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The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.

The DePuy Mitek RIGIDFIX® CURVE Cross Pin System consists of instruments and Cross Pins designed for use with the RIGIDFIX® CURVE Cross Pin Instrumentation. The Soft Tissue (ST) Cross Pin material is PEEK™ (polyetheretherketone), a radiolucent high strength thermoplastic or PLA (Poly-Lactic Acid). Repair requires two (2) DePuy Mitek RIGIDFIX® CURVE Cross Pins.

The provided documentation describes a 510(k) submission for the DePuy Mitek RIGIDFIX® CURVE Cross Pin System. This system is a medical device designed for femoral fixation of ACL soft tissue grafts.

The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI or diagnostic devices, is not applicable to this type of submission.

Here's a breakdown of the available information:

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)

This information is not provided in the summary. The testing mentioned (In-Vitro Break Strength Testing and Real-Time Break Strength Testing) would involve physical samples of the device and likely would not have a "test set" in the sense of patient data.

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)

This information is not applicable as the submission relies on physical and material testing, not expert-derived ground truth from patient data.

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

This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is a submission for a surgical implant system, not an AI or diagnostic imaging device.

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

This information is not applicable. This is not an AI algorithm.

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

The "ground truth" in this context is the performance and safety profiles of the legally marketed predicate devices, as established through their prior 510(k) clearances and the manufacturer's own design verification activities (e.g., break strength testing). The goal is to show that the new device meets or exceeds these established benchmarks.

8. The sample size for the training set

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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RigidFix Biocryl Cross Pin Kits:
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.
The RigidFix Biocryl Fcmoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).

BioIntrafix Tibial Tapered Sheaths and Screws:
The BioIntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.

Biocryl Interference Screws:
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts gr bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

RigidFix Biocryl Cross Pin Kits:
The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are used for the fixation of bone-tendon-bone grafts to the femur and the tibia in Anterior Cruciate Ligament (ACL) reconstruction. A total of four RigidFix Biocryl 2.7 mm BTB Cross Pins are used to complete the reconstruction: two on the femur and two on the tibia.
The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used to complete the repair.
The proposed RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix biocryl Tibial 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are used to complete the repair.
Each RigidFix Biocryl Cross Pin Kit is provided sterile and is for single patient use only.
Except for the Interlocking Trocar and Sleeve assemblies that are packaged in the RigidFix kits with the RigidFix Biocryl pins, other reusable instrumentation is offered separately to assist in the placement of the RigidFix Biocryl pins. The instrumentation consists of Tibial Guide Frame, Tibial Rods, Long Stepped Trocar, Trocar Trial, Guide Block Head Thumb Screw, Probe, Short Stepped Trocar, Tibial Pin Insertion Rod and Femora/Tibial Rod Thumb Screw. These devices are all stainless steel, non-sterile, reusable devices. In accordance to CFR §888.4540, these are Class I devices and, therefore, are exempt from 510(k) premarketing notification procedures. Validated cleaning and sterilization instructions are provided for those instruments.

BioIntrafix Tibial Tapered Sheaths and Screws:
The DePuy Mitek BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are absorbable implants made from a composite of absorbable Polylactic Acid (PLA) Polymer and Tricalcium Phosphate (TCP). They are used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are supplied sterile ready to use. The tie tensioner is a non-sterile, reusable instrument used to apply and measure tension on the graft.

Biocryl Interference Screws:
The DePuy Mitek Biocryl Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly Lactic Acid.(PLA) polymer and Tricalcium Phosphate (TCP). The Biocryl Interference Screw is packaged one per pouch.

This document describes a 510(k) premarket notification for several medical devices: RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, and Biocryl Interference Screws. The submission aims to establish substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Study Details:

Based on the provided text, there is no specific acceptance criteria table or a study described to demonstrate the device meets acceptance criteria in the traditional sense of a clinical or performance study with defined metrics.

Instead, the submission for these devices relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the primary "acceptance criterion" is that the new devices have the same indications for use and technological characteristics as their predicates, and therefore, do not introduce new questions of safety or effectiveness.

Here's a breakdown based on your requested information, acknowledging the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
   Identical Indications for Use	Met
   Identical Technological Characteristics (design, materials)	Met
   Maintain Safety and Performance	Inferred as met based on predicate device performance, as "additional safety and performance testing on the proposed products are not necessary."

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

   • No test set in a traditional sense was used for this 510(k) submission. The submission is based on a comparison to predicate devices, not new testing of the current devices for safety and performance in clinical or laboratory settings.
   • The document mentions a "36-month stability study reviewed to support a 3-year shelf life claim," but does not provide details on its methodology, sample size, or results. This study is related to shelf-life, not clinical performance or safety.

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

   • Not applicable. No external experts were used to establish ground truth for a test set for this submission, as reported studies were not conducted on the devices themselves.

4. Adjudication Method for the Test Set:

   • Not applicable. No test set requiring adjudication was used.

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

   • No. No MRMC comparative effectiveness study was conducted or reported in this document.

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

   • No. These are physical medical implants, not software algorithms, so a standalone algorithm study is not relevant.

7. Type of Ground Truth Used:

   • For the purpose of this 510(k) submission, the "ground truth" essentially refers to the established safety and effectiveness profiles of the predicate devices, which have already undergone regulatory clearance based on their own testing and real-world performance. There is no new ground truth established for the described devices through new studies.

8. Sample Size for the Training Set:

   • Not applicable. These are physical implants, not AI/ML models, so there is no "training set."

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

   • Not applicable. See point 8.

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The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended for femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.

The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).

The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autografi or allograft ACL soft tissue grafts (semitendinosus and gracillis).

The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are used for the fixation of bone-tendon-bone grafts to the femur and the tibia in Anterior Cruciate Ligament (ACL) reconstruction. A total of four RigidFix Biocryl 2.7 mm BTB Cross Pins are used to complete the reconstruction: two on the femur and two on the tibia.

The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used to complete the repair.

The proposed RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix biocryl Tibial 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are used to complete the repair.

Each RigidFix Biocryl Cross Pin Kit is provided sterile and is for single patient use only.

Except for the Interlocking Trocar and Sleeve assemblies that are packaged in the RigidFix kits with the RigidFix Biocryl pins, other reusable instrumentation is offered separately to assist in the placement of the RigidFix Biocryl pins. The instrumentation consists of Tibial Guide Frame, Tibial Rods, Long Stepped Trocar, Trocar Trial. Guide Block Head Thumb Screw, Probe, Short Stepped Trocar, Tibial Pin Insertion Rod and Femora/Tibial Rod Thumb Screw. These devices are all stainless steel, non-sterile, reusable devices.

This 510(k) summary for the RigidFix Biocryl Cross Pin Kit describes a medical device, specifically absorbable implants for ACL reconstruction. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.

Here's why and what information is present:

What is present in the document:

• Device Description: The document describes the RigidFix Biocryl Cross Pins as absorbable implants made from "Biocryl" (15% ß-TCP/85%PLA). It specifies their use for femoral and tibial fixation of bone-tendon-bone or soft tissue grafts in ACL reconstruction.
• Indications for Use: Clearly states the intended use for different versions of the cross pins (BTB and ST) for ACL reconstruction with autograft or allograft.
• Predicate Devices: Lists several predicate devices (e.g., RigidFix Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, Biocryl Interference Screws) to which the new device is claimed substantially equivalent.
• Safety and Performance Statement: Mentions "certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification." This is the closest mention of performance data, but it's a general statement, not a detailed report.

What is missing from the document (and therefore cannot be provided in the table/answers):
The document is a 510(k) summary, which generally provides an overview for substantial equivalence, not detailed study reports. It does not contain the specific technical performance data, acceptance criteria, or study design details that would be found in a full study report or the body of the 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions below because the necessary information is not provided in the given text.

Unable to Complete - Information Not Provided in the Document

The provided 510(k) summary for the RigidFix Biocryl Cross Pin Kit does not include the detailed information regarding acceptance criteria, specific device performance metrics, study design (sample sizes, data provenance, ground truth establishment, expert adjudication), or comparative effectiveness study results. The summary only generally states that "results of validation testing (performance testing) for the device modification" were provided in support of the 510(k).

To fully answer your request, a detailed performance testing report would be required.

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This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.

This document describes the Sterling® IF Screw Eyelet, a soft tissue graft fixation device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on performance criteria or specific studies.

Therefore, I cannot provide the requested information in the format specified. The information about the Sterling® IF Screw Eyelet is limited to:

• Proprietary Name: Sterling® IF Screw Eyelet
• Common Name: soft tissue graft fixation device
• Product Code: HWC. Orthopedics Panel
• Regulation Number: 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fastener.
• Description: Manufactured from bovine bone, processed with BioCleanse® Tissue Sterilization Process. 25mm long by 8mm wide with an oval eyelet. To be used with Sterling Interference Screw HT.
• Intended Use: Graft fixation (e.g., ligament and tendon) in cruciate ligament reconstruction surgeries.
• Substantial Equivalence: To LinX HT (design/function) and Sterling Interference Screw ST and Sterling Interference Screw HT (materials/function).
• Material Source: Closed herd in the U.S.A.
• Viral Inactivation Study: Worst-case representation of BioCleanse® process showed a reduction of a panel of viruses to below detectable limits.

To address each point of your request directly based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample size used for the test set and the data provenance: Not provided in the text. (The mention of a viral inactivation study doesn't specify a "test set" in the context of device performance, nor does it provide sample size or provenance for general device acceptance.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
4. Adjudication method: Not provided in the text.
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 and not provided in the text. (This is not an AI-assisted device for diagnostic imaging or similar applications.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided in the text.
7. The type of ground truth used: Not provided in the text. (The viral inactivation study implies laboratory assay results for "ground truth" on viral reduction, but this is not about overall device performance acceptance criteria.)
8. The sample size for the training set: Not provided in the text.
9. How the ground truth for the training set was established: Not provided in the text.

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The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw. The device will be offered sterile and is single use.

The provided text is a 510(k) summary for a medical device (A.M. Surgical CPF Distal Radial External Cross Pin Fixation System) and a clearance letter from the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given input.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use: For what medical conditions and anatomical location the device is used.
• Predicate Device Comparison: How it compares to previously cleared devices to establish substantial equivalence.
• Regulatory Classification: Its class and product code by the FDA.
• FDA Clearance Letter: Official communication from the FDA confirming clearance.

There is no mention of any performance study, clinical trial data, or specific acceptance criteria for performance other than the device being "substantially equivalent to the predicate and is safe and effective for its intended use" based on design and intended use comparison.

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The Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

The cannulated Cross Pins are 40-60mm long by 6-9mm diameter with a conical tip 10mm long.

This document describes a 510(k) premarket notification for the Biosteon Cross Pin, a medical device. The information provided heavily focuses on the device's substantial equivalence to predicate devices, particularly in materials, manufacturing, function, and indications for use.

Based on the provided text, there is no acceptance criteria or study information related to device performance in the context of AI/ML or diagnostic accuracy. The submission is mechanical and material focused for a physical implantable device.

Therefore, I cannot populate the requested table and answer the questions. The provided text does not contain information about:

• Acceptance criteria (beyond functional equivalence to a predicate device)
• Reported device performance (in terms of sensitivity, specificity, etc.)
• Sample sizes for test sets or data provenance (as it's not a data-driven device)
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth (as it's not a diagnostic device)
• Sample size for training set
• How ground truth for the training set was established

The document details a traditional medical device submission for a physical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The "acceptance criteria" for this device would have been related to mechanical strength, biocompatibility, and sterilization, which were likely demonstrated through engineering tests and material characterization, and comparison to predicate devices, rather than clinical study performance metrics or expert consensus on diagnostic accuracy.

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The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

The Stryker Interference Screw Cross Pin System consists of an implant and associated instruments for installation of the implant . The implant consists of two components: an interference screw with cross pin hole, and a cross pin for the interference screw. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin.

This document is a 510(k) premarket notification for a medical device (Stryker Interference Screw Cross Pin System) and describes its substantial equivalence to a predicate device, rather than providing a study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The core of this document is a regulatory submission for substantial equivalence based on the device's similarity to a previously approved device, not a detailed performance study with quantifiable acceptance criteria.

The available information only states that:

• Device Name: Stryker Interference Screw Cross Pin System
• Intended Use: Surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of various ACL allografts and autografts.
• Predicate Device: Stryker Wedge Interference Screw (#K972233).
• Conclusion: The subject device was shown to have substantially equivalent performance when compared to the predicate device in terms of intended use, safety, and efficacy.

Without a detailed performance study, it's impossible to fill out the table or answer the specific questions about acceptance criteria and how a study demonstrated their achievement.

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The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.

The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).

The provided document is a 510(k) summary for the "RigidFix™ 2.7mm BTB Cross Pin Kit," a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with acceptance criteria in the way a new drug or high-risk medical device might.

Therefore, many of the requested elements (like acceptance criteria for a study, sample sizes for test/training sets of data, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI/algorithm performance studies, which were not conducted or required for this device.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Proving Device Meets Criteria

This submission is a 510(k) Pre-market Notification for a Class II medical device (Appliance for reconstruction of bone to soft tissue). The core purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise new questions of safety and effectiveness.

For this device, the "acceptance criteria" are predominantly related to demonstrating functional equivalence and safety through bench testing and biocompatibility testing, rather than clinical performance metrics in a study involving human subjects. The acceptance criteria for these tests would typically be defined as meeting certain material properties, mechanical strength thresholds, and biological compatibility standards that are comparable to or better than the predicate device and established industry standards.

The "study" that proves the device meets these criteria is the functional and integrity bench testing and biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly list numerical acceptance criteria or detailed results of specific tests (e.g., "tensile strength must be > X MPa, and device achieved Y MPa"), a precise table cannot be constructed. However, based on the text, the general acceptance criteria and performance can be inferred:

Regarding the other requested information:

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

• Not Applicable. This submission details design verification and validation through bench testing and biocompatibility, not clinical data sets involving human subjects. Therefore, there's no "test set" of patient data, data provenance, or retrospective/prospective nature to describe in that context. The "sample size" for bench tests would refer to the number of devices tested, which is not specified in this summary.

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

• Not Applicable. As no clinical "test set" data from patients was used, there was no need for experts to establish ground truth in this manner. Evaluation was based on engineering and biological testing standards.

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

• Not Applicable. No human-based adjudication of patient data was required for this type of 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 is not an AI/algorithm-based device and no MRMC studies were conducted or relevant.

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

• Not Applicable. This is a hardware implantable device, not an algorithm.

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

• For the functional and integrity testing, the "ground truth" would be established engineering specifications, mechanical principles, and validated test methods.
• For biocompatibility, the "ground truth" is established biological safety standards as outlined in documents like ISO 10993 (referenced as "International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" and FDA Memorandum #G95-1).

8. The sample size for the training set:

• Not Applicable. No machine learning model or "training set" was involved.

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

• Not Applicable. As above, no training set was used.

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The Stryker Cross-Pinned Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

The Stryker Cross-Pinned Interference Screw consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw and a cross pin. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin. Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 *. The devices are biocompatible per ISO-10993 and G95-1. The material of construction is Ti-6AI-4 V ELI per ASTM F136.

The provided text describes a 510(k) premarket notification for the Stryker Cross-Pinned Interference Screw System, submitted to the FDA. This document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with acceptance criteria in the manner typically seen for new diagnostic algorithms or AI devices.

Therefore, the following information is extracted or inferred from the text, recognizing that it is not a study design for evaluating algorithm performance, but rather a submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The text mentions "cadaver testing," but does not explicitly state the sample size (e.g., number of cadavers, number of screws tested).
• Data Provenance: The cadaver testing is presumably laboratory-based testing, not clinical data from a specific country. The study is prospective in the sense that the testing was conducted specifically to evaluate this new device's performance against the predicate.

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

• This information is not applicable to this submission. The "ground truth" for a physical device like an interference screw is its mechanical performance (yield load, ultimate load), not an expert interpretation of data.

4. Adjudication method for the test set

• This information is not applicable. Mechanical testing results (yield load, ultimate load) are quantitative measurements, not subject to expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable. This is a physical medical device, not an AI or diagnostic tool that requires human reader studies.

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

• This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance evaluation in this context is the mechanical load data (yield load and ultimate load) obtained from cadaveric testing. This is objective, quantitative physical measurement data.

8. The sample size for the training set

• This information is not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• This information is not applicable. This is a physical medical device, not an AI model.

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To hold a Semi Tendonosus ST (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstrution surgery.

Femoral fixation of autograft or allograft ACL soft tissue grafts

The Cross Pin is 1.654 " long by 0.132" dia. with a conical tip by 0.180" long. The Cross Pin is molded from Purac PLA.

The provided text describes a submission for a medical device (Mitek 3.3mm ST Cross Pin) seeking 510(k) clearance. The document focuses on comparing the new device to a predicate device (Acufex EndoButton) to establish substantial equivalence based on non-clinical tests.

Here's an analysis of the acceptance criteria and study information, based only 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

The text mentions "Bench fixation strength tests, bending and shear" and "In-Vitro evaluation tests." However, it does not specify the sample size used for these tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these were bench and in-vitro tests, not human trials.

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

This information is not applicable and not provided in the document. The "tests" performed were non-clinical bench and in-vitro evaluations of mechanical properties, not diagnostic or clinical assessments requiring expert ground truth establishment in the traditional sense for medical imaging or clinical outcome studies.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies in observations or diagnoses. Since these were bench tests, an adjudication method for a test set is not relevant.

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. The document explicitly states: "No clinical tests were done." This device is a mechanical implant, and the study was focused on its mechanical properties compared to a predicate device, not on diagnostic accuracy or AI assistance for human readers.

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

This information is not applicable and not provided. The device is a physical medical implant (a cross pin), not an algorithm or AI system. Therefore, standalone performance in the context of an algorithm is irrelevant.

7. The type of ground truth used

For the bench fixation strength, bending, and shear tests, the "ground truth" was established by direct measurement of physical properties (strength, stiffness) of the devices under controlled experimental conditions. For the in-vitro evaluation tests, the "ground truth" was the directly measured ultimate strength of the hamstring grafts under various cross pin orientations. This is based on objective, quantifiable physical properties rather than expert consensus or pathology in a biological sense.

8. The sample size for the training set

This information is not applicable and not provided. The assessment was a direct comparison of physical properties of two medical devices. There was no "training set" in the context of machine learning or predictive modeling.

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

This information is not applicable and not provided for the same reason as point 8. There was no training set.

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