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The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:

• Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
• . Traumatic arthritis.

The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.

Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only

The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.

The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.

Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.

I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.

Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)

The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).

1. Table of Acceptance Criteria and Reported Device Performance

A. Bench Testing (Non-Clinical Mechanical Performance)

B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)

1. Change in Constant score is ≥ 17;
2. No revision surgery;
3. No radiographic evidence of system disassembly or fracture;
4. No system-related serious adverse event. | Composite Clinical Success (CCS):

• Intent to Treat (ITT): 82.7%
• Per Protocol (PP): 87.9%

Component Success Rates:

• Free of Revision: 98.1% (154/157)
• Constant Score improved 17+ points (among those with evaluable scores): 84.6% (121/143)
• Free of disassembly or fracture: 100.0% (157/157)
• Free of device related SAE: 96.8% (152/157) | Composite Clinical Success (CCS):
• Intent to Treat (ITT): 66.8%
• Per Protocol (PP): 63.1%

Component Success Rates:

• Free of Revision: 94.7% (160/169)
• Constant Score improved 17+ points (among those with evaluable scores): 73.1% (49/67)
• Free of disassembly or fracture: 100.0% (169/169)
• Free of device related SAE: 94.7% (160/169) |

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

• Sample Size (Test Set):
  • Pyrocarbon (Investigational) Group: 157 subjects enrolled.
  • Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
• Data Provenance:
  • Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
  • Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).

4. Adjudication Method for the Test Set

This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:

• The primary endpoint was a composite outcome, objectively defined.
• "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
• Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.

6. If a Standalone (Algorithm Only) Performance Study was done

No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

For the clinical study:

• Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
• Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."

For the bench testing:

• Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
• Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.

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

This question is not applicable for the reasons stated above.

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The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.

mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Intearating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The system is designed for the following medical specialties:

• Orthopedics .
• . Surgery and Traumatology
• Rheumatology t
• . Pediatric Orthopedics

MediCAD is designed for pre-operative planning for the following applications:

• Hip Manual Planning .
• Hip Automatic Planning t
• Hip Biometry .
• . Hip - Coxometrv
• . Hip - Wear Measurement
• . Hip - FAI
• Knee Prosthetic Planning .
• Biometry Planning takes into account patient motion and metrics .
• Coxometry tracking of known measurement values in pediatrics to . determine surqical intervention
• . Osteotomy - determines optimum osteotomy locations
• . Osteotomy bv Dror Palev
• Osteotomy (DualSide)
• Spine
• Foot
• Upper Extremities
• Biological Age Determination by Hand
• Trauma

Concentrating within the specialty of joint replacement, mediCAD 3.0 will provide an orthopedic surgeon with the ability to produce pre-surgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, mediCAD provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper presurgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

The device has been designed and manufactured to conform to the following standards: Digital Imaging and Communications in Medicine (DICOM) V3.0, ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to Computer software. ISO 14971:2007 Application of Risk Management of Medical Devices and ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

I'm sorry, but the provided text does not contain the specific information required to complete the table and answer the questions related to the acceptance criteria and the study proving the device meets those criteria.

Here's why:

• No explicit acceptance criteria are listed. The document states that "Validation testing through professional medics in clinical environment confirm that the device meets performance, measurement and usability requirements," but it does not specify what those "performance, measurement, and usability requirements" are, nor does it provide a table of acceptance criteria and reported device performance.
• Details of the validation study are missing. While it mentions "Validation testing through professional medics in clinical environment," it does not provide details such as:
  • Sample size used for the test set or its data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
  • Whether a standalone (algorithm only) performance study was done.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to predicate devices and lists the intended uses and technical specifications. It does not delve into the detailed performance validation study as requested.

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The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:

This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.

2. Sample Sizes and Data Provenance

• Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
• Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
• Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
  • Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
• Clinical Testing:
  • Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
  • Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."

3. Number of Experts and Qualifications for Ground Truth for Test Set

This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.

• For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.

4. Adjudication Method for the Test Set

Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.

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

No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.

6. Standalone Performance Study

This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).

7. Type of Ground Truth Used

• Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
• Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
• Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
• Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.

8. Sample Size for the Training Set

This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.

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The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to the PACS system. These images can be aimed at images helping the surgeon plan the actual prosthetic implant. These plans can also be shown to surgical placement of the implant. They will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consists of guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

The provided text does not contain any information about acceptance criteria, study details, or performance metrics for the Agfa IMPAX® OT3000 Orthopedic Workstation.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study. It states that "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate device."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies.

Summary of what is missing from the provided text:

• Acceptance Criteria and Reported Performance: No specific performance metrics or thresholds are mentioned.
• Study Details: No study is described that evaluates the device's accuracy or effectiveness. The 510(k) submission relies on substantial equivalence to a predicate device (Siemens' EndoMap).
• Sample Sizes: No information on test sets or training sets.
• Data Provenance: No details on where any data (if used for testing) originated.
• Experts and Ground Truth: No mention of experts, how ground truth was established, or adjudication methods.
• MRMC Study: No information about a comparative effectiveness study with human readers.
• Standalone Performance: No standalone performance study is described.
• Type of Ground Truth: Not applicable since no performance study is detailed.
• Training Set Sample Size and Ground Truth: Not applicable since no training or performance study is detailed.

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The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (c.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment.

As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present.

The application consists of the following components:

• Hip Prosthetic Planning .
• Knee Prosthetic Planning ●
• Biometry Planning takes into account patient motion and metrics .
• Coxometry tracking of known measurement values in pediatrics to determine surgical . intervention
• Osteotomy determines optimum osteotomy locations .
• Impax Diagnostic Workstation ●

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

Here's an analysis of the provided text regarding the Agfa IMPAX® OT3000 Orthopedic Workstation, focusing on the acceptance criteria and study information:

Based on the provided 510(k) summary, there is no detailed information regarding specific acceptance criteria or an explicit study proving the device meets them. The document primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not explicitly stated in the document. The submission is based on substantial equivalence, implying that the device's performance aligns with that of the predicate device (Siemens' EndoMap).
   • Reported Device Performance: Not explicitly enumerated in performance metrics. The document states that the "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices."

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

   • This information is not provided in the document. No specific test set or study data is mentioned.

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

   • This information is not provided in the document. No information on ground truth establishment for a test set is present.

4. Adjudication Method for the Test Set:

   • This information is not provided in the document. No test set or related adjudication method is mentioned.

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

   • No MRMC study is mentioned or referenced. The document does not discuss human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

   • No standalone performance study for the algorithm is described. The focus is on the software's functionality and its substantial equivalence to a predicate device, not on specific performance metrics of the algorithm itself.

7. Type of Ground Truth Used:

   • This information is not provided. As no specific study or test set is detailed, the type of ground truth used is not mentioned.

8. Sample Size for the Training Set:

   • This information is not provided. There is no mention of a training set or its size.

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

   • This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also absent.

Summary of what the document does provide:

• Intended Use: The workstation is designed for orthopedic surgical planning, accessing images, educating patients, and monitoring progress. It allows for placing digital templates of orthopedic implants on patient images to aid in surgical planning.
• Predicate Device: The Agfa IMPAX® OT3000 is deemed substantially equivalent to the Siemens' EndoMap (K014113).
• Technological Identity: The document explicitly states, "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices." This is the primary "proof" of its suitability for market, based on the 510(k) pathway for substantial equivalence.

Conclusion:

The provided 510(k) summary is typical for a substantial equivalence submission, where detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment are often not included if the device is found to be sufficiently similar to an already cleared predicate device. The "proof" the device meets acceptance criteria essentially relies on its "identical" technological and functional characteristics to a legally marketed predicate. It does not contain the granular study details typically found for novel devices or those undergoing more rigorous performance testing.

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Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semi-automatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.

The VIDAR Bone Track System is comprised of three modules: The Pre-Operative Module, the Tracking Module and the Post-Operative Module

In the Pre-Operative Module, the patient's digital x-ray is then loaded into the software, either from the hospital network, via a disk or from a digital scanner. The x-ray image is located in the system using standard digital measuring tools. The physician chooses which orthopedic device to template. The user then utilizes the software tools to overlay pre-loaded digital templates onto the x-ray image to allow for proper prosthetic selection. Once the physician has selected all of the appropriate prosthetic components, the software generates a pick list to allow for easy ordering of parts. This list can be printed out.

The VIDAR Bone Track System allows for tracking of orthopedic devices used during patient surgery. Using a PDA and a bar code reader, the devices' bar codes are scanned. Device manufacturer. device part number, lot number, and serial number are captured.

The VIDAR Bone Track System's Post-Operative Module allows the physician to track migration or other changes to the implant in the bones' structures for a specific patient over time using industry-accepted algorithms. The physician can use measurements include stem dislocation, wear circle cup and wear elliptic cup. Bone Track is not a diagnostic tool. It is to be used by the physician as an assistance tool.

The Vidar Bone Track System Software, a device designed for pre-operative digital implant templating and post-operative tracking of orthopedic implants, underwent "bench testing" to ensure it met its intended performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document broadly states "Bench testing was performed." It does not specify a distinct "test set" in terms of patient data or images. The testing appears to be focused on the software's functional capabilities rather than its performance on a dataset of patient cases. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a patient dataset is not provided.

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

As no specific test set based on patient cases or outcomes is described, there is no mention of experts establishing ground truth or their qualifications. The "bench testing" likely involved internal software validation and verification by the company's development team or independent testers against functional specifications.

4. Adjudication Method for the Test Set:

Given the nature of "bench testing" without a specific patient-based test set, an adjudication method for reconciling expert opinions is not applicable and therefore not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. The document focuses on the device's functional performance and its substantial equivalence to a predicate device, not on its comparative effectiveness with human readers or the effect size of AI-assisted improvements.

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

The description implies that the software's functionality was tested in a standalone manner as part of the "bench testing." However, the device is explicitly intended to be an "assistance tool" for physicians, meaning human-in-the-loop interaction is inherent to its intended use. The performance data provided does not differentiate between standalone algorithmic performance and human-in-the-loop performance.

7. The Type of Ground Truth Used:

For the "bench testing," the "ground truth" would have been the functional specifications and design requirements of the software. Each feature, from digital templating to pick list generation and tracking capabilities, would have been tested against its intended design and expected output. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The document does not provide information about a training set. The Vidar Bone Track System Software appears to be a rule-based or template-driven system rather than a machine learning model that would require a distinct training set for algorithm development.

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

As no training set is mentioned or implied for this device, information on how its ground truth was established is not provided.

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The EndoMap package is an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. The software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the EndoMap software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

The EndoMap System is a x-ray imaging software option, which allows the planning of orthopedic surgeries on several Siemens workstations such as the LEONARDO, the syngo® Multimodality Workstation and the Magic View 300. The Leonardo Workstation was described in the 510(k) premarket notification, K992073, which received FDA clearance on Sept. 09, 1999. The syngo® Multimodality Workstation K010938 received FDA clearance on June 26, 2001. The EndoMap program enables exact adaptation of the prosthesis to the existing anatomic conditions based on digital images of the pelvis and the leg skeletal structure. This is accomplished using various help functions such as determination of the rotation center and the rotation of the pelvis, medialization, leg length correction, reflection via the symmetric axis of the body, biomechanical evaluation of the hip geometry and coxometry (analysis of the hip values). The planning data can be saved to the database of the LEONARDO or other workstations and output to a laser or paper printer.

The provided text is a 510(k) summary for the EndoMap system, an X-ray imaging system software option for planning orthopedic surgeries. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details on performance metrics or study methodologies.

The document primarily focuses on:

• Identification of the device: EndoMap, its classification, and intended use.
• Substantial equivalence: Comparing EndoMap to predicate devices (BrainLabs' VectorVision Hip and Knee) based on functional specifications.
• Device description: General features and functionalities.
• Regulatory approval: The FDA clearance letter stating substantial equivalence.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies based on the provided text. The document explicitly states that "Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in Attachment 5," and that "the functional specifications and the substantial equivalence comparison matrix proves that the EndoMap Software is substantially equivalent." This suggests that the detailed equivalence information, which would typically contain performance data if such a study were deemed necessary for equivalence, is located in an attachment not provided here.

Based on the provided text, the following information is missing:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on substantial equivalence to predicate devices rather than independent performance metrics against predefined criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is described as an aid for surgeons in planning, but no studies on reader performance or improvement are detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned or detailed. The nature of the device as a planning aid implies human interaction.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

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The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.

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I am sorry, but the provided text from the FDA 510(k) letters for OrthoPlan does not contain any information about acceptance criteria, study details, or performance metrics of the device.

The letters primarily address a substantial equivalence determination and an administrative correction. They state that the device is a "Template for clinical use" (product code HWT) and describe its indications for use as:

"The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries."

Since the document does not contain the requested information about acceptance criteria and study data, I cannot fulfill your request to describe them.

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The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.

This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal.

The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.

This premarket notification describes a software device (ORTHODOC Model 500 Preoperative Planning Software) and does not provide an acceptance criterion or a study proving that the device meets an acceptance criterion. The document explicitly states:

"There has been no pre-clinical or clinical performance data Performance data: generated upon which to make a decision of substantial equivalence."

Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

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