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The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD) of the proximal femur using digital antero-posterior hip or pelvis radiographic images. This information may be used by the physician in the assessment of fracture risk in conjunction with the World Health Organization ("WHO") criteria and to compare the derived BMD estimate with reference populations of young (20 - 39) and age matched normals to compute T-scores and Z-scores respectively.

The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays. The program utilizes a quantitative bone structural algorithm that measures a composite of weighted cortical and trabecular parameters in proximal femur projection radiographs from which total hip bone mineral density (BMD) is mathematically derived. Image analysis can take place remotely or at the point of care.

The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score).

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance validation against predefined criteria.

However, based on the available information, I can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to "standard methods for evaluation of BMD estimates," implying that the device's performance was compared against established benchmarks or methods for BMD measurement.

• Reported Device Performance:

  • The document states: "The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age."
  • It also mentions: "Software validation was performed using standard techniques."
  • The results are "expressed as gm/cm2" and "can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score)."

  Table (Inferred Acceptance Criteria based on common BMD device evaluation and what's mentioned):

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "patient populations including patients across the spectrum of age" but does not give a number.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be clinical data used for evaluation, but whether it was retrospective or prospective is not mentioned.

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

• This information is not provided in the document. The document refers to "standard methods for evaluation of BMD estimates," but does not detail how ground truth was established for the specific dataset used in their evaluation.

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

• This information is not provided in the document.

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:

• An MRMC comparative effectiveness study is not mentioned in the document. The device is a "stand-alone software" intended to provide an estimate of BMD, not explicitly an AI-assisted interpretation tool for human readers in the way an MRMC study typically evaluates. It processes images to derive BMD, which physicians then use in their assessment.

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

• Yes, the device is described as "stand-alone software" and "algorithm only" in its function of estimating BMD. The document states: "The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD)..." and "The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays." This confirms it's a standalone algorithmic performance.

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

• The direct ground truth for BMD values would typically come from reference BMD measurements (e.g., from a DEXA scan, which is considered the gold standard for clinical BMD) or potentially from a very meticulously calibrated physical phantom. The text only mentions "standard methods for evaluation of BMD estimates," but does not specify the ground truth methodology used for their evaluation studies.

8. The sample size for the training set:

• The document does not mention the sample size for a training set. This summary describes an evaluation of the device as a whole, not the specifics of its development (like training data for an AI model, even though it uses an "algorithm").

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

• This information is not provided as the training set itself is not mentioned.

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The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:

Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.

The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.

Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed.

The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.

The provided document describes a 510(k) premarket notification for the "Knee Interpositional Mini-Repair System (KIMRS)" by Imaging Therapeutics, Inc. The primary purpose of this submission is to demonstrate substantial equivalence to predicate devices, rather than to prove that the device meets specific acceptance criteria through a clinical study. The study conducted is a bench test on cadaveric knees comparing the mechanical movement of the KIMRS with a predicate device, the Centerpulse Unispacer.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating comparability to a legally marketed predicate device (Centerpulse Unispacer). The "acceptance criteria" are thus implicitly that the KIMRS performs similarly or better than the predicate device in terms of movement within the cadaveric knee. The text concludes that "The ImaTx Knee Interpositional Mini-Repair System performed comparably to the Unispacer implant."

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

• Sample Size for Test Set: Two cadaveric knee specimens.
• Data Provenance: Retrospective (cadaveric specimens), location not specified.

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

• This study did not involve experts establishing ground truth in the traditional sense of clinical assessment. It was a biomechanical test comparing implant movement. No information is provided regarding human experts for this specific comparative testing.

4. Adjudication Method for the Test Set

• Not applicable. This was a biomechanical measurement study, not an assessment requiring adjudication of human observations or diagnoses.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of the device in cadavers, not on human reader performance.

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

• Not applicable. This device is a physical knee implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the direct physical measurement of implant excursion within the cadaveric knee using fluoroscopy. This is akin to direct measurement/physical observation rather than expert consensus, pathology, or outcomes data. The predicate device's performance serves as a comparative benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set."

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

• Not applicable (as above).

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