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This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.

The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.

The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.

The provided text describes the acceptance criteria and a study for the Smart Peak Flow Meter (Model: B1).

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)

• Performance Test (Accuracy, Repeatability, Flow Resistance): The document states "All of the tested parameters meet the requirements in the standards," but it does not specify the sample size used for the performance testing.
• Human Factor Engineering Study:
  • Sample Size: 20 participants
  • Data Provenance: Not specified, but likely a prospective study conducted for regulatory submission.

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)

The document refers to conformance with the American Thoracic Society (ATS) Standard 2005 Revision for performance testing. For such standards, the "ground truth" is typically defined by the standard's specifications and measurement methods using reference equipment. No information is provided about human expert involvement in establishing a ground truth for the performance test itself. For the human factors study, the "ground truth" would be the observed user interaction and satisfaction, not expert medical opinion.

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

Not applicable. The performance testing relies on comparison to standardized measurements against the ATS 2005 standard, not human adjudication of medical findings. The Human Factor study measures user performance and feedback, not a diagnostic outcome requiring 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

Not applicable. The device is a "Smart Peak Flow Meter" for spirometry, which directly measures physiological parameters (PEF and FEV1). It does not involve "human readers" or AI assistance in interpreting images or data in a way that an MRMC study would be relevant.

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

The primary performance tests (accuracy, repeatability, flow resistance) are effectively standalone tests of the device's measurement capabilities against a standard. The human factors study evaluates the user interface and overall device usability for human users, making it a human-in-the-loop evaluation for that aspect. However, the core measurement functionality is standalone.

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

The ground truth for the performance tests (PEF and FEV1 accuracy) is based on the American Thoracic Society (ATS) Standard 2005 Revision. This standard defines the acceptable range and methodology for measuring these physiological parameters, likely involving calibrated reference equipment.

8. The sample size for the training set

Not applicable. The device is a measurement device for spirometry, not a machine learning or AI-driven diagnostic tool that requires a "training set" in the conventional sense.

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

Not applicable, as there is no "training set" in the context of this device.

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Indications for the Arcos™ Interlocking Distal Stem include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.

The Arcos™ Interlocking Distal Stem was designed to be a part of the Arcos™ Modular Femoral Revision System, a modular system using interchangeable stems and proximal bodies commonly seen in femoral revision surgery. The proximal bodies consist of broached, calcar-replacing, and cone-style implants, made from Ti-6Al-4V (ASTM F-136) and featuring a roller hardened taper, is fully porous coated (Ti-6AL-4V, ASTM F-1580) with a fine buffed finish on the bullet-tip. The distal stems will be offered in a range of diameters from 15-26mm and lengths of 200mm, 250mm, and 300mm. The stems are offered in porous cylindrical with proximal taper and splined tapered designs. The stem provides holes for interlocking screws to provide temporary rotational stability. The system also includes auxiliary implants to aid in fixation. The system is intended for uncemented applications

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

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

Important Note: The acceptance criteria for the "Kaessmann Transverse Screws Torsional Fatigue Test" are less quantitatively defined in the provided document. It states "determine the ability... as stated in the package insert" and that "the device was functional within its intended use." This suggests the criteria might be qualitative or specified in detail within the package insert, which is not included here.

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

• Distal Pot Fatigue Test: Six stems were used for this test.
• Kaessmann Transverse Screws Torsional Fatigue Test: The sample size for this test is not explicitly stated in the provided document. It mentions the screws were "tested... two separate times," but not the number of screws per test.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a pre-market submission for a physical medical device, these would be laboratory-based mechanical tests, not clinical studies involving human patients.

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 the type of testing performed. The studies described are mechanical engineering tests (fatigue and torsional strength) of physical components, not clinical diagnostic studies requiring expert human interpretation of data for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus ground truth among human readers/experts, which isn't relevant to mechanical bench testing.

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 was not done. This type of study relates to the performance of AI algorithms, often in diagnostic imaging, and is not relevant to the mechanical testing of orthopedic implants.

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

This is not applicable. The device described is a physical orthopedic implant system, not a software or AI algorithm.

7. The type of ground truth used

For both tests, the "ground truth" is established by engineering standards and direct physical measurement/testing against a predefined threshold (e.g., surviving 5 million cycles, demonstrating rotational stability). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are used in machine learning for AI algorithms.

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

This is not applicable for the reasons stated above.

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