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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The subject device is an extension line of 510(K) cleared device Conformity stem, cementless (K183312, K242249), which introduces four new variations: (1) Conformity stem, #0; (2) Conformity stem, collared, #0; (3) Conformity stem, coxa vara, 125° STD, collared, #0; and (4) Conformity stem, short neck, collared #0. The indications, design rationales, materials, manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312, K242249).
Conformity Stem can collocate with “United” metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, #0
  Conformity stem, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity Stem, #1, #11 (K183312)The only differences in the items are the offset specifications and stem length.
• Conformity stem, collared, #0
• Conformity stem, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, collared, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity stem, collared, #1, #11 (K183312).The only differences in the items are the offset specifications and stem length.
• Conformity Stem, coxa vara, 125° STD, collared, #0
• Conformity Stem, coxa vara, 125° STD, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, coxa vara 125° STD, collared, #1-7 (K242249). The material, coating thickness, neck angle (125°), and neck length (32.5mm) design are identical to 510 (k) cleared device Conformity stem, 125° STD, collared, #1, #7 (K242249). The only differences in the items are the offset specifications and stem length.
• Conformity Stem, short neck, collared #0
• Conformity Stem, short neck, collared #0 is an extension in terms of sizes to 510 (k) cleared device Conformity Stem, short neck, collared, #1-7 (K183312 and K242249). The material, coating thickness, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, collared, #1, #7 (K183312 and K242249). The only differences in the items are the offset specifications and stem length.

The provided text is a 510(k) summary for a medical device (hip stem extension line). It details the device's identity, intended use, and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices based on:

1. Identical Indications for Use: The new device has the same indications as the predicate devices.
2. Similar Technological Characteristics: The material, principle of operation, regulation number, product code, risk class, intended users, fixation method, surface coating, locking mechanism, and sterilization method are the same as the predicate device.
3. Non-Clinical Performance Data: The submission includes tests like Range of Motion, Neck Fatigue Assessment, Stem Fatigue Test, Characterization of HA Plasma Spray Coating, and Usability Evaluation. These are standard engineering and material tests for orthopedic implants, not AI/ML performance metrics.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size and data provenance for a test set (for AI/ML).
• Number and qualifications of experts for ground truth (for AI/ML).
• Adjudication method (for AI/ML).
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data, etc.) for AI/ML validation.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is about a physical orthopedic implant and its substantial equivalence based on mechanical and material testing, not an AI/ML diagnostic or assistive device.

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The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature

The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.

The provided document is a 510(k) summary for a medical device called OBSIDIO™ Conformable Embolic. It states that this 510(k) submission is to implement labeling updates as part of mitigations for a recent Class I Recall and that no new safety or effectiveness issues were raised during the device testing. The document highlights that the subject device has the same intended use, indications for use, and technological characteristics as its predicate device (also OBSIDIO™ Conformable Embolic, K213385 cleared July 1, 2022).

Therefore, this document does not contain information about acceptance criteria and a study proving the device meets those criteria for the current submission, as the submission is for labeling updates and asserts substantial equivalence based on the technological identity with the predicate and prior testing. The "summary of non-clinical performance testing" refers to "use characterization analysis" to support label updates, not a new clinical or performance study to establish new acceptance criteria or device performance.

Consequently, I cannot provide the requested information. The document explicitly states:

• "No new safety or effectiveness issues were raised during the device testing."
• "This 510(k) was submitted to implement labeling updates as part of mitigations for a recent Class I Recall."
• "The subject and predicate OBSIDIO™ Conformable Embolic have the same technical characteristics."
• "Predicate and subject device intended use / indications for use are the same."

These statements confirm that no new study was conducted to establish new performance criteria or to re-evaluate the device against existing criteria in the context of this 510(k) application. The substantial equivalence is based on the device's prior clearance (K213385).

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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The "United" Conformity Stem cementless type (K183312) is designed for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6Al-4V alloy, which conforms to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The "United" Conformity Stem cementless is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
For the subject device, it's an extension line of the 510(K) cleared device Conformity Stem cementless type (K183312), which introduces two new variations: (1) Conformity stem, coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, short neck, #4-7. The indications, design rationales, materials, major manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312).
Conformity Stem can collocate with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, coxa vara, 125° STD, collared
  Conformity stem, coxa vara, 125° STD, collared is a new coxa vara type variation of 510(k) cleared Conformity stem, coxa vara (1110-52XX, K183312). The same as this 510(k) cleared device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the distal part is coated with hydroxyapatite(HA) (ASTM F1185). In addition, the subject device is also a collared stem with a 125° neck angle. The only difference is the offset design. The subject device is standard offset, while the 510(k) cleared coxa vara collared stem (110-52XX) is high offset
• Conformity Stem, short neck, #4-7
  Conformity stem, short neck, #4-7 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, short neck, #1-3 (K183312). The design, material, coating thickness, geometrical characteristics, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, #1-3 (K183312). The only different is the stem length sizes.

This is an FDA 510(k) clearance letter for a medical device called "Conformity Stem Extension Line." This document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria. Instead, it describes mechanical analyses performed on a physical orthopedic implant.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a hip joint prosthesis, which is a physical implant, not a software device.

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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem, cemented is for cemented use only.

The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
For total hip arthroplasty, Conformity stem, cemented can be used with "United"acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented can be used with "United" bipolar prosthesis.

The provided text is a 510(k) summary for a medical device (Conformity stem, cemented) and does not describe a study involving an AI/algorithm. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical properties, FEM analysis, ROM simulation, bacterial endotoxin testing).

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/algorithm according to your request. The document explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

If this was a misunderstanding and you were looking for the acceptance criteria and performance of the hip stem itself, and not an AI or algorithm, please let me know.

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The Conformis Hip System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the Conformis Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

The Conformis Hip System is a semi-constrained, cementless artificial hip replacement system. Patient imaging (CT scans) and a combination of proprietary and off the shelf software are used to design a patient specific hip replacement system.

The Conformis Hip System consists of the following components:

a) Femoral Component:

• The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes.
• Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the Conformis Hip System. The femoral heads are available in various sizes and offsets.

b) Acetabular Component:

• The acetabular cup is manufactured from titanium alloy.
• The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes.
• The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly XE™). The liners are available in a range of sizes with varying internal diameters and offsets.
• Acetabular screws and the apex hole plug are manufactured from titanium alloy.

c) Ancillary orthopedic manual surgical instruments
Ancillary orthopedic manual surgical instruments are provided with the Conformis Hip System to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.

I am sorry, but the provided FDA 510(k) clearance letter for the Conformis Hip System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as you've outlined.

This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. It confirms that the device has similar intended use, indications for use, operating principle, materials, coatings, sterilization, and packaging as its predicate.

While it mentions "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use," and lists specific standards (ISO-7206-4, ISO 7206-6, ASTM F2996) for "Stem and neck fatigue testing," it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This product is a physical implant, not an AI/software diagnostic device, so this is not applicable).
6. Information on standalone algorithm performance. (Again, not applicable).
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that a "Detailed software description and software verification and validation testing of proprietary software" was done, but does not provide any specifics about performance metrics or acceptance criteria for this software.

Therefore, I cannot fulfill your request based on the provided text.

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The ConforMIS BeneFIT Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

• · A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• · Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, manageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fits through the acetabular shell screw holes and is driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.

The ConforMIS BeneFIT Hip System is a medical device and its acceptance criteria are established through non-clinical laboratory testing. This is a hip implant system, not a software or AI-driven device, so the typical AI/software performance metrics, ground truth establishment, and expert adjudication as described in your prompt are not applicable.

Here's an overview of the acceptance criteria and the study as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use." This implies that the device met pre-defined performance thresholds, typically based on industry standards and comparison to the predicate devices, for each of these tests.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test. Clinical trials (human test subjects) for hip implants involve sample sizes that depend on the study design (e.g., pilot studies, pivotal studies), but this document focuses on non-clinical testing for 510(k) clearance, which typically involves mechanical testing of device samples.
• Data Provenance: The data is generated from non-clinical laboratory testing conducted by ConforMIS, Inc. or its designated testing facilities. There is no information about country of origin of data in the sense of patient data, nor is it retrospective or prospective in a clinical study context.

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

• This is not applicable to the non-clinical laboratory testing described. The "ground truth" for the performance of a mechanical device like a hip implant is established by meeting predefined engineering specifications, adherence to ISO standards (e.g., for fatigue, wear), and demonstrating equivalence to predicate devices, rather than through expert consensus on interpreting patient data.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of reconciling human expert opinions on cases. Test results are typically evaluated against pre-defined engineering criteria and scientific principles.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• Not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human interpretation plays a role. This document concerns a physical implant and its mechanical properties.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

• The "ground truth" for this device, in the context of non-clinical testing, is compliance with established engineering standards (e.g., ISO standards for orthopedic implants), predefined performance specifications, and demonstrated substantial equivalence to legally marketed predicate devices. This includes meeting specified thresholds for properties like fatigue strength, wear resistance, and component integrity.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing processes are refined through engineering, material science, and iterative testing, not machine learning training.

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

• Not applicable for the reasons stated in point 8.

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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The "United" Conformity Stem cementless type is design for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6A1-4V alloy which conform to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The subject device is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.

The provided text describes a 510(k) premarket notification for a medical device called "Conformity Stem," a hip stem for hip arthroplasty. The document asserts the device's substantial equivalence to a legally marketed predicate device.

However, the content does not contain any information related to an AI/ML-driven medical device, nor does it discuss acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, AUC), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

The document focuses on the mechanical and material performance of the hip stem, including tests like stem fatigue, neck fatigue, range of motion, and fretting corrosion, all of which are standard engineering and biocompatibility evaluations for an implantable orthopedic device. It explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML device study.

To answer your request, the input text would need to describe an AI/ML device, its intended use for diagnostic or prognostic purposes, and the clinical study conducted to validate its performance according to the specified criteria.

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The iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:
• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component.

Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE.

For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.

This document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML device.

The provided text is a 510(k) summary for the Conformis iTotal Cruciate Retaining (CR) Knee Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161366) rather than establishing new performance metrics.

Here's a breakdown based on your requested information, highlighting what is and is not present in the provided text:

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

• Not present in this document. This document does not establish specific performance acceptance criteria (e.g., accuracy, precision) for a medical image analysis algorithm or AI component in the typical sense. Instead, it focuses on demonstrating that the updated software produces results comparable to the predicate software and that the overall device design and materials remain unchanged.

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

• Not present in this document. There is no mention of a test set sample size or data provenance as this 510(k) is not presenting a clinical performance study. The "test set" in this context refers to the software verification and validation testing, but no details on the data used are provided.

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 present in this document. Ground truth for clinical performance is not discussed as there is no clinical performance study being presented. For software verification, ground truth would likely be based on engineering specifications or comparisons to output from the previous software version.

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

• Not present in this document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not applicable to the type of submission described.

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

• Not present in this document. This device is a knee replacement system, and the software components are for patient-specific implant design and surgical planning. It is not an AI-assisted diagnostic tool for human readers, so an MRMC study is not relevant here.

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

• The document states "Software verification and validation testing of proprietary software" was performed. This implies standalone testing of the algorithm (software modules) to ensure they function as intended and produce expected outputs for implant design and surgical planning. However, no specific details of this testing are provided. The software's output (implant design and surgical plan) is ultimately used by human surgeons during the procedure.

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

• For the "Software verification and validation testing," the ground truth would likely be based on:
  • Engineering specifications: The software should produce designs that meet predefined geometric and functional requirements.
  • Comparison to predicate software outputs: The updated software (iTotalWorks 6.0, iTotalFem CR 1.0, iTotalTib CR 5.0, iTotal CR iView 4.0) should produce designs and plans that are equivalent or demonstrate appropriate improvements compared to the predicate software (iTotalWorks 5.1, iTotal FemJigs 3.0, iTotalTib CR 4.3, iTotal CR iView 3.0). The purpose of the changes is to improve manufacturing efficiencies through automation, implying the output should remain consistent with the validated predicate.
• No clinical "ground truth" (pathology, outcomes data) is mentioned as it's not a diagnostic device.

8. The sample size for the training set

• Not applicable/Not present. This document discusses a change in software versions (i.e., v5.1 to v6.0 for iTotalWorks, etc.) for a workflow that custom designs existing implants. It is not describing a machine learning model that was specifically "trained" on a dataset in the way an AI diagnostic algorithm would be. The "proprietary and off-the-shelf software" uses patient imaging to design a patient-specific implant based on pre-defined algorithms and rules, not necessarily a training phase with a distinct training set.

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

• Not applicable/Not present. As there's no explicitly defined "training set" in the context of an AI/ML model for this device, there's no discussion of how ground truth for such a set was established.

In summary:

This 510(k) pertains to a knee replacement system where the software is used for patient-specific implant design and surgical planning. The submission is a modification to an already cleared device and focuses on demonstrating that changes to the software modules for CAD manufacturing processes do not alter the substantial equivalence of the device to its predicate. The "study" mentioned is "Software verification and validation testing of proprietary software," which ensures the new software performs as intended and produces results consistent with the previously cleared versions. This is a technical (engineering) validation rather than a clinical performance study with human readers or AI diagnostic capabilities.

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The iTotal® PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only.

The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.

The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)s K160025 & K153217.

This document describes the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System (iTotal PS) and its substantial equivalence determination. However, it does not contain information about acceptance criteria for device performance or a study demonstrating the device meets specific performance criteria in the way typical for AI/ML device evaluations.

The "study" referenced in this document concerns software verification and validation, aimed at demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical performance study with acceptance criteria and ground truth.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here is a breakdown of what can be answered and what cannot:

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

• Acceptance Criteria: Not explicitly stated as performance metrics with thresholds in this document. The "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, particularly regarding software verification and validation.
• Reported Device Performance: The document states that "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use." The specific performance metrics for the device itself (e.g., accuracy of cuts, implant fit) are not reported in this summary, nor are quantitative acceptance criteria for such metrics.

2. Sample sized 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 document. The "tests" mentioned are software verification and validation, not clinical test sets with patient data.

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

• Not applicable as this document focuses on software validation and substantial equivalence, not a clinical study requiring expert-established ground truth for a test set.

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

• Not applicable.

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

• Not applicable. This is not an AI/ML diagnostic or assistive device in the context of human reader improvement. The software generates patient-specific surgical guides, not interpretations for human readers.

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

• The document implies that the "iTotal FemJigs PS v1.0" and "iTotal TibJigs PS v1.0" software modules automate the generation of iJigs. The "software verification and validation testing" performed on these proprietary software modules could be considered a form of standalone testing for the algorithm's output (i.e., the iJigs design). However, specific performance metrics for this standalone algorithm are not presented.

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

• For the software verification and validation, the ground truth would likely involve established engineering specifications, design requirements, and comparisons against outputs generated by the previous manual process or predicate software versions. It is not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• This information is not provided. The document describes software that "automates the generation of the iTotal PS iJigs" using "proprietary software modules iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0". It doesn't explicitly state that these modules comprise a machine learning model that requires a "training set" in the conventional sense. It's possible the software uses rule-based systems or sophisticated algorithms developed through engineering rather than machine learning on a large dataset.

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

• Not applicable, as a training set is not explicitly mentioned or implied to be used for machine learning in the conventional sense. If the software involves AI/ML, this information is not disclosed.

Summary from the document:

The ConforMIS iTotal® PS Knee Replacement System (iTotal PS) received a 510(k) clearance based on its substantial equivalence to predicate devices (K160025 and K153217). The primary focus of this submission was on modifications involving the automation of the generation of iTotal PS iJigs (surgical guides) using new proprietary software modules (iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0).

The study that "proves the device meets the acceptance criteria" in this context is the software verification and validation testing performed on these new proprietary software modules. The "acceptance criteria" were met by demonstrating that the modifications did not alter the fundamental technological characteristics, materials, design, manufacturing, packaging, or sterilization of the device and that the new automated process was equivalent to the previous methods (manual or older software).

The document states: "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use. The following non-clinical laboratory testing was performed: Detailed software description and software verification and validation testing of proprietary software iTotal FemJigs PS v1.0. Detailed software description and software verification and validation testing of proprietary software iTotal TibJigs PS v1.0."

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The iTotal® Posterior Stabilized (PS) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity. Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.

The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from cobalt chromium molybdenum alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the modified iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.

The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)s K152704, K142404 and K142161.

The provided text is a 510(k) summary for the ConforMIS iTotal® Posterior Stabilized Knee Replacement System (iTotal PS KRS). The purpose of this summary is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for an AI/device performance study is not present in this document.

The document discusses a modification to an existing device, specifically "adding the option of automating the generation of the iTotal PS iView using the proprietary software module iTotal PS iView v1.0." The relevant "study" for this modification is primarily software verification and validation.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria for device performance in the typical sense of accuracy, precision, sensitivity, specificity, etc., as it is a 510(k) summary focused on demonstrating substantial equivalence of a modified manufacturing process of a medical device, not a new AI diagnostic or prognostic device's performance.

The "performance" criteria for the software modification are related to its functionality and reliability in automating the generation of the iTotal PS iView, which would be assessed through software verification and validation. No quantitative performance metrics are reported in this summary.

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

• Test Set Sample Size: Not applicable in the context of an AI performance study. The testing performed was "Detailed software description and software verification and validation testing of proprietary software iTotal PS iView v1.0." The number of test cases or data points used during this software testing is not specified.
• Data Provenance: Not applicable in the context of an AI performance study. The document refers to patient imaging (CT scans) being used to design the patient-specific implant, but this is part of the original design process, not a test set for the "iView v1.0" software. The source or nature of data used for software testing is not detailed (e.g., synthetic, real patient scans, number of scans).

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

Not applicable. This document does not describe a study involving expert-established ground truth for a test set. The modification is about software automation in the manufacturing process, not expert interpretation of outputs.

4. Adjudication method for the test set

Not applicable. As there is no described test set involving expert ground truth, no adjudication method is mentioned.

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. An MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a manufacturing process modification (software automation), not on human reader performance with or without AI assistance.

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

This document describes "Software verification and validation testing of proprietary software iTotal PS iView v1.0." This testing would inherently be assessing the algorithm's performance in generating the iView, so it can be considered a standalone assessment of the software module. However, specific performance metrics are not provided. The entire ConforMIS iTotal PS KRS system requires human-in-the-loop (surgeon) for implantation, but the iView generation itself is an automated step.

7. The type of ground truth used

For the software verification and validation of the iTotal PS iView v1.0, the ground truth would likely be established by comparing the automatically generated iViews to manually generated iViews (the predicate process) or to predefined specifications/requirements for the iView output. The document doesn't explicitly state the type of ground truth, but for software testing, it would involve functional correctness and adherence to design specifications.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model that requires a training set in the conventional sense. The "iTotal PS iView v1.0" is described as a "proprietary software module" for automating a process, implying it's a rule-based or algorithmic system rather than a deep learning model trained on a large dataset.

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

Not applicable, as no training set for a machine learning model is mentioned.

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