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The subject devices are single use components, intended for cemented use only. The indications for the use of these tibial trays, in keeping with those of other legally marketed Howmedica Osteonics tibial trays, are as follows:

Indications:

• . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• . Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized Components:

• . Ligmentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.

Howmedica Osteonics® Series 7000 AD Tibial Trays are intended for cemented fixation on the prepared proximal tibia and are designed to achieve total reconstructive replacement of the knee joint when used in conjunction with the Howmedica Osteonics® Total Knee Femoral, Patellar and Tibial Insert Components. The metallic tibial tray is manufactured from ASTM F75-92 CoCr alloy. The "pocketless" design of the fixation surface employs a roughened, arc-deposited ASTM F67-95 CP Titanium coating. The keeled stems of the Howmedica Osteonics® Series 7000 AD Tibial Tray employ a satin finish and are not coated with arc-deposited CP Titanium. Screw hole plugs, fabricated from low density polyethylene (LDPE), are located in the tibial tray screw holes.

The provided text is a 510(k) Premarket Notification Summary for a medical device, the Howmedica Osteonics® Series 7000 AD Tibial Tray. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy or performance through a typical clinical study with acceptance criteria and statistical analysis.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size for test sets, expert involvement in ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training.

Instead, the "study" demonstrating the device meets acceptance criteria is actually a comparison to a predicate device. The fundamental acceptance criterion for a 510(k) submission is "substantial equivalence" to a legally marketed predicate device.

Here's how the provided information relates to your request, noting the absence of the specific details you're looking for:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in the typical sense of a performance study (e.g., sensitivity, specificity, accuracy thresholds) and reported statistical performance values. Instead, the acceptance criterion for regulatory approval is "Substantial Equivalence" to predicate devices.

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

Not applicable/Not provided. This type of information is typically found in clinical trial reports or performance studies, which are not part of this 510(k) summary. The "test set" here would conceptually be the device itself being compared to standards and predicates. There is no mention of a patient-based test set.

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

Not applicable/Not provided. Ground truth establishment by experts is relevant for diagnostic devices or those requiring subjective clinical assessment. This device is a pre-formed orthopedic implant.

4. Adjudication method for the test set

Not applicable/Not provided. No formal adjudication method is mentioned as there isn't a "test set" of observations being interpreted.

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 is a hardware orthopedic implant, not an AI-assisted diagnostic device. MRMC studies are not applicable.

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

Not applicable. This is a hardware orthopedic implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's design, materials, and intended use are compared against these known, approved products. In essence, the "truth" is that the predicate devices are safe and effective, and the new device is "substantially equivalent" to them. A "Coating Characterization Summary" is mentioned, which would involve material property testing and thus likely rely on scientific/engineering standards and measurements, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of device design approval for a hardware implant. The design process would involve engineering principles, materials science, and testing, but not machine learning training.

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

Not applicable/Not provided. As there's no training set, there's no ground truth established for one. The "truth" in this context is based on engineering specifications and comparison to existing, approved devices.

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The Osteonics® HA-AD Coated Devices are single-use, acetabular of femoral hip implant devices intended for cementless applications. The following indications for use are consistent with previous submissions for these acetabular and femoral components intended for cementless application.

Indications for Osteonics® HA-AD Acetabular Components

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for Osteonics® HA-AD Femoral Components
For use as a Bipolar Hip Replacement :

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The devices which are the subject of this 510(k) are commercially-available Osteonics hip acetabular and hip femoral components featuring Osteonics' HA-AD coating.

The provided text describes a 510(k) submission for Osteonics HA-Coated Devices, focusing on claims related to the performance of their HA-AD coating. It is noteworthy that this submission is from 1999, and the type of detailed performance criteria, ground truth establishment, and multi-reader studies applied to modern AI/ML devices were not standard practice for medical device submissions at that time.

Therefore, many of the requested categories for AI/ML device studies will not be present in this document.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way a modern AI/ML device submission would, with quantifiable thresholds for performance metrics. Instead, it refers to "additional performance claims" demonstrated by referenced literature.

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

• Sample Size: Not specified in the provided text for the individual studies. The studies are described as using "animal models" (canine hip implant, canine implantable chamber model, canine hip prosthesis).
• Data Provenance: Animal models (canine). All studies appear to be prospective experimental studies. The original location/country of the animal studies is not stated within this 510(k) summary.

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

This information is not provided. Given the nature of these animal studies (histological and biomechanical analyses), the "ground truth" would likely be established by trained researchers and pathologists examining tissue samples and conducting measurements, but explicit details on the number or qualifications of experts are absent.

4. Adjudication Method for the Test Set

This information is not provided.

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 MRMC study was done, as this submission pre-dates the common use of AI in medical devices and the associated study designs.

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

This is not applicable, as the device is a physical implant, not an algorithm. Therefore, "standalone" performance testing in the AI/ML sense was not conducted. The "performance data" refers to the biological response to the coating.

7. The Type of Ground Truth Used

The ground truth used was histological analysis (e.g., bone apposition, linear bone contact, bone penetration) and biomechanical analysis performed on animal tissue samples. This is analogous to pathology or biological outcomes data in a clinical context.

8. The Sample Size for the Training Set

No "training set" in the context of AI/ML algorithms is mentioned or relevant here, as this device is a physical implant, not a software algorithm. The studies referenced are experimental studies on the biological performance of the coating.

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

Not applicable, as there is no "training set" for an AI/ML algorithm. The ground truth for the performance studies themselves (as described in point 7) was established through scientific experimental methods, including histological and biomechanical assessments, as detailed in the referenced research papers.

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The following are specific indications for the Osteonics® Spinal System:

As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients. the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136-96 Titanium alloy (Ti6A1-4V ELI). The Osteonics® Spinal System Sacral Offset Connector Assembly may be used in any application where supplemental sacral screw placement is desired by the surgeon. This assembly allows a sacral connector with supplemental sacral screw to the joined to the spinal rod in the sacral offset blocker secures the sacral screw to the connector assembly. The Clamping Screw is used with the Sacral Offset Connector to provide a stable lock on the longitudinal spinal rod.

This document describes a 510(k) premarket notification for a medical device, specifically the Osteonics® Spinal System - Sacral Offset Connector Assembly. The submission focuses on demonstrating substantial equivalence to predicate devices through material, design, and intended use comparison.

However, the provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The document primarily covers:

• Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification name).
• Predicate Device Identification: Listing similar commercially available spinal systems.
• Device Description: Materials, intended use (sacral screw placement, connecting to spinal rod, clamping screw for stable lock).
• Intended Use/Indications For Use: Detailed list of spinal conditions for which the system is indicated, both as a non-pedicle screw system and as a pedicle screw fixation system.
• Statement of Technological Comparison: Asserts substantial equivalence based on materials, intended uses, and basic design concepts, and mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

Missing Information:

The document explicitly states that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components" under the "Statement of Technological Comparison." This indicates that some form of testing was performed. However, the details required to directly answer your request are not present in the provided text.

Specifically, the following information is not provided:

1. A table of acceptance criteria and the reported device performance: While testing is mentioned, no specific criteria (e.g., maximum load, cycles to failure) or numerical results are given.
2. Sample size used for the test set and the data provenance: No information on the number of devices tested or if the data was retrospective/prospective, or country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a mechanical device, so expert review of "ground truth" in clinical image interpretation or diagnosis would not be applicable in this context.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a mechanical spinal fixation device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points under specified conditions, defined by engineering standards. The document only states "Fatigue and static testing," but no specific standards or detailed methodology.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not an AI alogorithm that uses training data.
9. How the ground truth for the training set was established: Not applicable.

To answer your request thoroughly, additional documentation regarding the specific fatigue and static testing performed on the Osteonics® Spinal System Sacral Offset Connector Assembly would be required. This would typically be found in engineering reports or test summaries that are part of the full 510(k) submission, but are not included in this excerpt.

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The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

• degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• decompression of the spinal cord following total or partial cervical vertebrectomy .
• trauma (fractures) .
• tumors
• pseudarthrosis .
• · failed previous fusions

The Osteonics® ACCP System is an anterior cervical plate that incorporates a one-piece monoblock design, or a two- or three-piece modular design, depending on plate length, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. Optional bone graft screws are also available for insertion through the center screw hole of the modular plate designs. The Osteonics® ACCP is placed logitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. The Osteonics® ACCP is available in lengths ranging from 24mm to 100mm. A slotted locking screw hole on the proximal and distal end of each preassembled plate allows the surgeon to adjust the plate in order to apply compression to a specific area along the cervical spine, thus optimizing the compressive forces which aid in achieving a successful fusion. Locking screws are firmly tightened after the surgeon has adjusted the plate to the desired level of compression. All Osteonics® ACCP System components are manufactured from ASTM F-136-96 titanium alloy.

The provided text indicates that the Osteonics® ACCP System (Anterior Cervical Compression Plating System) was cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, specifically anterior cervical plates offered by Synthes. This means the primary "acceptance criteria" and the "study that proves the device meets the acceptance criteria" largely revolve around this concept of substantial equivalence rather than a detailed performance study with quantitative metrics for the Osteonics® ACCP System itself.

Here's a breakdown of the requested information based on the provided text, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to a predicate device.

Note: For 510(k) submissions, the acceptance criteria are not typically expressed as numerical performance targets (e.g., "fusion rate > 90%") for the new device, but rather as demonstrating that the device is as safe and effective as a legally marketed predicate device (which presumably met such standards in its own approval process).

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

The provided document does not describe a clinical performance study with a distinct "test set" and sample size for the Osteonics® ACCP System. The submission relies on a comparison to a predicate device to establish substantial equivalence. Therefore, there is no information on:

• Sample size for a test set
• Country of origin of data
• Retrospective or prospective nature of data

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

Since no clinical "test set" or performance study for the Osteonics® ACCP System is described, there is no information on:

• Number of experts used to establish ground truth
• Qualifications of those experts

4. Adjudication Method for the Test Set

As no clinical "test set" or performance study is described, there is no information on an adjudication method.

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 or described in this submission. This type of study is more common for diagnostic imaging AI devices, whereas this submission is for a medical implant (anterior cervical plate).

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

Not applicable. The Osteonics® ACCP System is a physical medical implant, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" essentially comes from the established safety and effectiveness of the predicate device (Synthes anterior cervical plates) and clinical experience with similar devices. The regulatory pathway relies on demonstrating that the new device is sufficiently similar to the predicate that it can be assumed to operate with the same level of safety and effectiveness, leveraging the existing "ground truth" of the predicate. No specific pathology, outcomes data, or expert consensus was directly established for a new clinical trial concerning the Osteonics® ACCP System within this submission.

8. The Sample Size for the Training Set

The provided document does not describe a training set in the context of an algorithm or AI. It describes a physical medical device.

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

Not applicable, as there is no training set mentioned for this physical device.

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The Osteonics +10 UniPolar Adaptor Sleeve is a single-use device and may be used with all appropriately selected, legally marketed Osteonics C-Taper Femoral Stems and with any size Osteonics legally marketed +0 mm Unipolar Endo Heads (Single-Piece Unipolar Design).

For Use as a Hemi-Hip Replacement:

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

Osteonics +10 UniPolar Adaptor Sleeve is composed of cobalt chromium alloy and is designed to function with any size Osteonics +0 Unipolar Endo Head (Single-Piece Unipolar Design) and any Osteonics C-Taper Femoral Stem. The Osteonics +10 UniPolar Adaptor Sleeve is designed with both a male and a female C-taper. The female end receives the femoral stem and the male end engages the Endo Head.

The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:

• A basic taper design.
• A smooth exterior finish.
• Constructed of material that has a long history of orthopedic use.

This document is a 510(k) summary for a medical device (Osteonics® +10 UniPolar Adaptor Sleeve) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing a study that proves the device meets those criteria in the way a clinical performance study would for a diagnostic or AI-driven device.

Therefore, the requested information elements (acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available within this type of regulatory submission.

Here's why and what information is provided:

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

   • Not Applicable. This document is not a performance study report for a diagnostic or AI device. It's a regulatory submission for a mechanical implant. Performance is assessed through mechanical testing and comparison to predicate devices, not clinical metrics like sensitivity or specificity.
   • The "performance" described relates to the design and material characteristics being consistent with existing, legally marketed devices.

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

   • Not Applicable. There is no "test set" in the context of clinical data for this type of device. The evaluation is based on mechanical testing and material compatibility. The document refers to "pre-clinical data incorporated by reference to prior submissions," which would involve mechanical testing on the device itself, not human subjects or biological samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. Ground truth, in the sense of expert consensus on diagnostic labels, is not relevant for this device. The "ground truth" for a mechanical implant is its physical and mechanical properties matching design specifications and established safety profiles.

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

   • Not Applicable. No clinical or diagnostic adjudication methods are relevant here.

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 mechanical implant, not an AI-driven diagnostic tool.

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

   • Not Applicable. This is a mechanical implant, not an algorithm.

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

   • Not Applicable in the diagnostic sense. The "ground truth" for this device's safety and effectiveness relies on:
     • Material compatibility: Cobalt chromium alloy has a "long history of orthopedic use."
     • Design consistency: Basic taper design, smooth exterior finish, and dimensional specifications designed to accommodate other legally marketed components.
     • Comparison to predicate devices: The "substantial equivalence" framework relies on the new device sharing the same intended use, materials, and similar design features to devices already on the market. The "ground truth" is that these predicate devices are safe and effective.

8. The sample size for the training set:

   • Not Applicable. No training set exists as this is not an AI/ML device.

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

   • Not Applicable. No training set exists.

Summary of what is described (substitute for the requested table):

This 510(k) summary establishes the device's substantial equivalence through comparison to legally marketed predicate devices, focusing on:

Conclusion:

This 510(k) submission successfully argues for substantial equivalence to existing devices on the market, implying that because the predicate devices are considered safe and effective, and the new device shares fundamental characteristics, it is also safe and effective. It explicitly states that "None of these design differences raises any new questions of safety or effectiveness." The "study" proving this device meets (implicit) acceptance criteria is the overall 510(k) submission itself, which relies on comparative analysis and references to pre-clinical data.

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The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:

For Use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

For Use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

The provided document is a 510(k) summary for a medical device modification, specifically for the Osteonics® Primary Secur-Fit™ Plus Hip Stems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness claims. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it would apply to a novel AI/software medical device is not directly applicable here.

However, I can interpret the request in the context of this 510(k) submission, focusing on how the manufacturer demonstrated equivalence and what evidence was presented.

Here's an analysis based on the provided text, addressing the points you raised, with explanations for why some are not applicable to this type of submission:

Acceptance Criteria and Study for Osteonics® Primary Secur-Fit™ Plus Hip Stems (Modified)

The core "acceptance criteria" for this 510(k) submission are that the modified device remains substantially equivalent in terms of safety and effectiveness to the predicate device, despite the modifications. The study performed aims to demonstrate this equivalence, particularly regarding mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document. For mechanical testing of implantable devices like hip stems, "sample size" typically refers to the number of individual stems tested for each configuration (e.g., each size, with/without tri-slot). This exact number is not provided.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. It's implicitly (and standardly) generated by the manufacturer (Osteonics Corporation, based in Allendale, NJ, USA). The testing would be prospective in nature, as it involves newly manufactured devices being subjected to controlled mechanical loads.

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

This concept is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" are typically relevant for diagnostic or AI-driven devices where human experts establish the true condition (e.g., presence of disease in an image). For mechanical testing of a hip stem, the "ground truth" is established by the physical testing itself, measuring properties like fatigue strength against established engineering standards (e.g., ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth. Mechanical testing involves repeatable measurements against objective standards, not subjective expert interpretation.

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

• No, an MRMC study was NOT done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. This submission is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

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

• Not applicable in the context of typical AI/algorithm standalone studies. This device is a passive mechanical implant. The "standalone" performance here refers to the device's inherent mechanical properties (fatigue strength) as measured in a lab setting, without human interaction beyond the setup and execution of the tests. This is what the "Mechanical testing has been performed" statement refers to.

7. The Type of Ground Truth Used

• Engineering/Mechanical Standards and Benchmarking against Predicate: The "ground truth" for this submission would be adherence to relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants (e.g., for fatigue testing of metallic hip prostheses) and, crucially, demonstrating that the modified design performs equivalently to the previously cleared predicate device in those mechanical tests. It's based on quantitative physical measurements against established criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (hip stem), not for an AI model that requires a "training set."

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

Summary in the Context of a 510(k):

The manufacturer demonstrated substantial equivalence by:

• Clearly defining the modifications (smaller sizes, removal of distal tri-slot).
• Stating that all other aspects remained unchanged (material, overall design principles).
• Asserting that mechanical testing was performed to prove equivalent fatigue strength between the modified design(s) and the predicate device.
• Confirming the intended use remains the same.

The FDA reviewed this information and concurred that the device is substantially equivalent, but placed specific labeling limitations related to "biological attachment" or "enhanced fixation" claims, indicating that equivalence was shown only for a "conventional press-fit hip prosthesis (i.e., mechanical interlock, only)."

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The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis
• Vertebral fracture or dislocation
• Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the existing Screw Blocker has been modified to include a proximal circular "lip". Two bars on the proximal side of the containment ring expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component.

The locking mechanism and function of the Combination Screw Ring/Blocker is identical to that currently employed by the Long Arm Containment Ring and the Screw Blocker. The Combination Screw Ring Blocker is placed over the screw arms. The blocker is then tightened, which expands the proximal portion of the screw creating a friction-fit lock between the proximal screw and the containment ring portion of the Combination Screw Ring/Blocker. The screw arms are then broken off.

The provided document is a 510(k) Premarket Notification for the Osteonics® Combination Screw Ring/Blocker. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain explicit "acceptance criteria" for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy thresholds) or a "study" that directly proves the device meets such criteria based on a clinical outcome.

Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in terms of intended use, material, and design, and confirming that the device functions identically to the predicate device. The "study" in this context is the comparison and analysis of the proposed device against the predicate devices.

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

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 applicable. This submission is based on a comparison to predicate devices, not on a clinical test set. No human or animal samples were used for testing in the provided summary.
• Data Provenance: Not applicable.

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. There was no "test set" requiring expert-established ground truth in this submission. The demonstration of substantial equivalence relies on engineering and design comparisons and functional identity to predicate devices.

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

• Not applicable, as there was no test set or expert adjudication process for performance in this 510(k) 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 a mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

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

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior marketing authorization. The new device demonstrates "substantial equivalence" to this established ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no training set.

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

• Not applicable, as there is no training set.

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The following are specific indications for the Osteonics® Spinal System:

For non-pedicular fixation of the T4-S2 spine:

• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) .
• . Vertebral fracture or dislocation
• . Spinal stenosis
• Spondylolisthesis ●
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by patient history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

For pedicular use:

• Additionally, when used as a pedicle screw system, the system is intended for patients: (a) . having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The cylindrical bone screws will be available in standard and extra-long versions in lengths and diameters identical to the predicate top loading tapered screws.

This document is a 510(k) Premarket Notification for the Osteonics® Spinal System Cylindrical Bone Screws. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving performance against acceptance criteria for a novel device. Therefore, a direct answer to your request in the format provided is not fully applicable as the document does not contain a study with acceptance criteria and device performance in the way you've outlined for a new device's validation.

However, I can extract the relevant information from the document to address aspects of your request within the context of a 510(k) submission for substantial equivalence.

Here's an analysis based on the provided text, outlining why some requested information is not present in this type of document and what can be inferred:

Key Takeaway: The provided document is a 510(k) submission, whose primary goal is to demonstrate "substantial equivalence" of a modified device (cylindrical bone screws) to an existing, legally marketed predicate device (tapered bone screws within the same Osteonics® Spinal System), not to establish novel performance against clinical acceptance criteria through a new study.

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in this format: A 510(k) submission for substantial equivalence typically does not present new acceptance criteria and reported device performance in the way a clinical trial or performance study for a novel device would. The core "acceptance criteria" here are that the modified device demonstrates substantial equivalence to the predicate device in terms of intended use, materials, design, and safety/effectiveness.
• Inferred Performance: The document states: "The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws." This is the core "performance" claim for a 510(k) – that the new device performs equivalently to the predicate. The "study" here would be the comparative analysis outlined in the submission.

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

• Not Applicable (Clinical Study): This document does not describe a clinical "test set" in the sense of a patient cohort for a performance study.
• Inferred "Test": The "test" in this context refers to the comparison of the cylindrical bone screws with the tapered predicate screws. This comparison is based on design parameters, material specifications, and intended uses. The "sample size" would effectively be "one" (the modified cylindrical bone screw design) compared against "one" (the predicate tapered bone screw design).
• Data Provenance: Not applicable for a clinical study. The data provenance would relate to the design specifications, material testing (if new), and intended use statements.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: There is no mention of experts establishing a "ground truth" for a clinical test set because a clinical performance study (as you might see for a diagnostic AI device) was not conducted or reported here.
• Inferred Experts: The "experts" involved are likely the engineering and regulatory teams at Osteonics® who designed the device and prepared the submission, and later, the FDA reviewers who assessed the submission for substantial equivalence. Their qualifications are inherent in their roles, but not explicitly stated as "experts for ground truth."

4. Adjudication Method for the Test Set

• Not Applicable: No clinical test set or adjudication method is described. The "adjudication" in this regulatory context is the FDA's review and decision on substantial equivalence.

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

• Not Conducted/Applicable: This is not a study type relevant to the submission of a medical implant (bone screws) for substantial equivalence. MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. There is no AI component here.

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

• Not Conducted/Applicable: This concept is not relevant to bone screws. There is no algorithm or AI component in this device.

7. Type of Ground Truth Used

• Not Applicable (Clinical): There isn't a "ground truth" derived from patient data, pathology, or outcomes in the traditional sense of a clinical performance study.
• Inferred "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness of the predicate device (the tapered bone screws within the Osteonics® Spinal System) and the regulatory framework that dictates how substantial equivalence is demonstrated. The ground truth relies on the assertion that the design changes (cylindrical vs. tapered) do not alter the fundamental function, safety, or effectiveness when compared to the predicate, as evidenced by engineering principles, material science, and the lack of new risks.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device or a device requiring a clinical training phase as part of its development.

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

• Not Applicable: As there is no training set, this question is not relevant.

Summary of Information from the Text Regarding Substantial Equivalence:

The "study" in this context is the comparison presented in the 510(k) to demonstrate substantial equivalence.

• Acceptance Criteria for Substantial Equivalence:
  • Intended Uses: Must be identical to the predicate device.
  • Material: Must be identical or equivalent (same medical-grade titanium alloy, ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI)).
  • Design: Changes (cylindrical vs. tapered) must not introduce new questions of safety or effectiveness and the fundamental function must remain unchanged.
• Reported Device "Performance" (Comparison to Predicate):
  • Intended Uses: "The intended uses of the subject bone screws are identical to those of the predicate bone screws."
  • Material: "The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI)." (Implied identical to predicate).
  • Design: "The design of the modified cylindrical bone screw differs from the predicate bone screw in that the modified bone screw distal diameter is the same as the proximal diameter. The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws."

This 510(k) submission successfully argued substantial equivalence based on these points, leading to FDA clearance (K984302).

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The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System consists of single-use devices. Each Osteonics® Secur-Fit™-AD Generation II Acetabular Component consists of two pieces: an Osteonics® Secur-Fit™-AD Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.

The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells are characterized by the following features:

• A basic dual radius design.
• The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
• A variety of screw hole patterns, including dome hole and peripheral screw holes.
• A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
• Circumferential normalizations.
• A wide range of sizes.
• Osteonics' AD coating.
• Compatibility with the Generation II Cup Insert.

The Osteonics® Generation II Cup Inserts are characterized by the following features:

• A wireless locking mechanism which utilizes a continuous ridge which locks into a groove on the interior of the mating shell.
• A hemispherical geometry which is designed to maximize liner conformity to mating shell.
• Increased indexability through mating of barbs on shell with scalloped areas on insert.

This is a 510(k) premarket notification for a medical device (Osteonics® Secur-Fit™-AD Generation II Acetabular Component System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable. The document discusses mechanical testing for demonstrating substantial equivalence to predicate devices, but no performance metrics for AI/ML algorithms are presented.

Here's a breakdown of why an AI/ML-focused response is not possible:

• Device Type: The device is an acetabular component system, which is a physical implant used in hip replacement surgery. It is explicit "single-use devices".
• Submission Date: The submission date is October 5, 1998, long before the widespread use and regulatory pathways for AI/ML in medical devices were established.
• Performance Data Section: The "Performance Data" section states, "The performance characteristics of the "AD" coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices." This clearly refers to physical and mechanical properties, not algorithmic performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, expert involvement, or ground truth for an AI/ML device, as this document pertains to a traditional medical implant.

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The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

• Static and compression locking
• Transverse and short oblique fractures
• Pseudarthrosis
• Correction osteotomies

The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.

The following changes have been made to the modified Tibial Nail.

• The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
• The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
• In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.

The provided 510(k) K984353 is for a special premarket notification for a modified Osteo 9mm IC Tibial Nail and does not contain a clinical study with acceptance criteria and device performance as typically expected for software-as-a-medical-device (SaMD) or AI-based devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on design and material modifications and mechanical testing, which is common for implantable orthopedic devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria and device performance in the way one would for a diagnostic or AI device (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied by demonstrating that the modified device maintains its mechanical integrity and functionality despite changes, thus remaining substantially equivalent to the predicate device. The "performance" is implicitly demonstrated through the modifications described, which suggest improved characteristics while maintaining the core function.

• Acceptance Criteria (Implied):

  • Maintain overall mechanical integrity and strength for long bone fracture fixation.
  • Continue to provide for alignment and stabilization of long bone fractures.
  • Resist bending and provide increased torsional stability.
  • Be compatible with associated Class I manual surgical instruments.
  • Maintain the same indications for use as the predicate device.
  • Reduce irritation of the patella tendon (new improvement).
  • Wall thickness increase, cannulation diameter reduction, proximal length increase, and taper angle are within acceptable engineering parameters for the intended function.

• Reported Device Performance (Implicit through modifications):

  • Increased wall thickness (by 0.2mm): This generally implies greater strength and resistance to deformation.
  • Reduction in distal cannulation diameter (from 6.4mm to 6.0mm): A consequence of increased wall thickness, still allowing for guide wire usage.
  • Increased length of ø11mm proximal portion (from 33mm to 60mm) and 2° taper: These changes likely improve fit, stability, or surgical technique.
  • Small 10° chamfer (5.7mm in length) on proximal anterior end: Specifically designed to "reduce irritation of the patella tendon," indicating an improvement in patient comfort/safety.
  • The modifications are described to "provide greater resistance to bending and increased torsional stability" (though the pre-modification nail also claimed this, the increased wall thickness would support this for the modified nail).

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

• Not applicable for this type of submission. This submission relies on engineering design changes and mechanical performance evaluations, not clinical data from a "test set" in the context of diagnostic accuracy. The testing would involve physical samples of the device.
• Data Provenance: Not specified as it's a device modification, relying on in-house engineering and potentially biomechanical testing.

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

• Not applicable. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through engineering specifications and testing. It doesn't involve clinical expert consensus on an interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication process as it's not a diagnostic study.

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

• No. This is not a diagnostic device or an AI-assisted interpretation tool. It's an orthopedic implant.

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

• No. This is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering specifications and biomechanical testing (implied). The "ground truth" for this device's performance relies on its physical and mechanical properties as designed and confirmed through standard engineering tests, ensuring it meets the requirements for load-bearing and fracture fixation.

8. The Sample Size for the Training Set:

• Not applicable. No "training set" in the context of an algorithm. Design iterations and materials research would be more analogous to "training," but not in the AI sense.

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

• Not applicable. See point 8.

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