to a predicate device and similarities in design, materials, and intended use.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission does not include a formal clinical study with pre-defined acceptance criteria and reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The criteria for acceptance in a 510(k) are based on demonstrating substantial equivalence to a predicate device, primarily through comparison of intended use, technological characteristics, and safety/effectiveness profiles.

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

Not applicable. No formal test set or clinical data is presented for performance evaluation in this 510(k) submission.

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

Not applicable. Ground truth for a test set is not established as no performance study is detailed.

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

Not applicable. No test set requiring adjudication is described.

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 device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

Not applicable. Ground truth for a performance study is not relevant for this 510(k) submission.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a learning algorithm that requires a training set.

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

Not applicable. Ground truth for a training set is not relevant for this 510(k) submission.

Summary of the 510(k) Approach for this Device:

The 510(k) submission for the Medical Designs Hand Drill establishes substantial equivalence to the Integra NeuroSciences Camino Hand Drill - Model 030 (K862160) by demonstrating:

• Identical Intended Use: Both devices are intended for use in Neurosurgical procedures. The Medical Designs Hand Drill also specifies use with their Subdural Evacuating Port System Kit (S.E.P.S.), which is a further specific application within neurosurgery.
• Similar Technological Characteristics: The submission states that the Medical Designs hand drill is made of "the same materials and components as the predicate device" (ABS plastic housing, glass filled nylon handle, ABS plastic handle knob, lubricated aluminum gears, ¼" spring-loaded, chrome-plated steel, 3-jaw chuck assembly). The device is also a single-use disposable and sterilized using gamma radiation.
• Biocompatibility: The materials are stated to be identical to the predicate device, and neither device comes into direct contact with the body or bodily fluids when used as intended. This addresses biocompatibility concerns by similarity.
• No new issues of safety or effectiveness: By using identical materials and having the same intended use, the submission argues that the device does not raise any new safety or effectiveness concerns compared to the predicate.

The FDA's review and clearance (NOV 12 2002) indicate their agreement that substantial equivalence was demonstrated, allowing the device to be marketed. This regulatory pathway does not typically require an extensive performance study with quantitative acceptance criteria as would be needed for novel or higher-risk devices.

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