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OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.
Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears
OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures.

OSI Q System Arthroscopes are rigid, fixed arthroscopes with a wide-angle view and a rod lens imaging system with a fiber optic illumination system to provide visualization of various anatomic structures during diagnostic and operative arthroscopic procedures. OSI Q System Arthroscopes have surgical stainless steel shafts and lens housing for durability and are available with various angles of view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surgical site and surgeon preference. OSI Q System Arthroscopes have a working length of 175.5 mm to 212.5 mm. diameters ranging from 3.1 mm to 5 mm. an angle of view (direction of view) of either 30° or 70°, and a field of view of either 90° or 100°. Visualization sheaths are provided in three designs, with diameters of either 5 mm or 6.1 mm, an angle of view of 0°, 30°, or 70°, and working lengths ranging from 151 mm to 185.5 mm.
The arthroscope main body tube, insertion tube, and optic tube are all made from 304 stainless steel. The other patient contacting parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate OSI Arthroscopes (K091398). The visualization sheaths are made from 316 stainless steel.
Arthroscopes are provided non-sterile and are reusable. Visualization sheaths are provided sterile for single use only.

Acceptance Criteria and Study for OSI Q System Arthroscopes (K133018)

Based on the provided 510(k) summary, the OSI Q System Arthroscopes were determined to be substantially equivalent to previously marketed predicate devices (K091398 and K992782) and therefore did not require new clinical or non-clinical studies to establish acceptance criteria or prove performance. The submission relies on the established performance of the predicate device K091398 to demonstrate the performance of the subject device.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new studies were conducted, the "acceptance criteria" for the subject device are implicitly met by its technological characteristics being "the same as" or "similar to" the predicate devices. The performance reported for the subject device is directly tied to the predicate.

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

• Sample Size: Not applicable. No new test set was used. The submission relies on existing data and regulatory clearances of predicate devices.
• Data Provenance: Not applicable for a new test set. The data provenance for the predicate device K091398 (Orthopedic Sciences, Inc., Arthroscope) and K992782 (NuVasive, Inc., Spinal Arthroscope) would be tied to their original clearances, which are not detailed in this summary.

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

• Not applicable. No new test set requiring expert ground truth establishment was used for this submission.

4. Adjudication method for the test set

• Not applicable. No new test set required adjudication for this submission.

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 an arthroscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not applicable. This device is an arthroscope, not a standalone algorithm.

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

• Not applicable. The substantial equivalence determination is based on the comparison of the device's technological characteristics to legally marketed predicate devices, not on direct clinical ground truth generation for the subject device itself.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable. As this is not an AI/machine learning device, no training set or its associated ground truth establishment methods are relevant.

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The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.

Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears

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The provided text is a US FDA 510(k) clearance letter for an Arthroscope (K091398). This document primarily describes the regulatory clearance of a medical device and its intended use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the specific details outlined, as this information is not present in the provided text. The document is about regulatory approval based on "substantial equivalence" to a predicate device, which often means demonstrating that the new device has the same intended use and technological characteristics as a legally marketed device, or that any differences do not raise new questions of safety or effectiveness. This type of submission generally does not require the comprehensive performance study data you're asking for.

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The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The provided text is a 510(k) summary for a medical device (Titanium Hip Tool™ Locking Plate), indicating its administrative information, intended use, and substantial equivalence to a predicate device. It is a regulatory document and does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a scientific study or clinical report.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for test sets
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study details (effect size)
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is focused on demonstrating regulatory compliance based on substantial equivalence rather than presenting detailed performance study data.

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The TS-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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This document is a 510(k) summary for the TS-Bone Hip Tool™. It describes an orthopedic device intended to stabilize a bone graft, not an AI/ML powered device. As such, the requested information regarding acceptance criteria and studies for device performance as it relates to AI/ML devices, such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this submission.

The 510(k) process for this type of device typically focuses on substantial equivalence to a predicate device based on manufacturing materials, design, intended use, and mechanical testing, rather than algorithmic performance.

Therefore, I cannot provide the requested table and details because the provided document does not contain information about an AI/ML powered device or a study comparing its performance to acceptance criteria in the manner described by your prompt.

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The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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The provided text describes a 510(k) premarket notification for a medical device, the "Titanium-TSYTM Shoulder Plate Implant." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with strict acceptance criteria and performance studies like those often associated with novel high-risk devices or software.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, and MRMC studies is not explicitly available in the provided document. The 510(k) summary focuses on administrative information, device description, predicate device identification, and intended use to establish substantial equivalence.

Here's an explanation based on the provided text, addressing why certain information is absent and what can be inferred:

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

• Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, mechanical strength values) are reported in this summary. The substantial equivalence argument implies similar performance to the predicate.

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

• Test Set Sample Size & Data Provenance: Not applicable and not mentioned. 510(k) submissions typically do not involve a "test set" in the sense of a clinical trial for performance evaluation. Substantial equivalence is often demonstrated through bench testing (for mechanical properties, biocompatibility), materials comparison, and comparison of design features to the predicate. No clinical data (prospective or retrospective) is presented here.

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):

• Experts & Qualifications for Ground Truth: Not applicable and not mentioned. Since there isn't a "test set" with clinical outcomes requiring expert interpretation for ground truth, such information is not part of this 510(k) summary.

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

• Adjudication Method: Not applicable and not mentioned for the same reasons as #3.

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:

• MRMC Study: Not applicable. This device is a bone plate implant, a mechanical orthopedic device, not an AI-powered diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable. As mentioned, this is a mechanical implant, not an algorithm or AI.

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

• Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is effectively the safety and effectiveness of the predicate device (TSYTM Shoulder Plate Implant, K040850). The new device aims to be substantially equivalent to that established "truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

• Ground Truth for Training Set: Not applicable for the same reasons as #8.

Summary based on the document:

The provided document is a 510(k) summary for the "Titanium-TSYTM Shoulder Plate Implant." The basis of its acceptance and clearance by the FDA is substantial equivalence to a previously cleared predicate device, the TSYTM Shoulder Plate Implant (K040850), cleared on June 24, 2004.

The document 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 marketed in interstate commerce prior to May 28, 1976..."

This means the "study" that proves the device meets "acceptance criteria" is the comparison to the predicate device focusing on:

• Intended Use: The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture. This is the same intended use as the predicate.
• Technological Characteristics: While not detailed in this summary, a 510(k) submission would typically include comparisons of materials (titanium vs. whatever the predicate was made of, ensuring biocompatibility), design features, and possibly bench testing to demonstrate similar mechanical performance and safety profiles. The name itself, "Titanium-TSYTM," suggests a material change from the predicate "TSYTM Shoulder Plate Implant."

Without the full 510(k) submission, specific details of the comparison (e.g., mechanical test results, detailed material specifications) are not available. However, the FDA's clearance indicates that the submitted information was sufficient to demonstrate substantial equivalence and meet the regulatory requirements for Class II devices.

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The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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This document is a 510(k) summary for a medical device called the "S-Bone Hip Tool™", a bone plate. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about performance studies with acceptance criteria or ground truth establishment typically associated with AI/ML devices. Therefore, I cannot provide the requested information.

The document does not contain the following information:

• Acceptance criteria and reported device performance: This document is a regulatory submission for a bone fixation device, not an AI/ML algorithm. It doesn't present performance metrics like sensitivity, specificity, or F1-score with acceptance criteria, which are common for AI/ML device evaluations.
• Sample size and data provenance for a test set: This information is not relevant to a 510(k) submission for a bone plate, where evaluation typically involves mechanical testing or clinical use data for the device itself rather than a test set for an algorithm.
• Number and qualifications of experts for ground truth: Not applicable for this type of device submission.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: This device is a physical bone plate, not an algorithm.
• Type of ground truth used: Not applicable as it's not an AI/ML device.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

Since the provided document is for a physical medical device (bone plate) and not an AI/ML powered device, the questions related to AI/ML evaluation metrics and study design are not applicable. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, which is typically done through comparison of indications for use, technological characteristics, and performance data from mechanical testing or clinical experience without the need for detailed ground truth establishment methods for an algorithm.

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The Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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This document is a 510(k) summary for the Titanium-Hip ToolTM. It indicates that the device is substantially equivalent to a previously cleared predicate device (Hip Tool™ Implant, K022139) and describes its intended use. However, it does not contain any information about acceptance criteria, performance studies, or clinical data that would typically be used to prove a device meets such criteria.

Therefore, I cannot provide the requested table and information based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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This 510(k) summary (K051181) describes a modification to an existing device, the Custom-Hip Tool™. As such, the submission primarily focuses on demonstrating substantial equivalence to the predicate device (Hip Tool™ Implant, K022139) rather than presenting a new clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not explicitly detailed in this document.

However, based on the provided text, we can infer some aspects and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria: The document does not specify quantitative performance metrics (e.g., tensile strength, fatigue life, stability under certain loads, specific healing rates, or accuracy of placement) for the Custom-Hip Tool™ or the predicate device that were used to establish substantial equivalence.
• Specific comparative performance data: No explicit data comparing the performance of the Custom-Hip Tool™ to the Hip Tool™ Implant (K022139) is presented in this summary. The substantial equivalence determination is a regulatory finding, not a disclosure of a full performance study report.

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

This 510(k) summary does not describe a de novo study with a test set. The submission is for a device modification, relying on the substantial equivalence to a predicate device. Therefore, information on a "test set" in the context of an original clinical or performance study is not provided.

If there were any in vitro or in vivo bench testing performed to support the modification, the details (sample size, data provenance) are not included in this summary.

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

This information is not applicable or provided. Since no clinical or performance study with a test set (requiring ground truth) is described in this 510(k) summary, there is no mention of experts or their qualifications for establishing ground truth. The FDA's review for substantial equivalence is based on the information provided by the manufacturer, which typically includes device specifications, design comparisons, and potentially bench testing, rather than a new clinical study.

4. Adjudication Method for the Test Set

This information is not applicable or provided for the same reasons as point 3.

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

This information is not applicable or provided. The Custom-Hip Tool™ is a medical implant intended to stabilize bone grafts. It is not an imaging device or AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable or provided. The Custom-Hip Tool™ is an implantable device, not a software algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

This information is not applicable or provided. As there is no de novo study with a test set generating new "ground truth," this concept is not discussed in the summary. The substantial equivalence determination relies on the existing knowledge and regulatory history of the predicate device.

8. Sample Size for the Training Set

This information is not applicable or provided. The Custom-Hip Tool™ is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI model development.

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

This information is not applicable or provided for the same reasons as point 8.

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The OutologousTM Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).

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This looks like a 510(k) summary for a medical device called the "Outologous Spinal Fixation System." This type of document is for proving substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI algorithm might.

Therefore, the requested information about acceptance criteria, study design, ground truth, and expert adjudication as typically applied to performance claims of AI/ML devices is not present in this document. The document primarily focuses on regulatory classification, intended use, and the FDA's marketing clearance.

Here's a breakdown of why the requested information cannot be extracted from the provided text according to the specific prompt questions:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria in the sense of a clinical trial for efficacy or diagnostic accuracy. It's about demonstrating substantial equivalence structurally and functionally to existing devices.

2. Sample size used for the test set and the data provenance: Not applicable. There is no specific "test set" for performance evaluation in this context. The demonstration of substantial equivalence relies on design, material, and mechanical testing, but not on clinical performance data in the way an AI algorithm would.

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 clinical performance is not established or reported in this type of submission.

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: Not applicable. This is a spinal fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable. There is no "training set" for an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory clearance for a physical medical device (spinal fixation system) based on substantial equivalence, and therefore the types of studies and performance metrics typically associated with AI/ML-based diagnostic devices (which your questions are geared towards) are not relevant or reported here.

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The TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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The provided document is a 510(k) summary for a medical device called the "TSY™ Shoulder Plate Implant," which is a bone fixation appliance. It details the administrative information, predicate device, and intended use. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary serves to establish substantial equivalence to a legally marketed predicate device, not to present performance study results against specific acceptance criteria in the manner you've described. The content provided is typical of a premarket notification where the focus is on device description, intended use, and comparison to a predicate, rather than detailed performance data from clinical or non-clinical studies.

Therefore, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication, or ground truth, as none of this information is present in the provided text.

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